RecruitingAtopic Dermatitis
A Clinical Study to Evaluate SM17 for Atopic Dermatitis
Eligible age
18–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: SinoMab BioScience Ltd
You may qualify if…
- ✓ Participants must meet all of the following inclusion criteria to be eligible for study participation:
- ✓ 1. Willing to sign the informed consent form (ICF), comply with the study procedures, and receive follow-up at the time points required in the protocol.
- ✓ 2. Able to understand and complete the study-related questionnaires by themselves or with the assistance of their caregiver/support.
- ✓ 3. Male or female, aged 18 to 70 years (inclusive) at the time of signing the ICF.
- ✓ 4. Meets the diagnostic criteria for AD (as defined by the Hanifin \& Rajka criteria) during the screening period, and had a history of AD or eczema for at least 1 year before the screening.
- ✓ 5. Has an EASI score of ≥16 at screening and baseline.
- ✓ 6. Has an Investigator's Global Assessment (IGA) score of ≥3 (on the basis of the 4 point vIGA-AD scale) at screening and baseline.
- ✓ 7. A body surface area (BSA) of AD involvement ≥10% at screening and baseline.
You may not qualify if…
- ✕ Participants who meet any of the following criteria will not be enrolled in the study:
- ✕ 1. Those with general conditions:
- ✕ 1. Female participants who are pregnant (pregnancy is defined as the state from conception until the termination of pregnancy), lactating, or have a positive serum human chorionic gonadotropin test result;
- ✕ 2. Alcohol abuse (ie, an average weekly consumption of \>14 units of alcohol \[1 unit ≈ 360 mL of beer or 45 mL of spirits with 40% alcohol content or 150 mL of wine\]) and/or drug abuse within half a year before screening;
- ✕ 2. Those who experience any of the following in laboratory tests and/or electrocardiogram (ECG) at screening or baseline (if necessary, a repeated test can be conducted for confirmation):
- ✕ 1. Hemoglobin \<100.0 g/L (males), or \<90.0 g/L (females);
- ✕ 2. White blood cell count \<3.0 × 109/L;
- ✕ 3. Neutrophil count \<1.5 × 109/L;
Source: ClinicalTrials.gov · NCT07445919 · last updated 2026-04-06