Atopic DermatitisPhase 3NCT06277765
Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis
A Phase 3 study testing CM310 in people with Atopic Dermatitis, run by Keymed Biosciences Co.Ltd at 1 site in China.
Trial summary
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CM310
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2024to 23 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- With Atopic Dermatitis.
Who cannot join
- Not enough washing-out period for previous therapies.
- Any major surgery planned during the research period.
- With intestinal parasitic infection within the 6 months before screening.
- With any circumstance that is not suitable to participate in this study.
- Major surgeries are planned during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Adolescent Patients With Moderate-to-severe Atopic Dermatitis
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- CM310, placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM310Biological
Interleukin-4 receptor(IL-4Rα) monoclonal antibody
placeboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CM310 group | Experimental | Not described Receives: Biological: CM310 |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving EASI-75 at week 18
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).
Measured: Up to week 18
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline
Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 18. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Measured: up to week 18
Secondary outcomes (10)
Percent change of Eczema Area and Severity Index (EASI) score from baseline
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator on a scale of "0" (absent) through "3" (severe).
Measured: up to week 18
Percent change of NRS score from baseline
The range of Pruritus Numerical Rating Scale (NRS) is from 0 (no itch)-10 (worst imaginable itch)
Measured: up to week 18
Body surface area (BSA) of involvement of atopic dermatitis
Change from baseline in percent of BSA
Measured: up to week 18
Children Dermatology Life Quality Index (CDLQI)
Changes from baseline in CDLQI
Measured: up to week 18
Patient-Oriented Eczema Measure (POEM)
Changes from baseline in POEM
Measured: up to week 18
EuroQol Five Dimensions Questionnaire (EQ-5D)
Changes from baseline in EQ-5D
Measured: up to week 18
Safety parameters
Incidence of Adverse Event(AE), abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: up to week 26
Pharmacokinetics parameters
Trough concentration and exposure of CM310
Measured: up to week 26
Pharmacodynamics
Serum concentration of Thymus and activation regulated chemokine (TARC) , total immunoglobulin E (IgE) and lactate dehydrogenase (LDH)
Measured: up to week 26
Immunogenicity
Detection of anti-drug antibody (ADA)
Measured: up to week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start21 Mar 2024
- Primary completion23 Jan 2025
- Study completion23 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Keymed Biosciences Co.LtdThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jianzhong Zhang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277765
- Sponsor's protocol ID
- CM310-101212
- Status last verified
- Sep 2025
- First submitted
- 18 Feb 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou C, Zhao Y, Zhu G, Wu L, Liu Y, Tao X, Zhao H, Wei Z, Lu W, Li W, Ding Y, Zhu X, Hu G, Cheng H, Xiao R, Man XY, Wang Q, Li S, Zeng T, Wang L, Xu Y, Zhang L, Liu W, Zhao G, Jia Y, Huang Y, Chen B, Zhang J. Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial. Br J Dermatol. 2026 May 19;194(6):1067-1076. doi: 10.1093/bjd/ljag052.
PubMed 41697953
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of CM310 in Adolescent Patients With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06277765
- Acronym / sponsor ID
- CM310-101212
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 26 Feb 2024 (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 multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM310 group | Experimental | Biological: CM310 |
| Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- With Atopic Dermatitis.
Key exclusion criteria (5 listed)
- Not enough washing-out period for previous therapies.
- Any major surgery planned during the research period.
- With intestinal parasitic infection within the 6 months before screening.
- With any circumstance that is not suitable to participate in this study.
- Major surgeries are planned during the study period.
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 |
|---|---|---|
| CM310Interleukin-4 receptor(IL-4Rα) monoclonal antibody | Biological | CM310 group |
| placeboPlacebo | Other | Placebo |
Primary outcome
Proportion of subjects achieving EASI-75 at week 18
Time frame: Up to week 18
The EASI is a composite index with scores ranging from 0 to 72. Four AD disease characteristics (erythema, edema/papulation, excoriation, lichenification) will each be assessed for severity by the investigator on a scale of "0" (none) through "3" (severe).
Proportion of subjects with IGA score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline
Time frame: up to week 18
Proportion of subjects with Investigator's Global Assessment (IGA) score of 0 or 1 and a reduction of IGA score by ≥2 points from baseline at week 18. IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).
10 secondary outcomes
Percent change of Eczema Area and Severity Index (EASI) score from baseline
Time frame: up to week 18
Percent change of NRS score from baseline
Time frame: up to week 18
Body surface area (BSA) of involvement of atopic dermatitis
Time frame: up to week 18
Children Dermatology Life Quality Index (CDLQI)
Time frame: up to week 18
Patient-Oriented Eczema Measure (POEM)
Time frame: up to week 18
EuroQol Five Dimensions Questionnaire (EQ-5D)
Time frame: up to week 18
Safety parameters
Time frame: up to week 26
Pharmacokinetics parameters
Time frame: up to week 26
Pharmacodynamics
Time frame: up to week 26
Immunogenicity
Time frame: up to week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Derived from this study: PubMed 41697953Zhou C, Zhao Y, Zhu G, Wu L, Liu Y, Tao X, Zhao H, Wei Z, Lu W, Li W, Ding Y, Zhu X, Hu G, Cheng H, Xiao R, Man XY, Wang Q, Li S, Zeng T, Wang L, Xu Y, Zhang L, Liu W, Zhao G, Jia Y, Huang Y, Chen B, Zhang J. Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial. Br J Dermatol. 2026 May 19;194(6):1067-1076. doi: 10.1093/bjd/ljag052.
- 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. This study is not recruiting at the moment.
jianzhong Zhang principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CM310 in people with Atopic Dermatitis, run by Keymed Biosciences 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Oct 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects achieving EASI-75 at week 18 (time frame: Up to week 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06277765, which also lists 1 linked publication.
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 2 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.