The main purpose of the study is to investigate the efficacy on cutaneous thickness and the safety of Nemolizumab in adult patients with systemic sclerosis after a 52-week treatment period and to select the optimal dose for this target population.

Start Date15 Dec 2025

Sponsor / Collaborator

GALDERMA PHARMA SA

NCT07074977

/ RecruitingPhase 2

An Exploratory Proof of Concept Study to Assess the Pharmacokinetics/Pharmacodynamics (PK/PD) of Nemolizumab in Adult Participants With Chronic Pruritus of Unknown Origin (CPUO)

The primary objective of this study is to assess the PK/PD relationship of nemolizumab in adult participants aged 18 years or above with chronic pruritus of unknown origin (CPUO) during a 16-week treatment period.

Start Date20 Oct 2025

Sponsor / Collaborator-

JPRN-jRCT2021230034

/ SuspendedPhase 2IIT

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Nemolizumab in Patients with Acquired Reactive Perforating Collagenosis

Start Date09 Nov 2023

Sponsor / Collaborator-

100 Clinical Results associated with Nemolizumab

100 Translational Medicine associated with Nemolizumab

100 Patents (Medical) associated with Nemolizumab

172

Literatures (Medical) associated with Nemolizumab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Nemolizumab for the treatment of atopic dermatitis

Review

Author: Alvarenga, José Miguel ; Rodrigues, Erica ; Torres, Tiago ; Chovatiya, Raj ; Domingues, João

PURPOSE:

Atopic dermatitis (AD) is a common, heterogeneous inflammatory skin disease characterized by chronic or relapsing eczematous lesions and intense pruritus, leading to reduced quality of life and increased mental health burden. Despite recent therapeutic advances, moderate-to-severe AD remains challenging to manage, and conventional treatments often have limited long-term efficacy and safety concerns. Interleukin-31 (IL-31) is a key mediator in AD pathogenesis, driving pruritus, barrier dysfunction, type 2 inflammation, and fibrosis. Nemolizumab, a humanized monoclonal antibody targeting the IL-31 receptor α-chain (IL-31RA), has emerged as a novel therapeutic option.

MATERIALS AND METHODS:

This narrative review discusses current understanding of the role of IL-31 in AD pathophysiology. It also summarizes the most recent and relevant clinical trial data on the efficacy and safety of nemolizumab.

RESULTS:

Multiple phase II and III randomized clinical trials have demonstrated nemolizumab efficacy in patients with moderate-to-severe AD, with significant and sustained reductions in pruritus and overall disease severity. Furthermore, nemolizumab has shown a favorable safety profile, with most adverse events reported as mild and non-serious.

CONCLUSIONS:

IL-31 plays a critical role in the pathogenesis of atopic dermatitis. Findings from clinical trials support the efficacy and safety of nemolizumab in the treatment of moderate-to-severe AD.

11 Nov 2025·Cureus Journal of Medical Science

Concurrent Nemolizumab-Induced Cutaneous Adverse Events and Asthma Exacerbation in a Patient With Prurigo Nodularis With Resolution of Both Conditions After Switching to Dupilumab

Article

Author: Iozumi, Ken ; Mima, Yoshihito ; Yamamoto, Masako

Prurigo nodularis (PN) is a chronic pruritic inflammatory disease driven by Th2-dominant immune dysregulation and neural hyperactivity. Conventional therapies often fail, while biologics such as dupilumab and nemolizumab have shown efficacy. However, nemolizumab can cause cutaneous adverse events (cAEs) and occasional asthma exacerbation. An 82-year-old woman with long-standing PN and well-controlled asthma developed cAEs and asthma exacerbation one month after initiating nemolizumab, an IL-31 receptor antagonist. Although nemolizumab markedly improved pruritus and PN lesions, acute eczematous eruptions and erythematous papules appeared on previously unaffected skin, accompanied by worsening asthma symptoms. After switching to dupilumab (IL-4/IL-13 inhibitor), both cAEs and asthma improved, with complete resolution within two months. The mechanism underlying nemolizumab-induced cAEs and asthma remains unclear, but activation of Th2-driven inflammation following IL-31 blockade has been proposed. To our knowledge, this is the first reported case of concurrent nemolizumab-induced cAEs and asthma exacerbation in a patient with PN, successfully managed with dupilumab. Given that asthma exacerbations have occurred only in patients with preexisting asthma, careful monitoring is warranted when administering nemolizumab. Further studies are needed to clarify its mechanism and management strategies.

