A Phase 1b, Open-label, Randomized, Multicenter, Active Comparator Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of the Combination of APG777 + APG990 in Adults With Moderate-to-Severe Atopic Dermatitis

The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic (PK) parameters of the combination of APG777 + APG990 in adults with moderate-to-severe atopic dermatitis (AD), in comparison to dupilumab. The duration of the study will be approximately 82 weeks for each participant and will consist of a Screening Period (up to 6 weeks), Treatment Period (Baseline-Week 24), and Follow-up Period (Week 28-Week 76).

Start Date04 Jun 2025

Sponsor / Collaborator

Apogee Therapeutics, Inc.

NCT07003425

/ RecruitingPhase 2

A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777

This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).
The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.
This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.

Start Date14 May 2025

Sponsor / Collaborator

Apogee Therapeutics, Inc.

NCT06920901

/ Active, not recruitingPhase 1

A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma.
The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.

Start Date27 Mar 2025

Sponsor / Collaborator

Apogee Therapeutics, Inc.

100 Clinical Results associated with Zumilokibart

100 Translational Medicine associated with Zumilokibart

100 Patents (Medical) associated with Zumilokibart

Literatures (Medical) associated with Zumilokibart

23 Mar 2026·Cureus Journal of Medical Science

Biologic Monotherapies for Moderate-to-Severe Atopic Dermatitis: A Systematic Review and Bayesian Network Meta-Analysis of Established and Investigational Agents

Review

Author: Babul, Najib ; Soliman, Yssra ; Babul, Arya ; Mehta, Devina ; Hussain, Momina

Biologic therapies targeting maladaptive type 2 inflammation have transformed the management of moderate‑to‑severe atopic dermatitis (AD); however, comparative evidence integrating both approved and next‑generation investigational agents remains limited. This Bayesian network meta‑analysis (BNMA) provides the first unified evaluation of all biologic monoclonal antibodies approved as monotherapy for AD (dupilumab, lebrikizumab, tralokinumab) together with emerging immunotherapies, including amlitelimab, rademikibart, rezpegaldesleukin, rocatinlimab, telazorlimab, temtokibart, and zumilokibart, across key efficacy measures. A PRISMA‑2020-compliant systematic review and PROSPERO‑registered protocol (CRD420251162704) identified phase 2-3 randomized, double‑blind, placebo‑controlled trials reporting week‑16 outcomes (week‑24 for rocatinlimab). A Bayesian random‑effects NMA estimated relative risks (RRs) for EASI‑75, EASI‑90, IGA‑AD 0/1, and ≥4‑point improvement in itch Numeric Rating Scale (NRS). Treatment hierarchy was evaluated using both Bayesian (SUCRA) and frequentist (P‑score) approaches. Seventeen randomized controlled trials (RCTs) involving more than 6,000 patients were included in the analysis. Dupilumab demonstrated the most consistent and reliable efficacy across all evaluated endpoints, including improvements in EASI-75, EASI-90, IGA-AD 0/1, and itch NRS. Among investigational therapies, rocatinlimab showed a notable signal for deep clinical responses, although the available evidence remains limited and less precise. Other emerging agents, including rademikibart, temtokibart, and zumilokibart, demonstrated encouraging efficacy profiles, whereas telazorlimab showed comparatively modest clinical benefit. Ranking analyses consistently positioned dupilumab as the most reliable and highest-performing therapy overall, followed by rocatinlimab. Overall, biologic therapies were generally well tolerated in the short term; however, dupilumab remains the only agent supported by extensive long-term safety data extending up to a decade. This analysis relied on indirect comparisons anchored to short‑term placebo‑controlled induction periods, limiting assessment of long‑term safety and durability, particularly for mechanistically distinct agents such as rezpegaldesleukin, a regulatory T cell (Treg) pathway agonist, and rocatinlimab, an OXO pathway inhibitor. Evidence for several emerging therapies was restricted to small phase 2 trials, resulting in wide credible intervals (Crls) and lower certainty in comparative rankings. Trial heterogeneity in baseline severity, ethnic composition, and geographic setting may have introduced residual confounding despite sensitivity and meta‑regression analyses. These factors should be considered when interpreting relative efficacy estimates This NMA demonstrates that dupilumab remains the most reliable and effective biologic monotherapy for moderate‑to‑severe AD, supported by the greatest precision, reproducibility, and long‑term safety. Rocatinlimab shows promising investigational efficacy but requires efficacy and long-term safety validation. Zumilokibart, rademikibart, and temtokibart emerge as additional candidates with encouraging activity, whereas telazorlimab showed limited clinical benefit. Collectively, these findings provide a comprehensive comparative framework to inform biologic selection and therapeutic sequencing.

