Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Sev… (NCT06554847) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Evaluation of 611 in Combination With Topical Corticosteroid in Participants With Moderate to Severe Atopic Dermatitis
China400 participantsStarted 2024-09-23
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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).
What they're measuring
1
Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score)
Timeframe: 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.