Clinical trial NCT06554847: Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dermatitis, Atopic
Eczema, Atopic
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe 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).

Primary outcomes:
measure: Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)
timeFrame: Baseline to Week 16
measure: Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Hangzhou First People&#39;s Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: