Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis

Phase 3

Recruiting

• Conditions: Dermatitis, Atopic; Eczema, Atopic
• Interventions: Drug: 611; Drug: Placebo; Drug: Topical corticosteroid

• Registration Number: NCT06554847
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-15
• Study Start: 2024-09-23
• Last Update Submitted: 2024-09-29
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-10-12
• Study Completion: 2026-08-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
611 interval 1+Topical Corticosteroid	611	Participants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
611 interval 1+Topical Corticosteroid	Topical corticosteroid	Participants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
Placebo+Topical Corticosteroid	Topical corticosteroid	Participants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
611 interval 2+Topical Corticosteroid	611	Participants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
611 interval 2+Topical Corticosteroid	Topical corticosteroid	Participants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.
Placebo+Topical Corticosteroid	Placebo	Participants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.	Baseline to Week 16
Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)	Baseline to Week 16

Secondary Outcome Measures

Name	Time	Method
Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16	Baseline to Week 16

Trial Locations

Locations (3)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Shanghai Dermatology Hospital; 🇨🇳 Shanghai, Shanghai, China

The First Affiliated Hospital of Ningbo University; 🇨🇳 Ningbo, Zhejiang, China