01 Dec 2025·CTS-Clinical and Translational Science

A First‐in‐Human, Single‐ and Multiple‐Dose Study of APG777 , a Half‐Life‐Extended Anti‐ IL ‐13 Monoclonal Antibody, in Healthy Volunteers

Article

Author: Thankamony, Sai ; Winter, Erica ; Nograles, Kristine ; Zhang, Zhi‐Qiang ; Dambkowski, Carl L. ; Lim, Xiu Qin ; Dillinger, Lukas ; Xu, Jiahong

ABSTRACT:

Interleukin (IL)‐13 plays a central role in Type 2 inflammation, contributing to the pathogenesis of atopic dermatitis, asthma, and related inflammatory diseases. APG777 is a novel anti‐IL‐13 monoclonal antibody engineered for improved pharmacokinetics and reduced dosing frequency. This first‐in‐human, randomized, double‐blind, placebo‐controlled phase 1 study evaluated the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple subcutaneous doses of APG777 in healthy adults. Forty participants were enrolled in single ascending dose (300–1200 mg) and multiple dose (300 mg × 2) cohorts. APG777 was well tolerated, with only mild‐to‐moderate treatment‐emergent adverse events, predominantly unrelated to the study drug. No serious or severe drug‐related treatment‐emergent adverse events occurred. Following single doses, APG777 exhibited dose‐proportional increases in Cmax and area under the curve, with a terminal half‐life ranging from 75.3 to 77.5 days across the dose range tested. Immunogenicity was low, with anti‐drug antibodies detected in 23.3% of treated participants, generally without impact on pharmacokinetics or safety. APG777 led to rapid and durable inhibition of the IL‐13‐driven biomarkers phosphorylated signal transducer and activator of transcription 6 (pSTAT6), thymus and activation‐regulated chemokine (TARC), and immunoglobulin E (IgE), with near‐complete suppression of pSTAT6 observed for up to 12 months post‐dose. The safety and optimized pharmacokinetic profile of APG777 supports evaluation of extended dosing intervals (every 3–6 months) and higher exposures, which could improve outcomes and reduce injection burden in patients with Type 2 inflammatory diseases including atopic dermatitis and asthma.

01 Dec 2025·INTERNATIONAL JOURNAL OF TOXICOLOGY

Preclinical Safety of APG777, A Novel Extended Half-Life Anti-Interleukin-13 Monoclonal Antibody, in Cynomolgus Monkeys

Article

Author: Rubio, Daniel ; Badger, Drew ; Zhu, Eric ; Funk, Kathleen A. ; Thurston, Archie ; York, Kristina A. ; Dambkowski, Carl L.

