Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters. Histopathological findings include epidermal hyperplasia, suprabasilar clefting, dyskeratosis and acantholysis of keratinocytes. A final diagnosis of HHD is usually confirmed based on clinical and histopathological findings in line with genetic testing.
Several treatment options have been proposed for this chronic and disabling disorder, however, there is no reproducibly effective therapeutic for it.
The primary objective is to evaluate the treatment response of guselkumab. Single-center, non-randomized, single-arm, open-label, phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD.

Start Date13 Mar 2025

Sponsor / Collaborator

Yale University

[+1]

NCT06586281

/ RecruitingNot ApplicableIIT

Elucidating Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Arthritis (PsA) Disease Severity With Guselkumab Therapy

While many studies examine Nonalcoholic fatty liver disease (NAFLD), little is known about its progression to high-risk nonalcoholic steatohepatitis (NASH) in PsA patients. Shared disease mechanisms may explain the increased severity in PsA. This study involves two visits from PsA patients with NAFLD and active disease signs (e.g., swollen joint, enthesitis, or psoriatic plaque). It aims to assess the impact of biological therapies on liver disorders, joints, and skin in PsA patients.

Start Date01 Jan 2025

Sponsor / Collaborator

University of California San Diego

[+1]

NCT06563323

/ Not yet recruitingPhase 2IIT

A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum

A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)

Start Date01 Jan 2025

Sponsor / Collaborator

Oregon Health & Science University

[+2]

100 Clinical Results associated with Guselkumab

100 Translational Medicine associated with Guselkumab

100 Patents (Medical) associated with Guselkumab

757

Literatures (Medical) associated with Guselkumab

01 Dec 2025·IMMUNOLOGIC RESEARCH

Residual non-specific and disease-specific inflammatory markers in successfully treated young psoriasis patients: a cross-sectional study

Article

Author: Kraner Šumenjak, Tadeja ; Merzel Šabović, Eva Klara ; Božič Mijovski, Mojca ; Janić, Miodrag

Abstract:

Psoriasis is a chronic, immune-mediated disease. The systemic inflammation triggered by psoriasis contributes significantly to increased cardiovascular risk. While various treatments completely clear the skin, the associated effects on systemic inflammation are not yet clear. We investigated residual systemic inflammation in successfully treated patients. Circulating disease-specific and non-specific inflammatory markers were measured and compared in 80 psoriasis patients (aged 30–45 years) successfully treated with topical therapy, methotrexate, adalimumab, secukinumab or guselkumab, and in 20 healthy controls. Non-specific inflammatory markers (high-sensitivity C-reactive protein (hs-CRP), complete blood count (CBC) parameters, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), mean platelet volume-to-platelet ratio (MPR), and red blood cell distribution width-to-platelet ratio (RPR)) and disease-specific inflammatory markers (interferon-γ (IFN-γ), tumor necrosis factor (TNF), interleukin (IL)-1β, IL-12p70, IL-17, and IL-23) were measured and compared between groups. Disease-specific cytokines (IFN-γ, TNF, IL-1β, IL-12p70, and IL-17, but not IL-23), were significantly elevated in patients compared to controls, while non-specific inflammatory markers showed no differences compared to controls. The residual disease-specific cytokines were similarly elevated in all five treated groups. In addition, they correlated significantly with body mass index (BMI) and waist circumference. Our results suggest that psoriasis patients have elevated residual disease-specific cytokines despite successful treatment, while the non-specific inflammatory markers are similar to those in control subjects. Residual disease-specific inflammatory markers correlated with BMI and waist circumference. A possible beneficial effect of body weight control in psoriasis patients merits further investigation. The study was registered at http://clinicaltrials.gov (identifier: NCT05957120) on July 24, 2023.

