Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate SM17 Subcutaneous Injection for Moderate to Severe Atopic Dermatitis
Led by SinoMab BioScience Ltd · Updated on 2026-04-06
200
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SM17, a monoclonal antibody given by subcutaneous injection, for treating adults with moderate to severe atopic dermatitis who have not responded well or cannot tolerate certain topical treatments. This phase 2 clinical trial aims to study the effectiveness, safety, how the body processes the drug, and the immune response to SM17. The study also seeks to find the best dosing schedule for future research. Participants are randomly assigned to one of four groups receiving different doses of SM17 or a matching placebo. The treatment lasts 16 weeks during a double-blind phase, followed by an optional 4-week open-label period where all participants may receive SM17 depending on their skin condition scores. Dosages and intervals vary between groups, and participants receive subcutaneous injections throughout the study. After the treatment, a safety follow-up occurs 4 weeks after the last dose. During the study, participants will have regular assessments of their skin condition using clinical evaluations and patient questionnaires. Blood samples will be collected to monitor drug levels, immune response, and biomarkers. Safety tests, including lab work, will be performed regularly. The main outcome measured is the Eczema Area and Severity Index (EASI) at Week 16, with multiple other measures assessed at various timepoints up to Week 24. Total participation spans screening, treatment, and safety follow-up periods lasting several months.
CONDITIONS
Brief 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 follow study procedures
- Able to complete study questionnaires alone or with help
- Male or female, aged 18 to 70 years
- Diagnosed with atopic dermatitis by 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 affected by atopic dermatitis is 10% or more at screening and baseline
- Average maximum itch score of 4 or higher on Pruritus Numerical Rating Scale (PP-NRS) at baseline
- Recent inadequate response or intolerance to topical corticosteroids or calcineurin inhibitors
- Use of mild emollients at least twice daily for 7 days before randomization
- Agree to use effective contraception during the study and for 6 months after
You will not qualify if you...
- Pregnant, breastfeeding, or positive pregnancy test
- Alcohol or drug abuse within 6 months before screening
- Abnormal blood tests or ECG results as specified
- History of certain eye conditions or skin diseases that interfere with evaluation
- History of immunosuppressive diseases or frequent infections
- Active infections requiring systemic treatment within 2 weeks before screening
- Evidence of active or latent tuberculosis
- Diagnosis of lymphoma, leukemia, or recent malignancy within 5 years
- Significant medical diseases affecting study participation
- Allergies to SM17 or similar drugs
- Use of systemic corticosteroids, immunosuppressants, Janus kinase inhibitors, or certain other treatments within specified timeframes
- Use of prescription emollients containing 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 periods
- Receipt of live vaccines within 3 months before baseline or planned during study
- Participation in certain other clinical trials within 6 months before baseline
- Other conditions posing risk or interference as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive multiple subcutaneous doses of SM17 or placebo according to their assigned cohort to evaluate the efficacy and safety of SM17 for atopic dermatitis.
Weekly visits from Week 0 to Week 16
Duration - 4 weeks
Participants who choose to continue enter an open-label treatment period receiving SM17 with dosing depending on their condition at Week 16.
Visits during Weeks 16 to 20
Duration - 4 weeks
Participants undergo safety monitoring for 4 weeks after their last dose to assess any adverse events and overall health.
1 visit at 4 weeks after last dose
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
G
Guolin XU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here