Actively Recruiting
A Clinical Study to Evaluate SM17 for Atopic Dermatitis
Led by SinoMab BioScience Ltd · Updated on 2026-04-06
200
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a phase 2, randomized, double-Blind, placebo-Controlled, dose-finding clinical study conducted in participants with moderate-to-severe atopic dermatitis. The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics , and pharmacodynamics of SM17 (subcutaneous injection) in participants with moderate to severe atopic dermatitis.
CONDITIONS
Official Title
A Clinical Study to Evaluate SM17 for Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign informed consent and comply with study procedures and follow-ups
- Able to understand and complete study questionnaires alone or with help
- Male or female aged 18 to 70 years at consent
- Diagnosed with atopic dermatitis per Hanifin & Rajka criteria with at least 1-year history
- Eczema Area and Severity Index (EASI) score of 16 or higher at screening and baseline
- Investigator's Global Assessment (IGA) score of 3 or higher at screening and baseline
- Body surface area (BSA) affected by AD is 10% or more at screening and baseline
- Average maximum itch intensity (Pruritus Numerical Rating Scale) of 4 or higher at baseline
- History within 6 months of inadequate response or intolerance to topical corticosteroids or calcineurin inhibitors
- Using mild emollients at least twice daily for 7 consecutive days before randomization
- Agree to use medically accepted contraception during the study and for 6 months after, and no plans to donate sperm or ova during this time
You will not qualify if you...
- Female participants who are pregnant, breastfeeding, or have positive pregnancy test
- Alcohol or drug abuse within 6 months before screening
- Abnormal lab results including low hemoglobin, low white blood cell or platelet counts, elevated liver enzymes, high bilirubin, or high serum creatinine
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis infections
- ECG abnormalities indicating serious heart conditions
- History of certain eye inflammations or skin diseases that interfere with AD diagnosis or evaluation
- Known or suspected immunosuppressive diseases or recurrent infections
- Active or recent infections needing systemic treatment within 2 weeks before screening
- Active or latent tuberculosis
- History of lymphoma, leukemia, or other cancers within 5 years except certain skin or cervical cancers fully treated
- Significant medical diseases affecting safety or study participation
- Allergy to SM17, monoclonal antibodies, or related severe drug allergies
- Use of systemic corticosteroids, immunosuppressants, Janus kinase inhibitors within 4 weeks before baseline
- Use of antihistamines or inhaled corticosteroids within 1 week before baseline unless stable and continued during study
- Recent use of systemic herbal therapy, ultraviolet therapies, or bleach baths before baseline
- Use of topical corticosteroids, calcineurin inhibitors, traditional Chinese medicine, or phosphodiesterase-4 inhibitors within 1 week before baseline
- Prior biologic treatments for AD within specified washout periods
- Prior allergen-specific immunotherapy within 6 months before baseline
- Use of prescription emollients with active ingredients within 1 week before baseline
- Major surgery within 3 months before baseline or planned during study
- Recent blood donation or transfusion within specified timeframes
- Recent live attenuated vaccine within 3 months before baseline or planned during study
- Participation in other interventional clinical studies within 6 months before baseline
- Prior participation in anti-IL-25 or anti-IL-17RB antibody clinical studies
- Other conditions judged by investigator as risk or interference for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
G
Guolin XU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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