01 Apr 2025·ALIMENTARY PHARMACOLOGY & THERAPEUTICS

Clinical Trial to Assess the Safety and Tolerability of Anti‐IL 23 Monoclonal Antibody Guselkumab in Patients With Alcohol‐Associated Liver Disease

Article

Author: Morris, Sheldon ; Kim, Susy M. ; Momper, Jeremiah D. ; Pham, Thuy ; Miller, Grant ; Jamieson, Catriona ; Dave, Shravan ; Brenner, David ; Diaz, Luis Antonio ; Loomba, Rohit ; He, Feng ; Carvalho‐Gontijo Weber, Raquel ; Bettencourt, Ricki ; Fulinara, Christian ; Richards, Lisa ; Kisseleva, Tatiana ; Jain, Sonia ; Madamba, Egbert ; Sarik, Wathnita

ABSTRACT:

Background:

There are no FDA‐approved therapies for alcohol‐associated liver disease (ALD). Preclinical studies indicate that blocking IL‐23/IL‐17 signalling may reverse liver injury. Guselkumab, an IL‐23‐specific antibody approved for psoriasis, may be beneficial for ALD.

Aims:

We aimed to assess the safety and tolerability of guselkumab in patients with ALD.

Methods:

This phase‐1 dose‐escalation study included patients with ≥ 2 DSM‐5 criteria for alcohol use disorder, significant steatosis (MRI‐PDFF ≥ 8%) and MRE < 3.63 kPa (to exclude advanced disease). Guselkumab was given subcutaneously on Days 1 and 29 in 30, 70 or 100 mg dose cohorts. Primary endpoints were adverse events (AEs) and dose‐limiting toxicity.

Results:

We enrolled 13 patients (three 30 mg, three 70 mg, and seven 100 mg). Eleven completed the study and two early discontinued in the 100 mg group. Of them, 77% were men, and the median age was 53 [IQR 49–61] years. The median MRI‐PDFF and MRE were 18.4% [IQR 8.4%–34.0%] and 2.5 [2.2–2.6] kPa, respectively. The most frequent AEs were hyperuricemia (13%, mild only) and elevated lipase (11%, mild and moderate). There were no serious adverse events or significant variations in liver enzymes. There was a suppression of peripheral interleukin (IL)‐17, IL‐23, IL‐1b and TNF‐α in the 70 and 100 mg groups, and a significant decrease in alcohol consumption over time (AUDIT‐C: 6 [3–7] vs. 5 [1–6], p = 0.023).

Conclusions:

Guselkumab is safe in doses up to 100 mg and may reduce inflammation markers in ALD. These findings support further phase 2 studies to evaluate the efficacy of guselkumab in ALD, particularly in patients with severe phenotypes.

18 Mar 2025·BRITISH JOURNAL OF DERMATOLOGY

Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomized placebo-controlled PROTOSTAR study

Article

Author: Wilsmann-Theis, Dagmar ; Jett, Meg ; Jiang, Gigi ; Paller, Amy S ; Prajapati, Vimal H ; Szakos, Erzsebet ; Li, Shu ; Crauwels, Herta ; van Hartingsveldt, Bart ; Seyger, Marieke M B ; Sinha, Vikash ; DeKlotz, Cynthia M C ; Kaszuba, Andrzej

Abstract:

Background:

No currently approved treatment for paediatric plaque psoriasis selectively targets interleukin (IL)-23. In adults, guselkumab (a selective IL-23 inhibitor that targets the p19 subunit) demonstrated substantial efficacy with a favourable safety profile in treating moderate-to-severe plaque psoriasis.

Objectives:

To evaluate the efficacy and safety of guselkumab in paediatric patients with moderate-to-severe plaque psoriasis (PROTOSTAR; NCT03451851).

Methods:

This phase III randomized placebo-controlled study enrolled patients aged ≥ 6 to < 18 years with moderate-to-severe plaque psoriasis. In part 1 [week (W)0–W16], patients were randomized to receive guselkumab, placebo or open-label etanercept (active reference arm). At W16, part 1 patients entered a guselkumab withdrawal/retreatment period or continued/crossed over to receive guselkumab (W16–W52). Co-primary endpoints were Investigator Global Assessment (IGA) 0/1 and ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) [or U.S. Food and Drug Administration-required ≥ 90% improvement in PASI (PASI 90) co-primary endpoint] responses at W16 of part 1. Part 2 evaluated continuous open-label guselkumab treatment (W0–W52).