01 Nov 2025·INTERNATIONAL JOURNAL OF DERMATOLOGY

Nemolizumab as a Novel Therapeutic Option for Refractory Prurigo Chronica Multiformis: A Case Report

Letter

Author: Nakajima, Saeko ; Nakayama, Shota ; Kabashima, Kenji ; Yonekura, Satoru

News (Medical) associated with Nemolizumab

12 Jan 2026

·www.biospace.com

Galderma announces the authorization of NEMLUVIO® (nemolizumab) for atopic dermatitis and prurigo nodularis in Canada

NEMLUVIO is the first authorized monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31. 1 IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in both atopic dermatitis and prurigo nodularis 2-5 NEMLUVIO is now authorized for sale by Health Canada based on results from the phase III ARCADIA and OLYMPIA clinical trial programs, which showed that NEMLUVIO significantly improved itch, skin lesions and sleep disturbance in atopic dermatitis and prurigo nodularis 6-8 Atopic dermatitis, a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions, impacts up to 17% of Canadians at some point in their life 2, 9-11 Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by intense itch and thick skin nodules covering large body areas, with a prevalence that may range from 7–111 people per 100,000 12-15 THORNHILL, ON , Jan. 12, 2026 /CNW/ - Galderma Canada has announced the Health Canada authorization of NEMLUVIO (nemolizumab), a first-in-class biologic treatment for both moderate-to-severe atopic dermatitis and prurigo nodularis. NEMLUVIO was granted authorization for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Furthermore, NEMLUVIO was granted authorization for the treatment of adults with moderate-to-severe prurigo nodularis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 1 "Building on its longstanding dermatology heritage, Galderma introduces the first monoclonal antibody targeting IL-31 receptor alpha for Canadians suffering from atopic dermatitis and prurigo nodularis", said Sophie Élise Michaud, Ph.D., Head Medical Affairs, Galderma Canada Inc. "NEMLUVIO represents an important advancement that addresses a significant unmet medical need and helps alleviate the substantial disease burden faced by patients with either condition." The authorization for sale was based on robust results from the phase III ARCADIA and OLYMPIA clinical trial programs in atopic dermatitis and prurigo nodularis, respectively. The phase III ARCADIA 1 and ARCADIA 2 trials met their co-primary endpoints and all key secondary endpoints, demonstrating that NEMLUVIO, administered subcutaneously every four weeks in combination with background topical corticosteroids or topical calcineurin inhibitors (+TCS/TCI), clinically improved skin lesions, and significantly improved itch and sleep disturbance in patients aged 12 years and older with moderate-to-severe atopic dermatitis, when compared to placebo +TCS/TCI. 6 Significant itch relief was observed as early as Week 1. 6 Results from the phase III OLYMPIA 1 and OLYMPIA 2 trials showed that NEMLUVIO monotherapy met all primary and key secondary endpoints and demonstrated significant and clinically meaningful improvements on itch, skin lesions and sleep disturbance in adult patients with prurigo nodularis, compared to placebo. 7,8 Reduction in itch due to prurigo nodularis was observed as early as Week 4. 7,8 "For people living with atopic dermatitis or prurigo nodularis, itch is more than a symptom – it's often the most disruptive part of their daily lives", said Dr. Chih-ho Hong, Board-Certified Dermatologist, MD, FRCPC, Surrey, BC. "Nemolizumab's ability to rapidly target itch makes it an exciting and much-needed advancement, offering patients relief where they need it most." Atopic dermatitis and prurigo nodularis are both skin conditions driven by neuroimmune dysfunction, which manifests as itch (pruritus), inflammation, and skin barrier dysfunction in atopic dermatitis, and itch, inflammation, altered epidermal differentiation and fibrosis (thickening or scarring of skin tissue causing firm bumps) in prurigo nodularis. 