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

Sunshine Guojian Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Eczema, Atopic; Dermatitis, Atopic

Treatments: Drug: Topical corticosteroid; Drug: 611; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06554847

SSGJ-611-AD-III-02

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 3 patient groups, including a placebo group

611 interval 1+Topical Corticosteroid

Experimental group

Description:

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.

Treatment:

Drug: 611

Drug: Topical corticosteroid

611 interval 2+Topical Corticosteroid

Experimental group

Description:

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.

Treatment:

Drug: 611

Drug: Topical corticosteroid

Placebo+Topical Corticosteroid

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Topical corticosteroid