Interleukin-13 (IL-13) is a cytokine implicated in the pathophysiology of type 2 inflammatory diseases and is a clinically validated target in atopic dermatitis. APG777 is a humanized IgG1 monoclonal antibody with an optimized pharmacokinetic profile. APG777 has high affinity to IL-13 and includes a triple amino acid modification (the “YTE” modification) in its Fc region that is designed to extend its half-life. The current study examined the safety and potential toxicity of APG777 when given by once-weekly subcutaneous injection for 27 weeks to cynomolgus monkeys, and the potential reversibility of any findings following a 2-month recovery period. Toxicokinetic characteristics of APG777 were also determined. APG777 exhibited dose-proportional systemic exposure, with a half-life of approximately 28 days. No APG777-related adverse effects were noted in clinical observations, body weight, ophthalmology, electrocardiogram readings, neurologic parameters, hematology, coagulation, clinical chemistry, urinalysis, organ weights, or histopathology. Anti-drug antibodies were not detected in any APG777-exposed animals. Drug accumulation was evident over the study duration; however, there were no APG777-related adverse findings in any of the parameters analyzed. The no-observed-adverse-effect level (NOAEL) was 150 mg/kg/week. These findings provide preclinical evidence supporting continued clinical development of APG777 for IL-13-mediated diseases. The extended half-life of APG777 suggests potential benefits in reducing dosing frequency compared with existing IL-13-targeting therapies, which could improve treatment adherence and patient outcomes. The safety and efficacy of APG777 are currently being investigated in a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe atopic dermatitis.

News (Medical) associated with Zumilokibart

13 Oct 2026

·www.fiercebiotech.com

Biotech builder Paragon imports Apogee's top brass after AbbVie buyout

It’s been a busy morning for Paragon Labs. In addition to installing several members of the former leadership team of AbbVie-acquired Apogee Therapeutics, Paragon has seen its hypertension-focused spinout Velaris Therapeutics enter the public markets through an acquisition by Nasdaq-listed Alaunos Therapeutics. Four months after AbbVie announced its $10.9 billion deal to buy Apogee for its late-phase eczema drug zumilokibart, it seems like Paragon has taken its pick of the biotech’s top talent. This includes Michael Henderson, M.D., who headed up Apogee until the sale and will now take up the same role at Paragon. Henderson will be joined at Paragon by his Apogee colleagues, namely head of R&D Carl Dambkowski, M.D., chief business and financial officer Dan Mulreany, chief legal officer Matt Batters and chief people officer Emily Cox. The Apogee alumni are no strangers to Paragon. In fact, zumilokibart was originally developed at Paragon before the Boston-based biotech drug discovery hub spun out Apogee to take the anti-IL-13 antibody forward. “At Apogee, we learned a tremendous amount about what it takes to translate Paragon-discovered programs into clinical-stage medicines,” Henderson said in an Oct. 13 release. “We now have an opportunity to apply those lessons to clinical development, regulatory strategy and execution from the very start, as Paragon's programs take shape,” the newly appointed CEO said. “That means bringing all of these insights to make decisions even earlier, so the companies that license Paragon's most promising assets can bring them to patients even faster,” Henderson added. Paragon was founded by life sciences investment firm Fairmount in 2021. As well as Apogee, Paragon has spun out biotechs like inflammatory bowel disease-focused Spyre Therapeutics and Oruka Therapeutics, whose long-acting plaque psoriasis candidate could pose a threat to AbbVie’s Skyrizi. Paragon had some other news to share about another one of its spinouts, Velaris Therapeutics, which has been acquired by Nasdaq-listed Alaunos Therapeutics. The combined company will be focused on Velaris’ pipeline of ActRIIA-Fc ligand traps and complementary biologics designed to address signaling imbalances that drive remodeling of blood vessels in the lungs in multiple cardiopulmonary conditions. These plans will be bankrolled by a $350 million private placement led by Fairmount, which is expected to fund the combined company into 2029. Velaris’ pipeline comes from Paragon and is headed up by VLR199, an ActRIIA-Fc ligand trap designed to improve on Merck & Co.’s activin signaling inhibitor Winrevair as a treatment for pulmonary arterial hypertension (PAH). Henderson, who has also been appointed president of Velaris, said the company aims to “transform the treatment of pulmonary hypertension, starting with PAH.” “We’ve built a capital-efficient plan to rapidly achieve proof-of-concept in PAH and demonstrate value,” Henderson added. “With a pipeline built to provide optionality around ligand traps, to address complementary signaling pathways, and to offer compelling follow-on opportunities beyond PAH, we are excited for this next chapter.”