Results:

Of 92 and 28 patients enrolled in parts 1 and 2, respectively, 86% and 96% continued treatment through W52. In part 1, at W16, significantly higher proportions of guselkumab-treated compared with placebo-treated patients achieved IGA 0/1 (66% vs. 16%; P < 0.001), PASI 75 (76% vs. 20%; P < 0.001) and PASI 90 (56% vs. 16%; P < 0.01). More than one-third of guselkumab-treated patients achieved clear skin [IGA 0: 39% vs. 4% placebo; 100% improvement in PASI (PASI 100): 34% vs. 0% placebo; both P < 0.01]. In part 2, at W52, 86%, 93% and 82% of guselkumab-treated patients achieved IGA 0/1, PASI 75 and PASI 90, respectively. Through W16 of part 1, 42%, 68% and 58% of guselkumab-, placebo- and etanercept-treated patients, respectively, experienced adverse events (AEs). Rates of AEs with guselkumab were similar through W52 in parts 1 and 2; common AEs included nasopharyngitis, upper respiratory tract infection and COVID-19. No serious or opportunistic infections occurred.

Conclusions:

Guselkumab demonstrated significant and clinically meaningful responses in paediatric patients with moderate-to-severe plaque psoriasis, and all co-primary and major secondary endpoints were met. Safety outcomes for guselkumab in paediatric patients were similar to placebo and consistent with the established profile in adults, with no new safety signals identified. These findings support the use of guselkumab to treat paediatric patients with moderate-to-severe plaque psoriasis.

229

News (Medical) associated with Guselkumab

24 Mar 2025

·www.drugs.com

FDA Approves Tremfya for Active Crohn Disease in Adults

MONDAY, March 24, 2025 -- The U.S. Food and Drug Administration has approved Tremfya (guselkumab) for adult patients with moderately to severely active Crohn disease. This approval is the fourth indication for this dual-acting interleukin-23 inhibitor in the United States, making Tremfya the first and only interleukin-23 inhibitor offering both subcutaneous and intravenous induction options for adults with Crohn disease. The approval is based on data from three phase 3 trials. In the GRAVITI study, Tremfya (400 mg subcutaneous induction at weeks 0, 4, and 8) led to significantly higher clinical remission (56 versus 22 percent) and endoscopic response (34 versus 15 percent) when compared with placebo. Similar results were seen in the GALAXI 2 and GALAXI 3 trials, which compared Tremfya 200 mg intravenous induction at weeks 0, 4, and 8 with placebo. "Despite the progress in the management of Crohn's disease, many patients experience debilitating symptoms and are in need of new treatment options," lead investigator of the GRAVITI study, Remo Panaccione, M.D., from the University of Calgary in Alberta, Canada, said in a statement. "Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before." Approval of Tremfya was granted to Johnson & Johnson. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultPhase 3Drug Approval

21 Mar 2025

·pipelinereview.com

U.S. FDA approves TREMFYA® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options, for adult patients with moderately to severely active Crohn's disease

