A Phase II Study of 9MW3811 in Patients With Pathological Scar
ConditionScar
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMabwell (Shanghai) Bioscience Co., Ltd.
About this trial
This is a randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of 9MW3811 in patients with pathological scar.
Eligibility criteria
Qualifiers
Age ≥18 years
Pathological scar with no spontaneous regression over the prior 6 months
At least one scar with modified Vancouver Scar Scale (mVSS) score ≥9
Willing to use effective contraception for 6 months after last dose (if of childbearing potential)
Disqualifiers
Contracture scar causing deformity
All eligible scars either >10 cm in length and >5 cm in width, or located exclusively on sun-exposed areas (head, face, hands)
Evidence of scar infection or active systemic infection requiring treatment
Use of anti-scar medications (e.g., corticosteroids, immunosuppressants) or anti-scar procedures (surgery, laser, radiation, etc.) within 4 weeks prior to first dose
Trial design
Treatments tested in this trial
- 9MW3811 Injection
- Placebo
Treatment groups
30 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov