Evaluating a new treatment for moderate to severe atopic dermatitis

A Multi-Centered, Randomized, Double-Blinded, Placebo-Controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) When Used In Combination With Topical Corticosteroid Treatment (TCS) in Participants With Moderate to Severe Atopic Dermatitis.

This study is testing a new treatment for people with moderate to severe atopic dermatitis to see if it works better when combined with standard creams than just using the creams alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Shanghai, Shanghai and 2 other locations)
• Trial ID: NCT06554847 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of a new treatment, referred to as 611, in combination with topical corticosteroids for patients suffering from moderate to severe atopic dermatitis. Participants will be randomly assigned to receive either the treatment or a placebo alongside standard corticosteroid therapy. The study aims to determine whether the addition of 611 can improve outcomes for patients who have not responded adequately to existing topical treatments.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a history of moderate to severe atopic dermatitis that has not responded well to topical medications.

Not a fit: Patients who have previously participated in a 611 clinical study or those with serious uncontrolled diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief and improved management for patients with moderate to severe atopic dermatitis.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in improving treatment outcomes for atopic dermatitis.

Eligibility criteria

Inclusion Criteria:

* Male or female adults ages 18 to 75 years old when signing the informed consent.
* AD (according to Hanifin-Rajka Criteria) that had been present for at least 1 years before the screening visit.
* Moderate to Severe Atopic Dermatitis.
* Recent history of inadequate response to treatment with topical medications.

Exclusion Criteria:

* Participation in a prior 611 clinical study.
* Treatment with the following prior to the baseline visit: 1) Systemic corticosteroid or Immunosuppressants / Immunomodulators within 4 weeks or within 5 half-lives (if known), whichever is longer. 2) Monoclonal antibody within 5 half-lives (if known) or 4 months, whichever is longer. 3) Cell-depleting within 6 months.
* Treatment with a live (attenuated) vaccine within 2 months of the baseline visit or planned during the study.
* Serious or Uncontrolled diseases that may affect the safety of participants during the study period or hinder their completion of the study.
* Evidence of active acute or chronic hepatitis.
* History of malignancy within 5 years before the screening visit or currently.
* Pregnant or breastfeeding women, or women planning to become pregnant.
* Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).

Where this trial is running

Shanghai, Shanghai and 2 other locations

• Shanghai Dermatology Hospital — Shanghai, Shanghai, China (Recruiting)
• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Qinghong Zhou

Conditions Dermatitis, Atopic; Eczema, Atopic