Acquisition

01 Oct 2026

·www.biopharmadive.com

Pfizer’s eczema drug clears skin in mid-stage trial

An experimental eczema drug from Pfizer met its primary goal in a mid-stage clinical trial, achieving stronger skin clearance in significantly more people at multiple doses compared to a placebo after 16 weeks.According to detailed data from an ongoing Phase 2 trial shared at a European medical meeting Thursday, a substantially higher percentage of patients given Pfizers three-pronged antibody drug, tilrekimig, as opposed to a placebo experienced a 75% reduction in the scope and severity of their disease. The trial enrolled participants with moderate to severe atopic dermatitis, and the latest results build on data previously announced in March.Analysts described the findings as very strong and indicative that Pfizers drug could compete with already approved therapies like Eli Lillys Ebglyss and Sanofi and Regeneron Pharmaceuticals market-leading Dupixent. In a statement Thursday, Pfizer said it has pushed tilrekimig into advanced testing for asthma, chronic obstructive pulmonary disease and atopic dermatitis including a head-to-head trial against Dupixent.The compelling efficacy and tolerability demonstrated in this Phase 2 study validate this multi-pathway, trispecific approach and suggest that tilrekimig has the potential to raise the bar beyond current standard-of-care biologics, Michael Vincent, chief inflammation and immunology officer at Pfizer, said in that statement.Dupixent, a widely popular injection for autoimmune diseases, first entered the market for eczema in 2017. In the years since, it has been cleared for a range of inflammatory disorders and is a significant source of revenue for Sanofi and Regeneron, with net sales reaching almost $11 billion over the first six months of this year.But the megablockbuster is facing looming competition as key patent protections are set to expire in 2031. Additionally, several biotechnology companies and large pharmaceutical firms, such as Johnson and Johnson, AstraZeneca and Lilly, are working to create the next generation of anti-inflammatories medicines.Pfizer hopes to do the same. The pharma giant believes tilrekimig could become a new type of treatment that not only competes with, but surpasses the efficacy of drugs like Dupixent, while being a more convenient and potentially more durable option.The drug is a trispecific antibody that inhibits three proteins IL-4, IL-13 and TSLP, or thymic stromal lymphopoietin which are implicated in multiple immune diseases. By targeting the three proteins, Pfizer aims to provide broader coverage and deliver longer-lasting efficacy that can support a monthly dosing schedule.The Phase 2 trial evaluated, across two stages, tilrekimig in people who had never taken a biologic medicine for their disease. In the first stage, about 63% of trial participants who got 450 mg of tilrekimig every two weeks achieved whats known as EASI-75 compared to 20% in the placebo group.In the second stage, 48%, 61% and 57% of trial participants on 50 mg, 200 mg and 400 mg doses of the treatment every four weeks, respectively, achieved EASI-75 compared to 9% in the control arm. In a note to clients Thursday, RBC analyst Trung Huynh called the numbers impressive and competitive with rates seen with Dupixent and Ebglyss.A key secondary endpoint focused on whether a patients skin is clear or almost clear, and showed that, in Stage 1 of the trial, 30% of participants on that 450 mg dosing schedule achieved this mark versus almost 12% on placebo. In Stage 2, 26% to 27% of participants across the groups achieved it, whereas none of the placebo group did.Pfizer said tilrekimig was well-tolerated with no dose-dependent safety signals.Though the numbers are compelling, Huynh wrote that the competitive landscape continues to strengthen and quickly evolve, and, so far, Pfizers drug has shown minimal differentiation from Ebglyss and Abbvies antibody zumilokibart, which is in late-stage testing.Additionally, Huynh argued that its uncertain what TSLP targeting adds to the treatment of atopic dermatitis, so full Phase 3 data which are expected to come in 2028 will be needed to truly assess tilrekimigs commercial potential. '

