Evaluation of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) in Chinese Adults With Moderate to Severe Atopic Dermatitis
China519 participantsStarted 2024-01-22
Plain-language summary
The primary objective of the study was to evaluate the efficacy of 611 in Chinese adults with moderate to severe atopic dermatitis.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject must be able to understand and comply with the requirements of the study. and must participate voluntarily and sign the written informed consent.
✓. 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.
✓. Eczema Area and Severity Index (EASI) score greater than or equal to (\>=) 16 at the screening and baseline visits.
✓. Investigator's Global Assessment (IGA) score \>=3 (on the 0 to 4 IGA scale, in which 3 was moderate and 4 was severe) at the screening and baseline visits.
✓. Participants with \>=10 percent (%) body surface area (BSA) of AD involvement at the screening and baseline visits.
✓. Baseline Pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity \>=4.
✓. Recent history (within 12 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments were otherwise medically inadvisable (e.g., because of important side effects or safety risks).
Exclusion criteria
✕. Presence of skin comorbidities that may interfere with study assessments
✕. Presence of active endoparasitic infections; or suspected endoparasitic.
✕. Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
What they're measuring
1
Number of Participants with Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
Timeframe: Baseline, Week 16
2
Number of Participants with Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to Week 16
✕. History of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix at least 1 year, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin at least 1 year.
✕. Active chronic or acute infection requiring treatment with systemic anti-infective therapy within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit.
✕. Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution: or unusually frequent infections, per investigator judgment.
✕. Active TB, unless that was well documented that the participants had adequately treated.
✕. Any medical condition that, in the opinion of the investigator, is serious or unstable and may affect the subject's safety and/or prevent the subject from completing the study