2,16 In both conditions, itch is often reported as one of patients' most problematic symptoms, with 87% of atopic dermatitis patients saying that they are seeking freedom from itch, and 75% of prurigo nodularis patients reporting that persistent itch negatively impacts their quality of life. 17,18 Aside from chronic itch, patients can develop mental health disorders and suffer a psychosocial burden from developing skin nodules, which can be on visible areas of the body and significantly impact confidence and social interactions. 12,14,19,20 Scratched nodules can also bleed, increasing the risk of recurrent infections that cause additional burden. 21 Given the significant burden that these serious diseases place on patients, their families, and caregivers, 14,19 the authorization for sale of NEMLUVIO helps to address the need for new treatment options in Canada that can effectively relieve the signs and symptoms. About NEMLUVIO NEMLUVIO was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga ®  and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. 22,23 About the ARCADIA clinical trial program 6 The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients – ARCADIA 1 and ARCADIA 2. These global, randomized, multicenter, double-blind, placebo-controlled phase III clinical trials evaluated the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo (both administered in combination with background topical corticosteroids or topical calcineurin inhibitors). 6 The trials were conducted in adolescent and adult patients (12 years and over) with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks. 6 Patients who responded to treatment (defined as patients who achieved an investigator's global assessment score of clear (0) or almost clear (1), or a 75% or greater improvement in the eczema area and severity index score) were then re-randomized to a maintenance treatment phase for up to 48 weeks. 6 About atopic dermatitis Atopic dermatitis is a common, chronic, and flaring inflammatory skin disease, characterized by persistent itch and recurrent skin lesions. 2,9,10 It is the most common inflammatory skin disease, impacting almost four times more people than psoriasis. 2,10,24 It affects up to 17% of Canadians at some point in their life. 11 Itch has been reported as the most frequently occurring and most severe symptom of atopic dermatitis. Over 67% of patients reported that itch moderately to severely interfered with heir sleep, and 65% reported that they experience itch without visible rash. 25 About the OLYMPIA clinical trial program 7,8 The OLYMPIA program included two identically designed, pivotal phase III clinical trials which enrolled 560 patients – OLYMPIA 1 and OLYMPIA 2. This is the largest completed pivotal clinical trial program conducted in prurigo nodularis to date, and the only program to include a long-term extension study. These global, randomized, double-blind, placebo-controlled phase III clinical trials assessed the efficacy and safety of nemolizumab monotherapy compared with placebo in patients at least 18 years of age with moderate-to-severe prurigo nodularis over a 16- or 24-week treatment period for OLYMPIA 2 and OLYMPIA 1, respectively. About prurigo nodularis Prurigo nodularis is a chronic, debilitating, and distinct neuroimmune skin disease characterized by the presence of intense itch and thick skin nodules covering large body areas. 14 Prevalence estimates in Canada are limited, but it is estimated to affect 72 per 100,000 people in the United States and 7–111 per 100,000 people in Europe, depending on the country. 12,15 The majority of patients report that the persistent itch negatively impacts their quality of life. 18 Furthermore, the intense itch associated with prurigo nodularis results in significant sleep disturbance and further contributes to reduced quality of life. 13,20 About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: . For further information: Christian Marcoux, M.Sc. Chief Communications Officer christian.marcoux@galderma.com +41 76 315 26 50 Céline Buguet Franchises and R&D Communications Director celine.buguet@galderma.com +41 76 249 90 87 References: 1. NEMLUVIO Product Monograph. Galderma Canada Inc. 2. Langan SM, et al. Atopic dermatitis [published correction appears in Lancet. 