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NCT Number: NCT06554847

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Dermatology Hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

611

Drug

subcutaneous injection

Placebo

Drug

subcutaneous injection

Topical Corticosteroid

Drug

Topical

Primary outcomes

  1. Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)

    Time frame: Baseline to Week 16

  2. Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16.

    Time frame: Baseline to Week 16

Secondary outcomes

  1. Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16

    Time frame: Baseline to Week 16

Sponsors and collaborators

Lead sponsor

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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