Clinical ResultPhase 2Phase 3

30 Sep 2026

·www.prnewswire.com

AbbVie Highlights Positive Results from the Phase 2 APEX Part B Study of Zumilokibart in Moderate to Severe Atopic Dermatitis, as a Late Breaker at EADV 2026

Phase 2 data in adults with atopic dermatitis showed that all three zumilokibart dose regimens met the primary endpoint, with significantly greater improvements in Eczema Area and Severity Index -75 (EASI-75) response rates versus placebo at Week 16 1 The mid-dose regimen was selected for Phase 3 development, supporting further evaluation of the efficacy, safety and dosing profile of zumilokibart 1 Zumilokibart is a half-life extended monoclonal antibody targeting IL-13, in development for patients with atopic dermatitis 1 NORTH CHICAGO, Ill., Sept. 30, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the primary results from the ongoing Phase 2 APEX Part B Dose-Regimen-Finding Study, evaluating zumilokibart, in adult patients with moderate to severe atopic dermatitis (AD) will be presented as a late-breaker presentation at the 2026 Annual European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Sept. 30 – Oct. 3. APEX Part B is an ongoing randomized, double-blinded, placebo-controlled, Phase 2 dose-finding study in adults with moderate-to-severe AD. For this analysis, 346 participants were randomized 1:1:1:1 and received a low-, mid-, high-dose zumilokibart regimen or placebo during the 16-week induction period. The primary endpoint was the proportion of participants achieving at least a 75% improvement from baseline in EASI (EASI-75) at Week 16. The mid-dose regimen was identical to the induction regimen evaluated in APEX Part A. 1,2 At 16 weeks, all doses of zumilokibart demonstrated statistically significant improvements compared to placebo in skin lesions based on EASI 90/100 and itch based on I-NRS4: The mid- and high-dose regimens showed significantly greater improvement than placebo across key secondary endpoints, including near-complete or complete skin clearance based on EASI 90/100 and itch improvement based on I-NRS4. The mid-dose regimen achieved greater percent reductions versus placebo in skin severity (EASI) at Week 1 and in itch (I-NRS) at Week 2. The most common treatment-emergent adverse events through Week 16 (≥5% in any treatment group) were nasopharyngitis, headache, noninfective conjunctivitis, upper respiratory tract infection, atopic dermatitis, and urinary tract infection. "Despite significant advances in atopic dermatitis, there remains an unmet need for therapies that provide meaningful disease control with greater convenience for patients," said Kori Wallace, M.D., vice president, global head of immunology clinical development, AbbVie. "These results support the potential of zumilokibart to rapidly improve both skin and itch. Advancing the mid-dose regimen into Phase 3 and evaluating extended dosing intervals marks an important step in exploring a differentiated option for people living with AD." "Atopic dermatitis is a chronic disease, and the frequency of administration can be an important consideration when selecting a long-term therapy," said Melinda Gooderham, M.D., FRCPC, SKiN Centre for Dermatology and Queen's University, Ontario, Canada. "At Week 16, zumilokibart demonstrated improvements in skin clearance and itch. These findings support the further evaluation of zumilokibart as a long-term treatment for atopic dermatitis." Eczema Area and Severity Index (EASI) is a validated score that measures the severity of atopic dermatitis, ranging from 0 or clear skin to 72, indicating severe disease. EASI-75 at Week 16 is defined as achieving at least 75% improvement in lesion extent and severity from baseline on the EASI. Itch Numeric Rating Scale (I-NRS) is a patient reported outcome, rating itch on a 0 (no itch) to 10 (worst itch) scale. Additional information about the program can be found on clinicaltrials.gov under the identifier NCT07003425. EADV Presentation Details: About Zumilokibart Zumilokibart is a novel, high-affinity humanized IgG1 monoclonal antibody targeting interleukin-13 (IL-13) preventing the formation of the IL-13Rα1-IL4Rα heterodimer being investigated in AD. Zumilokibart is engineered for extended half-life, with clinical data demonstrating a half-life of approximately 77 days in humans. Zumilokibart is an investigational agent and is not approved by regulatory authorities. Safety and efficacy have not been established. About AbbVie in Immunology AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For more than 20 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology and dermatology, and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of action and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease. Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 20+ immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References: AbbVie. Data on file ABVRRTI84044 A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis. ClinicalTrials.gov. Available at: . Accessed September 24, 2026 SOURCE AbbVie 21% more press release views with Request a Demo

