ScarPhase 2NCT07576608
A Phase II Study of 9MW3811 in Patients With Pathological Scar
A Phase 2 study testing 9MW3811 Injection in people with Scar, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scar
- What is being tested?
- 9MW3811 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Tao Zan, Professor, MD, PhD, +86 13795204523, zantao@sjtu.edu.cn
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics Properties, and Preliminary Efficacy of 9MW3811 in Patients With Pathological Scar
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.
- Conditions
- Scar
- Being tested
- 9MW3811 Injection, Placebo
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW3811 InjectionDrug
9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously.
PlaceboDrug
Matching placebo solution with no active ingredient, administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 9MW3811 Injection (Low Dose) | Experimental | Intravenous infusion, multiple doses administered according to the protocol Receives: Drug: 9MW3811 Injection |
| 9MW3811 Injection (Middle Dose) | Experimental | Intravenous infusion, multiple doses administered according to the protocol Receives: Drug: 9MW3811 Injection |
| 9MW3811 Injection (High Dose) | Experimental | Intravenous infusion, multiple doses administered according to the protocol Receives: Drug: 9MW3811 Injection |
| Placebo | Placebo comparator | Intravenous infusion, matching placebo administered on the same schedule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in modified Vancouver Scar Scale (mVSS) score
There are 6 items in the mVSS scale (modified Vancouver Scar Scale), pigmentation, vascularity, pliability, thickness, pain, and itching. A total of 18 points, with minimum 0 indicating normal skin and maximum 18 indicating the most scarring and worst appearance. Change from baseline will be evaluated.
Measured: Up to Week 12
Assessment of adverse events (AE) / serious adverse events (SAEs)
Adverse Events occurring from ICF to last visit will be assessed and graded according to Common Terminology Criteria for Adverse Events version 6.0.
Measured: Up to Week 12
Number of participants with abnormal vital signs
Vital signs: include pulse, respiration, body temperature and blood pressure
Measured: Up to Week 12
Number of participants with abnormal Physical examination findings
Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
Measured: Up to Week 12
Number of participants with abnormal 12-lead ECG readings
12-lead ECG: HR, PR, QRS, QT, QTcF,
Measured: Up to Week 12
Number of participants with abnormal laboratory test results
Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
Measured: Up to Week 12
Secondary outcomes (11)
Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
POSAS includes observer scale (vascularity, pigmentation, thickness, relief, pliability, surface area) and patient scale (pain, itching, color, stiffness, thickness, irregularity). Lower scores indicate improvement.
Measured: Up to Week 12
Change from baseline in Dermatology Life Quality Index (DLQI) score
DLQI measures impact of skin disease on quality of life. Total score ranges 0-30; lower scores indicate better quality of life.
Measured: Up to Week 12
Maximum Plasma Concentration (Cmax)
To determine the pharmacokinetic (PK) of 9MW3811 following multiple intravenous infusions.
Measured: Up to Day 85
Time to reach Cmax (Tmax)
To determine the PK of 9MW3811 following multiple intravenous infusions.
Measured: Up to Day 85
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
To determine the PK of 9MW3811 following multiple intravenous infusions.
Measured: Up to Day 85
Terminal elimination half-life (t1/2)
To determine the PK of 9MW3811 following multiple intravenous infusions.
Measured: Up to Day 85
AUC from time 0 extrapolated to infinity (AUC0-inf)
To determine the PK of 9MW3811 following multiple intravenous infusions.
Measured: Up to Day 85
Terminal elimination rate constant (λz)
To determine the PK of 9MW3811 following multiple intravenous infusions.
Measured: Up to Day 85
Apparent clearance (CL)
To determine the PK of 9MW3811 following multiple intravenous infusions.
Measured: Up to Day 85
Volume of distribution (Vz)
To determine the PK of 9MW3811 following multiple intravenous infusions.
Measured: Up to Day 85
Immunogenicity: incidence of anti-drug antibodies (ADA)
Percentage of participants who develop detectable ADA against 9MW3811.
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start29 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576608
- Sponsor's protocol ID
- 9MW3811-CP201
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics Properties, and Preliminary Efficacy of 9MW3811 in Patients With Pathological Scar
- ClinicalTrials.gov ID
- NCT07576608
- Acronym / sponsor ID
- 9MW3811-CP201
- Conditions
- Scar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 9MW3811 Injection (Low Dose) | Experimental | Drug: 9MW3811 InjectionIntravenous infusion, multiple doses administered according to the protocol |
| 9MW3811 Injection (Middle Dose) | Experimental | Drug: 9MW3811 InjectionIntravenous infusion, multiple doses administered according to the protocol |
| 9MW3811 Injection (High Dose) | Experimental | Drug: 9MW3811 InjectionIntravenous infusion, multiple doses administered according to the protocol |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous infusion, matching placebo administered on the same schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 9MW3811 Injection9MW3811 is a recombinant humanized monoclonal antibody targeting interleukin-11 (IL-11). It is administered intravenously. | Drug | 9MW3811 Injection (High Dose), 9MW3811 Injection (Low Dose), 9MW3811 Injection (Middle Dose) |
| PlaceboMatching placebo solution with no active ingredient, administered intravenously. | Drug | Placebo |
Primary outcome
Change from baseline in modified Vancouver Scar Scale (mVSS) score
Time frame: Up to Week 12
There are 6 items in the mVSS scale (modified Vancouver Scar Scale), pigmentation, vascularity, pliability, thickness, pain, and itching. A total of 18 points, with minimum 0 indicating normal skin and maximum 18 indicating the most scarring and worst appearance. Change from baseline will be evaluated.
Assessment of adverse events (AE) / serious adverse events (SAEs)
Time frame: Up to Week 12
Adverse Events occurring from ICF to last visit will be assessed and graded according to Common Terminology Criteria for Adverse Events version 6.0.
Number of participants with abnormal vital signs
Time frame: Up to Week 12
Vital signs: include pulse, respiration, body temperature and blood pressure
Number of participants with abnormal Physical examination findings
Time frame: Up to Week 12
Physical examination: include height, weight, head and neck, mouth, chest, abdomen, lymph nodes, nerves and mind, limbs and other sites
Number of participants with abnormal 12-lead ECG readings
Time frame: Up to Week 12
12-lead ECG: HR, PR, QRS, QT, QTcF,
Number of participants with abnormal laboratory test results
Time frame: Up to Week 12
Laboratory tests: include blood routine examination, blood biochemistry, urine routine test and coagulation function
11 secondary outcomes
Change from baseline in Patient and Observer Scar Assessment Scale (POSAS) score
Time frame: Up to Week 12
Change from baseline in Dermatology Life Quality Index (DLQI) score
Time frame: Up to Week 12
Maximum Plasma Concentration (Cmax)
Time frame: Up to Day 85
Time to reach Cmax (Tmax)
Time frame: Up to Day 85
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: Up to Day 85
Terminal elimination half-life (t1/2)
Time frame: Up to Day 85
AUC from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Up to Day 85
Terminal elimination rate constant (λz)
Time frame: Up to Day 85
Apparent clearance (CL)
Time frame: Up to Day 85
Volume of distribution (Vz)
Time frame: Up to Day 85
Immunogenicity: incidence of anti-drug antibodies (ADA)
Time frame: Up to Day 85
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 9MW3811 Injection in people with Scar, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liecheng Yang (021-58585793, liecheng.yang@mabwell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in modified Vancouver Scar Scale (mVSS) score (time frame: Up to Week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.