2020;396(10253):758]. Lancet . 2020;396(10247):345-360. doi:10.1016/S0140- 6736(20)31286-1 3. Bağci IS and Ruzicka T. IL-31: A new key player in dermatology and beyond. J Allergy Clin Immunol. 2018;141(3): P858-866. doi: 10.1016/j.jaci.2017.10.045 4. Dillon SR, et al. Interleukin 31, a cytokine produced by activated T cells, induces dermatitis in mice [published correction appears in Nat Immunol. 2005;6(1):114.] Nat Immunol. 2004;5(7):752-760. doi: 10.1038/ni1084 5. Datsi A, et al. Interleukin-31: The "itchy" cytokine in inflammation and therapy. Allergy. 2021;76:2982-2997. doi: 10.1111/all.14791 6. Silverberg J, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate double-blinded, randomised controlled phase 3 trials. Lancet. 2024. doi: 10.1016/S0140-6736(24)01203-0 7. Ständer S. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1): Late breaking abstract presented at EADV 2023 8. Kwatra SG, et al. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med . 2023;389: 1579-89. doi: 10.1056/NEJMoa2301333 9. Yang G, et al. Skin Barrier Abnormalities and Immune Dysfunction in Atopic Dermatitis. Int J Mol Sci . 2020;21(8):2867. doi: 10. Ständer S. Atopic dermatitis. N Engl J Med. 2021;384(12):1136-1143. doi:10.1056/NEJMra2023911 11. Canadian Dermatology Association. Eczema. Retrieved November 13, 2025 from: . 12. Huang AH, et al. Prurigo nodularis: epidemiology and clinical features. J Am Acad Dermatol. 2020;83(6):1559-1565. doi:10.1016/j.jaad.2020.04.183 13. Pereira MP, Basta S, Moore J, Ständer S. Prurigo nodularis: a physician survey to evaluate current perceptions of its classification, clinical experience and unmet need. J Eur Acad Dermatol Venereol . 2018 Dec;32(12):2224-2229. doi: 10.1111/jdv.15107. Epub 2018 Jul 1. PMID: 29869425; PMCID: PMC6585684 14. Ständer S, et al. IFSI-guideline on chronic prurigo including prurigo nodularis. Itch . 2020;5(4):e42. doi:10.1097/itx.0000000000000042 15. Patruno C, et al. Epidemiology and Severity of Prurigo Nodularis in Europe: A Literature Review with an Application to Italian Data. Dermatol Pract Concept . 2025;15(2):4716. doi: 10.5826/dpc.1502a4716. 16. Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb) . 2022;12(9):2039–2048. doi:10.1007/s13555-022-00782-2 17. Augustin M, et al. Real-World Treatment Patterns and Treatment Benefits among Adult Patients with Atopic Dermatitis: Results from the Atopic Dermatitis Patient Satisfaction and Unmet Need Survey. Acta Derm Venereol . 2022;7: 102:adv00830. doi: 10.2340/actadv.v102.3932. 18. Todberg T, et al. Treatment and burden of disease in a cohort of patients with prurigo nodularis: a survey-based study. Acta Derm Venereol . 2020;100(8):adv00119. doi:10.2340/00015555-3471 19. Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care . 2017;23(8 suppl):S115-S123. PMID:28978208 20. Rodriguez D, et al. Patient Perspectives on Living With Severe Prurigo Nodularis. JAMA Dermatol . 2023;159(11):1205-1212. doi:10.1001/jamadermatol.2023.3251 21. Mullins TB, et al. Prurigo Nodularis. [Updated 2022 Sep 12]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023. Available online . Accessed February 2025 22. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online . Accessed February 2025 23. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermati-tis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online . Accessed February 2025 24. Raharja A, et al. Psoriasis: a brief overview. Clin Med (Lond). 2021;21(3):170-173. doi: 10.7861/clinmed.2021-0257 25. Silverberg JI, et al. Burden of Disease and Unmet Needs in Atopic Dermatitis: Results From a Patient Survey. Dermatitis . 2023 Mar-Apr;34(2):135-144. doi: 10.1089/derm.2022.29015.jsi. SOURCE Galderma