TREMFYA ® is the only IL-23i to demonstrate clinical remission and endoscopic response, both at one year, with a fully subcutaneous induction regimen Supported by data from the GALAXI study, TREMFYA ® is the only IL-23i to show superiority versus STELARA ® in all pooled endoscopic endpoints within a double-blinded registrational trial TREMFYA ® approval in Crohn’s disease builds upon recent ulcerative colitis FDA approval, marking the fourth indication for this dual-acting IL-23i in the U.S. HORSHAM, PA, USA I March 20, 2025 I Johnson & Johnson (NYSE: JNJ ) today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA ® (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn’s disease (CD), a chronic inflammatory condition of the gastrointestinal tract. 1 This milestone builds upon the FDA approval of TREMFYA ® in moderately to severely active ulcerative colitis (UC), one of two main forms of inflammatory bowel disease (IBD), 2 which impacts the lives of nearly three million Americans. 3 TREMFYA ® is the first and only approved fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including CD. 4,5,6,7,8 “Despite the progress in the management of Crohn’s disease, many patients experience debilitating symptoms and are in need of new treatment options,” said Remo Panaccione, MD, FRCPC, Professor of Medicine and the Director of the Inflammatory Bowel Disease Unit at the University of Calgary and lead investigator of the Phase 3 GRAVITI study. “The approval of TREMFYA offers an IL-23 inhibitor that has shown robust rates of endoscopic remission with both subcutaneous and intravenous induction regimens. Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before.” This approval is supported by results from multiple rigorous Phase 3 trials evaluating more than 1,300 patients with moderately to severely active CD who failed or were intolerant to conventional therapy (i.e. corticosteroids or immunomodulators) or biologics. 6 The GRAVITI study evaluated TREMFYA ® SC induction and maintenance therapy versus placebo. Data from the GALAXI clinical program showed TREMFYA ® was superior to STELARA ® in all pooled endoscopic endpoints, the only IL-23 inhibitor to achieve this in a double-blinded registrational program. The comprehensive results from these Phase 3 studies demonstrated the robust efficacy of SC or IV TREMFYA ® in achieving clinical and endoscopic endpoints. Highlights from these pivotal studies showed: 6 “TREMFYA is the first and only IL-23 inhibitor that offers a fully subcutaneous treatment option for moderately to severely active Crohn’s disease. With the approval of TREMFYA, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start,” said Chris Gasink, MD, Vice President, Medical Affairs, Gastroenterology & Autoantibody, Johnson & Johnson Innovative Medicine. “TREMFYA provides people living with Crohn’s disease and their healthcare providers a new treatment option that is supported by data from multiple Phase 3 studies, including pooled analyses showing statistical superiority versus STELARA across four endoscopic or combined clinical and endoscopic endpoints.” TREMFYA ® dosing in the treatment of moderately to severely active CD: 6 Johnson & Johnson is committed to supporting access to all its treatments, including offering a patient support program called TREMFYA ® withMe. For commercially insured patients, adults who are prescribed TREMFYA ® for CD may be eligible to receive their first induction treatment in as little as 24 hours through TREMFYA ® withMe. This approval marks the fourth indication for TREMFYA ® in the U.S., following moderate-to-severe plaque psoriasis in July 2017, active psoriatic arthritis in July 2020 and moderately to severely active UC in September 2024, 6 underscoring Johnson & Johnson’s long-standing legacy in innovation and commitment to patients living with chronic immune-mediated diseases, including IBD. In November 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval of a SC induction regimen of TREMFYA ® for the treatment of adults with moderately to severely active UC, based on results of the Phase 3 ASTRO study. Editor’s Notes: a) CD64+ cells are the predominant source of IL-23 in CD. Cells not expressing CD64 may also contribute to IL-23 production but to a lesser extent. 1,3 b) “Only” based on approved selective IL-23 inhibitors for moderately to severely active CD as of March 2025. 6,7,8 c) Based on in vitro studies in an inflammatory monocyte model. 4 d) Moderately to severely active CD was defined as a Crohn’s Disease Activity Index (CDAI) score of ≥220 and a Simple Endoscopic Score for Crohn’s Disease (SES-CD) of ≥6 (or ≥4 for subjects with isolated ileal disease). 6 e) Clinical remission was defined as a CDAI score of <150. ,6 f) Endoscopic response is defined as >50% improvement from baseline in SES-CD score. 6 g) Endoscopic remission was defined as an SES-CD score ≤4 and at least a 2-point reduction from baseline and no subscore greater than 1 in any individual component. 6 h) q4w is defined as every four weeks. 6 i) q8w is defined as every eight weeks. 6 j) Dr. Panaccione is a paid consultant for Johnson & Johnson. He has not been compensated for any media work. ABOUT THE GRAVITI STUDY ( NCT05197049 ) GRAVITI is a randomized, double-blind, placebo-controlled Phase 3 study to evaluate guselkumab SC induction therapy (400 mg at Weeks 0, 4, and 8) in patients with moderately to severely active Crohn’s disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab). 