A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Clinical Study to Evaluate the Efficacy and Safety of SM17 Monoclonal Antibody Injection (Subcutaneous Injection) in Participants With Moderate to Severe Atopic Dermatitis
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.
• Participants must meet all of the following inclusion criteria to be eligible for study participation:
• 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.
• Able to understand and complete the study-related questionnaires by themselves or with the assistance of their caregiver/support.
• Male or female, aged 18 to 70 years (inclusive) at the time of signing the ICF.
• 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.
• Has an EASI score of ≥16 at screening and baseline.
• Has an Investigator's Global Assessment (IGA) score of ≥3 (on the basis of the 4 point vIGA-AD scale) at screening and baseline.
• A body surface area (BSA) of AD involvement ≥10% at screening and baseline.
• A mean maximum pruritus intensity score of Pruritus Numerical Rating Scale (PP-NRS) ≥4 at baseline.
• Notes: The baseline pruritus NRS score for maximum pruritus intensity will be determined on the basis of the mean of daily NRS scores for maximum pruritus intensity (score range of 0 to 10) within 7 days before randomization. At least 4 daily scores within 7 days before randomization are required to calculate the baseline mean score. For participants who do not report at least 4 daily scores within 7 days before the scheduled randomization date, randomization should be postponed until this requirement is met, but not exceeding the maximum screening period of 28 days.
• Participants with a recent (within 6 months before the screening visit) medical history indicating that they have an inadequate response to topical medications or that the use of topical medications is medically inappropriate (eg, with important side effects or safety risks);
∙ Notes: Inadequate response is defined as failure to achieve or maintain disease remission or low disease activity (equivalent to IGA score of 0 \[= none\] to 2 \[= mild\]) even on a daily treatment regimen of moderate-to-strong topical corticosteroids (TCSs) (±topical calcineurin inhibitors \[TCIs\], if applicable) for at least 28 days or up to the maximum recommended course of treatment in the product prescription information (eg, 14 days for ultra-strong TCSs), whichever is shorter.
‣ Important side effects or safety risks are those that, as assessed by the investigator or the participant's attending physician, outweigh the potential benefit of treatment, including treatment intolerance, allergic reactions, significant skin atrophy, and systemic reactions.
⁃ Those who use topical mild emollients (moisturizers) at least twice daily for at least 7 consecutive days before randomization. For restrictions on the types of emollients not allowed during the study, see exclusion criterion 5.
⁃ Eligible participants of childbearing potential and their partners must agree to use a medically accepted contraceptive measure (eg, intra-uterine contraceptive device, anticonceptive or condom, or abstinence) during the study and for 6 months after the end of the study, with specific contraceptive measures detailed in the protocol; and have no plans to donate sperm/ova during the study and within 6 months after the end of the study.