Phase 3Clinical ResultDrug Approval

05 Jan 2026

·www.biospace.com

J&J Stops Mid-stage Eczema Trial as $1.25B Asset Misses Efficacy Mark

iStock, Sundry Photography J&J paid Numab Therapeutics $1.25 billion upfront for the asset in 2024 based on the belief that its dual mechanism of action could improve on existing therapies. Johnson & Johnson has stopped a Phase IIb trial testing a treatment for atopic dermatitis after interim data fell short of the efficacy bar to warrant the study’s continuation. The company designed the DUPLEX-AD proof-of-concept study to compare JNJ-95475939 (JNJ-5939) to placebo in 240 people with moderate-to-severe atopic dermatitis. J&J began the trial in late February 2025 to validate signs of efficacy that persuaded it to pay Numab Therapeutics $1.25 billion upfront for the asset in 2024. Ten months after starting the study, J&J said the results of a planned interim analysis met prespecified criteria for early termination of the study. The termination reflected the asset’s failure to meet the “high-bar efficacy” that J&J has set for its atopic dermatitis programs, the company said in statement on Dec. 26. J&J, which is yet to share data from the trial, bet that JNJ-5939’s dual mechanism of action could improve on the standalone efficacy of two validated targets. The bispecific antibody targets IL-4 and IL-31, a pair of Type II cytokines. IL-4—which has become a cornerstone target in indications including atopic dermatitis because of its role in inflammation—is targeted by Regeneron and Sanofi’s blockbuster autoimmune disease drug Dupixent. David Lee, global immunology therapeutic area head at J&J, explained the rationale for targeting IL-31 at a conference in November. Lee called IL-31 “a big driver of itch,” adding that single-target drugs aimed at the cytokine have shown “some modest efficacy” in atopic dermatitis. The FDA approved Galderma’s anti-IL-31 antibody Nemluvio in atopic dermatitis in December 2024. John Reed, executive vice president for innovative medicine R&D at J&J, said at a Morgan Stanley event in September that JNJ-5939’s bispecific mechanism was an attempt to “break through efficacy ceilings of the monotherapies.” With JNJ-5939 failing to meet J&J’s expectations, the company’s focus in atopic dermatitis will shift to other assets. For now, JNJ-7528 is the only other atopic dermatitis candidate in J&J’s public pipeline. J&J began a Phase I trial of the asset in 2024 and is planning to start enrolling participants in a Phase IIb study next month. However, the company has other molecules cooking. J&J paid $850 million in May 2024 to buy Proteologix for its atopic dermatitis programs. That deal gave J&J control of a bispecific that hits IL-13 and TSLP, the target of Amgen and AstraZeneca’s Tezspire. J&J said the bispecific was ready to enter Phase I when it struck the deal. Lee said in November that the program was “progressing at pace, getting into the clinic.” The drugmaker also has an exclusive license to Kaken Pharmaceutical’s STAT6 program. J&J struck a deal for the oral drug candidate in late 2024 and, at that stag,e was aiming to enter the clinic in 2025.