10 Patients received guselkumab 400 mg SC q4w (x3) followed by guselkumab 200 mg SC q4w; or guselkumab 400 mg SC q4w (x3) followed by guselkumab 100 mg SC q8w; or placebo. The maintenance doses in GRAVITI (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 GALAXI 2 and GALAXI 3 studies that evaluated the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active Crohn’s disease. Similar to GALAXI, GRAVITI employed a treat-through design, in which patients were randomized to guselkumab at Week 0 and remained on that regimen throughout the study, regardless of clinical response status at the end of induction. Participants randomized to placebo were able to receive guselkumab (400 mg SC q4w x3 ➔ 100 mg SC q8w) if rescue criteria were met at Week 16. 10 ABOUT THE GALAXI PROGRAM ( NCT03466411 ) GALAXI is a randomized, double-blind, placebo-controlled, active-controlled (ustekinumab), global, multicenter Phase 2/3 program designed to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease with inadequate response/intolerance to conventional therapies (corticosteroids or immunomodulators) and/or biologics (TNF antagonists or vedolizumab). 11 GALAXI includes a Phase 2 dose-ranging study (GALAXI 1) and two independent, identically designed confirmatory Phase 3 studies (GALAXI 2 and 3). 11 Each GALAXI study employed a treat-through design in which participants remained on the treatment to which they were initially randomized and includes a long-term extension study that will assess clinical, endoscopic, and safety outcomes with guselkumab through a total of five years. Patients received guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8 followed by guselkumab 200 mg subcutaneous maintenance every 4 weeks; or guselkumab 200 mg intravenous induction at Weeks 0, 4 and 8, followed by guselkumab 100 mg subcutaneous maintenance every 8 weeks; or a biologic active control; or placebo. Participants randomized to placebo were able to receive ustekinumab if clinical response was not met at Week 12. Of the 873 individuals pooled across the GALAXI 2 & 3 dataset, 456 (52 percent) had prior history of inadequate response to biologics, 365 (42 percent) were biologic-naïve and 52 (6 percent) were biologic experienced without documented inadequate response or intolerance. 12 The GALAXI 2 and GALAXI 3 studies were the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus ustekinumab in Crohn’s disease, showing guselkumab was superior to ustekinumab in all endoscopic-based endpoints when analyzed with pooled data. ABOUT CROHN’S DISEASE Crohn’s disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans. 3 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. 1 Symptoms of Crohn’s disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever. Currently no cure is available for Crohn’s disease. 3 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA ® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA ® is a prescription medicine approved in the U.S. to treat: TREMFYA ® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA ® . For more information, visit: www.tremfya.com . Please read the full Prescribing Information , including Medication Guide , for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch , or call 1-800-FDA-1088 . Dosage Forms and Strengths : TREMFYA ® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT STELARA® (ustekinumab) STELARA ® (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist, is a prescription medicine approved in the United States to treat. 13 The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA ® . Please click to read the full Prescribing Information and Medication Guide for STELARA® and discuss any questions you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com . Follow us at @JNJInnovMed . Janssen Research & Development, LLC, Janssen Scientific Affairs, LLC, Janssen Biotech, Inc., and Janssen-Cilag International NV are Johnson & Johnson companies. 1 Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes . Accessed February 2025. 2 Crohn’s & Colitis Foundation. What is Crohn’s disease? Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes . Accessed February 2025. 3 Crohn’s & Colitis Foundation. Overview of Crohn’s disease. Available at: https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview . Accessed March 2025. 4 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn’s and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 5 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 6 TREMFYA ® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 7 Skyrizi ® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 8 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 9 Panaccione, R, et al. Efficacy and Safety of Subcutaneous Guselkumab Induction Therapy in Patients With Moderately to Severely Active Crohn’s Disease: Results Through Week 48 From the Phase 3 GRAVITI Study. Oral presentation (OP72) at American College of Gastroenterology (ACG) 2024. 10 National Institutes of Health: Clinicaltrials.gov. A study of guselkumab subcutaneous therapy in participants with moderately to severely active Crohn’s disease (GRAVITI). Identifier: NCT05197049. Available at: https://classic.clinicaltrials.gov/ct2/show/NCT05197049 . Accessed February 2025. 11 National Institutes of Health: Clinicaltrials.gov. A study of the efficacy and safety of guselkumab in participants with moderately to severely active Crohn’s disease (GALAXI). Identifier: NCT03466411. Available at: https://clinicaltrials.gov/study/NCT03466411 . Accessed February 2025. 12 Danese S, et al. Week 48 efficacy of guselkumab and ustekinumab in Crohn’s disease based on prior response/exposure to biologic therapy: Results from the GALAXI 2 & 3 Phase 3 Studies. Poster presentation (Abstract MP672) at United European Gastroenterology Week (UEGW) 2024. October 2024. 13 STELARA ® Prescribing information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf Accessed March 2025. SOURCE: Johnson & Johnson