Clinical ResultPhase 3Phase 2Drug ApprovalImmunotherapy

100 Deals associated with Zumilokibart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Moderate Atopic Dermatitis	Phase 2	United States	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	Canada	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	Czechia	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	France	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	Germany	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	Hungary	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	Poland	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	Spain	Apogee Therapeutics, Inc.	29 Apr 2024
Moderate Atopic Dermatitis	Phase 2	United Kingdom	Apogee Therapeutics, Inc.	29 Apr 2024
Severe Atopic Dermatitis	Phase 2	United States	Apogee Therapeutics, Inc.	29 Apr 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06395948 (APXZP002, AAD2026)	Phase 2	Dermatitis, Atopic	123	APG777 (moderate AD (16≤EASI≤21 or vIGA-AD=3))	ziiccysvap(ponlahiwlm) = occurring in ≥5% of APG777-treated participants included noninfective conjunctivitis and upper respiratory tract infection fofgakriev (jynzxftitl )	Positive	27 Mar 2026
				APG777 (severe AD (EASI>21 or vIGA-AD=4))
NCT06395948 (APEX, AAD2026)	Phase 2	Dermatitis, Atopic	123	APG777	hlvbwalxxx(xmtkepamqf) = occurring in 6 5% of APG777-treated participants included noninfective conjunctivitis and upper respiratory tract infection. lfytujxrjb (luqcbqnkij ) View more	Positive	27 Mar 2026
				Placebo
NCT06395948 (APEX, Company_Website) Manual	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	-	Zumilokibart (APG777) 3-month dosing	ianenlrrmq(htdfnhwjtq) = annegujenr hxknqqqhbf (ztjotvwtky ) View more	Positive	23 Mar 2026
				Zumilokibart (APG777) 6-month dosing	ianenlrrmq(htdfnhwjtq) = fdmmknwblu hxknqqqhbf (ztjotvwtky ) View more
NCT06395948 (APEX Part A, AAAAI2026)	Phase 2	Dermatitis, Atopic	123	APG777 (with evidence of type 2 comorbidities)	ewqneelpia(csexzdupah) = fioxdgqglh zoovddyaog (lvgxlmajij )	Positive	27 Feb 2026
				Placebo (with evidence of type 2 comorbidities)	ewqneelpia(csexzdupah) = mkcaujhgky zoovddyaog (lvgxlmajij )
NCT06395948 (APEX Part A, AAAAI2026)	Phase 2	Dermatitis, Atopic	123	APG777	uyojvvfckz(zjfookcbbu): P-Value = <0.001 View more	Positive	27 Feb 2026
				Placebo
NCT06395948 (APEX, GlobeNewswire) Manual	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis \| Dermatitis	123	APG777	gyafkpcjza(aiegilnibw) = iluxswthcb nsxeadggut (jxhqojzkph ) Met View more	Positive	07 Jul 2025
				placebo	gyafkpcjza(aiegilnibw) = jurjzybdza nsxeadggut (jxhqojzkph ) Met View more
ACTRN12623000786695 (GlobeNewswire) Manual	Phase 1	-	40	APG777	gbpfgsofwp(xcfhahlvri) = hcxixllgfm dmgmuypzll (jsltozygna ) View more	Positive	05 Mar 2024
				placebo	-
NCT06395948 (APG777, EADV2023)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis IL-13	-	APG777	opcseaqhan(egrrzsjvcz) = ibmardjmff mopxiglgyb (nwykfmvoep )	Positive	11 Oct 2023
				Lebrikizumab	opcseaqhan(egrrzsjvcz) = mdmbwibezd mopxiglgyb (nwykfmvoep )

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