Phase 1Phase 2License out/inDrug Approval

19 Dec 2025

·www.drugs.com

Eczema Injectable Drug Provides Quick Itch Relief, Clinical Trial Results Show

FRIDAY, Dec. 19, 2025 — A recently approved injectable eczema drug provides quick itch relief to patients with the maddening skin disease, a new study says. Nemolizumab ( Nemluvio ) relieved itchiness within two days for three times as many patients as a placebo, researchers reported Dec. 16 in the Journal of the European Academy of Dermatology and Venereology . The drug also helped twice as many eczema patients sleep better within a couple of days, researchers said. “These new data reinforce our understanding of nemolizumab’s rapid onset of action in relieving itch and, in turn, improving sleep in patients living with atopic dermatitis and prurigo nodularis,” researcher Dr. Christophe Piketty said in a news release. He’s program head of therapeutic dermatology for the Swiss pharma company Galderma. Galderma, the developer of nemolizumab, funded the study. The U.S. Food and Drug Administration (FDA) approved nemolizumab in 2024 for treatment of moderate-to-severe atopic dermatitis, commonly known as eczema, as well as for itchy bumps that often appear alongside eczema in a condition called prurigo nodularis, according to Drugs.com . Eczema occurs due to immune system problems that hamper the skin’s defenses against allergens and irritants, the Cleveland Clinic says. A monoclonal antibody, nemolizumab targets a receptor which activates an inflammatory immune system chemical that drives itch and other symptoms in eczema, researchers said in background notes. For the new study, researchers performed a follow-up analysis of the clinical trial data that led to FDA approval of the drug. They reviewed data from trials involving nearly 2,300 people. Results showed that nemolizumab reduced itch within 48 hours for nearly 11% of patients, compared to 3% of patients taking a placebo. It also reduced itch that swiftly for 17% of patients with prurigo nodularis, compared to just under 4% of those on placebo. Sleep also improved within two days for 10% of eczema patients on nemolizumab compared to under 5% of those on a placebo, and more than 13% of prurigo nodularis patients compared to about 4% of those on placebo. By two weeks, a quarter of patients with eczema and more than a third with prurigo nodularis had shown clinically meaningful improvements in itch and sleep, the study said. “Itch is the most burdensome symptom reported by patients with moderate-to-severe atopic dermatitis and patients with prurigo nodularis, and rapid improvement in itch intensity is a key treatment goal,” researchers concluded. “Treatments that rapidly reduce itch and provide clinically meaningful improvements in disease severity and patients' quality of life are key in the current treatment landscape for both AD and PN,” they wrote. Sources Galderma, news release, Dec. 17, 2025 Journal of the European Academy of Dermatology and Venereology, Dec. 16, 2025