Clinical ResultPhase 3Drug Approval

21 Mar 2025

·www.pharmaceutical-technology.com

FDA approves Johnson & Johnson’s Tremfya to treat Crohn’s disease

Johnson & Johnson developed the dual-acting monoclonal antibody. Credit: Skorzewiak/Shutterstock. Johnson & Johnson (J&J) has received US Food and Drug Administration (FDA) approval for its interleukin 23 inhibitor, Tremfya (guselkumab), to treat moderately to severely active Crohn’s disease (CD) in adults. The approval introduces the therapy with both subcutaneous (SC) and intravenous (IV) induction alternatives for this gastrointestinal tract’s chronic inflammatory condition. The fully human dual-acting monoclonal antibody attaches to the cluster of differentiation 64, targeting inflammation at its cellular source. This milestone follows the drug’s previous approval from the agency for ulcerative colitis, another form of inflammatory bowel disease. The latest decision is based on the outcomes from several Phase III trials, which comprised more than 1,300 CD subjects who were not tolerant to conventional treatments or biologics. The GRAVITI trial evaluated SC induction of the antibody and maintenance therapy against a placebo. GALAXI clinical programme data revealed that the antibody was superior to Stelara across all pooled endoscopic endpoints. The comprehensive findings from these Phase III trials showcased the efficacy of both SC and IV formulations of the antibody in meeting endoscopic and clinical endpoints. J&J innovative medicine gastroenterology and autoantibody medical affairs vice-president Chris Gasink stated: “With the approval of Tremfya, it is now possible to achieve meaningful improvements in clinical and endoscopic outcomes with the flexibility of self-administration from the start. “Tremfya provides people living with CD and their healthcare providers a new treatment option that is supported by data from multiple Phase III studies, including pooled analyses showing statistical superiority versus Stelara across four endoscopic or combined clinical and endoscopic endpoints.” Tremfya’s latest approval marks its fourth indication in the country. In November 2024, the company submitted a supplemental biologics licence application to the US regulator for an SC induction regimen of the antibody for UC. In January, 2025, J&J’s nasal spray Spravato secured a label expansion from the FDA for use as a single agent in adults with major depressive disorder (who were not responsive to two oral antidepressants.

