CompletedPhase 3

A Study to Evaluate the Efficacy and Safety of SIM0718 in Adult and Adolescent Patients With Moderate to Severe Atopic Dermatitis

China259 participantsStarted 2024-07-04

Plain-language summary

This study will evaluate the efficacy and safety of SIM0718 in adolescents (12- \< 18 years) and adults (18-75 years) with moderate to severe AD.

Age range12 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 12 and ≤ 75 years, male or female, and body weight ≥ 40 kg at the screening visit.
✓. Diagnosis of atopic dermatitis at screening (according to the American Academy of Dermatology Concordance Criteria, 2014), and: 1) Adult diagnosed AD for ≥ 12 months and adolescent diagnosed AD for ≥ 6 months prior to screening; 2) Inadequate response or intolerance to topical medications, or is medically inappropriate for topical treatment judged by the investigator within 6 months prior to Screening; 3) At Screening and Baseline,IGA score ≥3; 4)At Screening and Baseline, EASI score ≥ 16; 5) At Screening and Baseline,total AD involvement ≥ 10% BSA; 6) Baseline peak pruritus NRS score ≥ 4.

EASI-75 at week 16

Timeframe: Day1-Week16

IGA score at week 16

Timeframe: Day1-Week16

NCT IDNCT06477835

SponsorSimcere Pharmaceutical Co., Ltd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-04