NCT07576608 A Phase II Study of 9MW3811 in Patients With Pathological Scar
| NCT ID | NCT07576608 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Mabwell (Shanghai) Bioscience Co., Ltd. |
| Condition | Scar |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-12-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-12-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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) * Provide written informed consent Exclusion Criteria: * 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 * Prior treatment with IL-11 cytokine or IL-6 family targeted therapy (e.g., tocilizumab) within specified washout periods * Participation in another interventional study within 28 days * Positive serology for HBV, HCV, HIV, or syphilis with clinical significance * History of severe allergy or known hypersensitivity to study drug components * Clinically significant laboratory abnormalities (eGFR \<90 mL/min/1.73m², PLT \<100×10⁹/L, QTc \>450/470 ms, bilirubin \>1.5×ULN, AST/ALT \>1.5×ULN) * Alcohol or drug abuse within 1 year * Pregnancy, breastfeeding, or unwillingness to use contraception * Any other condition that, in the investigator's judgment, would compromise subject safety or study compliance
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07576608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Scar. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07576608 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07576608 currently recruiting?
Yes, NCT07576608 is actively recruiting participants. Contact the research team at liecheng.yang@mabwell.com for enrollment information.
Where is the NCT07576608 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07576608 clinical trial?
NCT07576608 is sponsored by Mabwell (Shanghai) Bioscience Co., Ltd.. The trial plans to enroll 30 participants.