Phase 3Drug ApprovalClinical ResultBiosimilar

100 Deals associated with Guselkumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10438	Guselkumab	L04AC16	DB11834

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Colitis, Ulcerative	Japan	Janssen Pharmaceutical KK	27 Mar 2025
Crohn's disease, active moderate	China	Janssen-Cilag International NV	20 Feb 2025
Crohn's disease, active severe	China	Janssen-Cilag International NV	20 Feb 2025
Ulcerative colitis, active moderate	United States	Janssen Biotech, Inc.	11 Sep 2024
Ulcerative colitis, active severe	United States	Janssen Biotech, Inc.	11 Sep 2024
Pustulosis of Palms and Soles	Japan	Janssen Pharmaceutical KK	21 Nov 2018
Erythrodermic psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Pustular psoriasis	Japan	Janssen Pharmaceutical KK	23 Mar 2018
Arthritis, Psoriatic	European Union	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Iceland	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Liechtenstein	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Norway	Janssen-Cilag International NV	10 Nov 2017
Plaque psoriasis	United States	Janssen Biotech, Inc.	13 Jul 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	NDA/BLA	United States	Johnson & Johnson	02 Dec 2024
Crohn Disease	NDA/BLA	China	Xian-Janssen Pharmaceutical Ltd.	06 Mar 2024
Pediatric Crohn's Disease	Phase 3	United States	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Japan	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Austria	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Belgium	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Brazil	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	France	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Israel	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Italy	Janssen Research & Development LLC	13 Mar 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05197049 (GRAVITI, CTgov)	Phase 3	Crohn Disease	350	placebo+guselkumab (Placebo)	tqbktroioh = idnptxetfl bwyhclfpwu (jaqnbltulx, qfzqhnbdwn - tjeezmhnwg) View more	-	25 Mar 2025
				Guselkumab (Combined: Guselkumab 400 mg)	tqbktroioh = touxqvwflh bwyhclfpwu (jaqnbltulx, fiijvnqmfo - rxrrqrmnlc) View more
NCT05125679 (G-CARE, CTgov)	Phase 4	Plaque psoriasis	15	Guselkumab (Guselkumab 100 mg: Nicotine Users)	bryzocnhac(mmhaehavyp) = cesgayptau mbrrsssmyw (aqbzpkgkbe, 0.2773) View more	-	25 Mar 2025
				Guselkumab (Guselkumab 100 mg: Non-Nicotine Users)	bryzocnhac(mmhaehavyp) = jhftekgemf mbrrsssmyw (aqbzpkgkbe, 0.6478) View more
FDA_CDER Manual	Not Applicable	Crohn Disease	-	Placebo	knktapjnlu(udmsgvqslg) = wcucrcpnbw hgymygnmnu (rxzsoleytr ) View more	Positive	20 Mar 2025
				TREMFYA 400 mg Subcutaneous Injection at Weeks 0, 4, and 8	knktapjnlu(udmsgvqslg) = bidsosbpnh hgymygnmnu (rxzsoleytr ) View more
NCT03466411 (FDA_CDER) Manual	Phase 2/3	Crohn Disease	721	Placebo (CD1)	ibhgligcuz(iojwavtayh) = kmaevxcpva utzxxhbngy (ksfosstwin ) View more	Positive	20 Mar 2025
				TREMFYA 200 mg Intravenous Infusion (CD1)	ibhgligcuz(iojwavtayh) = eivhaptfpi utzxxhbngy (ksfosstwin ) View more
NCT03451851 (PROTOSTAR, Pubmed \| Br J Dermatol)	Phase 3	Plaque psoriasis	-	Guselkumab	lcjihqqkqc(gunyvgwczk) = wqgffwpddv kinwxbhzed (scdispuhty ) View more	Positive	18 Mar 2025
				Placebo	lcjihqqkqc(gunyvgwczk) = duxmqihjkx kinwxbhzed (scdispuhty ) View more
NCT05528510 (ASTRO, Company_Website 1 \| Company_Website 2) Manual	Phase 3	Colitis, Ulcerative	418	TREMFYA® 400 mg SC induction	biedbubcav(lqkokxlujo) = sxupepdbvy autpcwlcma (pnosxlhmpk ) Met View more	Positive	21 Feb 2025
				Placebo	biedbubcav(lqkokxlujo) = acxtpvveiy autpcwlcma (pnosxlhmpk ) Met View more
NCT04033445 (QUASAR, Pubmed) Manual	Phase 3	Ulcerative colitis, active moderate \| Ulcerative colitis, active severe Induction \| Maintenance	-	guselkumab 200 mg (induction study)	pdxzvxlkhg(fwswoxadoo) = yxijrqpwfu lsjcmljukz (smmnlqigxf ) View more	Positive	17 Dec 2024
				Placebo (induction study)	pdxzvxlkhg(fwswoxadoo) = knnjqahict lsjcmljukz (smmnlqigxf ) View more
NCT06039189 (SPECTREM, NEWS) Manual	Phase 3	Plaque psoriasis	-	Tremfya (guselkumab)	pzcavnchvl(yjghfbxobc) = nuijknavjs nynzndfkih (sjzwrarzik ) View more	Positive	31 Oct 2024
				Placebo	pzcavnchvl(yjghfbxobc) = zbqjkitcmw nynzndfkih (sjzwrarzik ) View more
NCT05197049 (GRAVITI, Company_Website) Manual	Phase 3	Crohn Disease	-	TREMFYA® 400 mg SC q4w	fswsctipta(nwufhpjgec) = menybxbyqc nzxyilipll (dlxhljcvse ) View more	Positive	28 Oct 2024
				TREMFYA® 100 mg SC q8w	fswsctipta(zvozsfuyyz) = daoxlzhssd gzbfyknzgy (womjiztekw ) View more
NCT05784129 (PROGRESS, CTgov)	Phase 3	Crohn Disease	4	Guselkumab (Guselkumab 200 mg + Guselkumab 100 mg)	lujiixdsgk = vznyspilkr fdwhkmtccb (iebjilmthp, gwabzhmllh - lxfysromws) View more	-	28 Oct 2024
				placebo+guselkumab (Placebo)	lujiixdsgk = dnglcbqokm fdwhkmtccb (iebjilmthp, lwhqbzitbs - rtsqtguxvp) View more

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