Clinical ResultDrug Approval

100 Deals associated with Nemolizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11080	Nemolizumab	-	DB15252

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Moderate Atopic Dermatitis	United States	Galderma Laboratories LP	13 Dec 2024
Severe Atopic Dermatitis	United States	Galderma Laboratories LP	13 Dec 2024
prurigo nodularis	Japan	Maruho Co., Ltd.	26 Mar 2024
Dermatitis, Atopic	Japan	Maruho Co., Ltd.	28 Mar 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pruritus	Phase 3	United States	Galderma Holding SA	29 Dec 2021
Pruritus	Phase 3	Hungary	Galderma Holding SA	29 Dec 2021
Pruritus	Phase 3	Poland	Galderma Holding SA	29 Dec 2021
Pruritus	Phase 3	Spain	Galderma Holding SA	29 Dec 2021
CREST Syndrome	Phase 2	-	GALDERMA PHARMA SA	15 Dec 2025
Scleroderma, Diffuse	Phase 2	-	GALDERMA PHARMA SA	15 Dec 2025
Scleroderma, Systemic	Phase 2	Japan	Maruho Co., Ltd.	20 Apr 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04204616 (OLYMPIA LTE, Pubmed \| J Eur Acad Dermatol Venereol)	Phase 3	prurigo nodularis	508	Nemolizumab	uxghsorlaj(tcsgmwsvme) = zfixcorrtk scsbpbagaa (rbaqxlljup ) View more	Positive	17 Dec 2025
NCT03989206 (ARCADIA LTE, Pubmed \| J Eur Acad Dermatol Venereol)	Phase 2/3	Dermatitis, Atopic	1,062	Nemolizumab	qefqzdviyx(xdhgfjyhyf) = The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab. The most common (≥5.0%) TEAEs were COVID-19 (19.6%), nasopharyngitis (19.5%), atopic dermatitis (18.1%), upper respiratory tract infection (12.7%), headache (6.5%) and asthma (5.5%). epzlllzhnm (hfrlhewogn )	Positive	13 Oct 2025
				Placebo
NCT04365387 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	242	Nemolizumab (Nemolizumab)	mjzxhywcok = crwnldagfx ycrgmotgfr (qtgcbusknv, nxpcjymzpq - gioxhzjazg) View more	-	05 Jun 2025
				Placebo (Placebo)	mjzxhywcok = hxokrjhjqd ycrgmotgfr (qtgcbusknv, hdahspxpea - hkzembcfgg) View more
NCT03985943 (ARCADIA, Pubmed \| Patient)	Phase 3	Dermatitis, Atopic	73	Nemolizumab	clyevztsaa(hvmafbdkrr) = lbvyrprveq wwjmlcyiee (nkqhkphdsj ) View more	-	13 May 2025
				Placebo	clyevztsaa(hvmafbdkrr) = ylscwrsazx wwjmlcyiee (nkqhkphdsj ) View more
NCT05075408 (NIKAIA 1, CTgov)	Phase 2/3	Pruritus	258	Nemolizumab (Nemolizumab 30 mg)	jumlwjnmxl = lsuqehujjc fzxdmhdxby (nzlbjxpksw, ccbqovfhch - hduaohlfau) View more	-	20 Feb 2025
				Nemolizumab (Nemolizumab 60 mg)	jumlwjnmxl = tyvzwgedsi fzxdmhdxby (nzlbjxpksw, bbxnwndvkw - sndslrovrw) View more
NCT05405985 (CTgov)	Phase 1	-	192	Nemolizumab (Nemolizumab With AI)	sdlbjmmkth(pmwxdceedk) = hcubpcdpdd lululqtuct (zmsaznewoq, 2.34) View more	-	03 Jan 2025
				DCS+Nemolizumab (Nemolizumab With DCS)	sdlbjmmkth(pmwxdceedk) = bazxmejcoc lululqtuct (zmsaznewoq, 2.31) View more
NCT04562116 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	17	CYP 450 Substrates+Nemolizumab	lanlvxsmqg = lztlinssrn spcpcbynji (rhwvwgcnwc, qewgefgtal - ccibhjnhbg) View more	-	05 Dec 2024
JPRN-jRCT2080225289 (Pubmed)	-	Dermatitis, Atopic	89	尼莫利珠单抗	oyitihoazj(yjnyqcnkni) = nsntjbzqpw qhudieipro (mnedrxqaue ) View more	Positive	28 Nov 2024
				安慰剂	oyitihoazj(yjnyqcnkni) = gtxvukevje qhudieipro (mnedrxqaue ) View more
NCT04501666 (OLYMPIA 1, Pubmed \| JAMA Dermatol)	Phase 3	prurigo nodularis	286	Nemolizumab 30 mg	fadqbvoamw(onkgyniuot) = jdnzngmcju snylhgknyq (ksqxjitcne, 6.7% - 22.6%) View more	Positive	27 Nov 2024
				Placebo	fadqbvoamw(onkgyniuot) = hawsfkeuvr snylhgknyq (ksqxjitcne ) View more
NCT05052983 (CTgov)	Phase 3	prurigo nodularis	34	Nemolizumab (Nemolizumab)	ovknmlfxmd(bpzvqlcmtu) = srfckhfexr cmjjsutcbk (fmmjjsaaqp, mvbgqzbxxm - tciiuvvedv) View more	-	08 Oct 2024
				Placebo (Placebo)	ovknmlfxmd(bpzvqlcmtu) = wmrnhlyfec cmjjsutcbk (fmmjjsaaqp, cnhkvfuagu - bamwbvthhk) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis