Atopic DermatitisPhase 3NCT06495229
Study of CM310 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, single arm, open label phase 3 study to evaluate the safety and efficacy 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?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2024to 30 Aug 2026
- Phase
- Phase 3
- 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 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).
- Subjects who must complete the evaluation of Week 18 of the main study.
- With Atopic Dermatitis.
Who cannot join
- Any major surgery planned during the research period.
- Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
- With any circumstance that the subject is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of CM310 in Adolescent Patients With Atopic Dermatitis
This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- CM310
- 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
| Study group | Role | What they receive |
|---|---|---|
| CM310 group | Experimental | Not described Receives: Biological: CM310 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence of adverse events.
Measured: up to week 52
Secondary outcomes (9)
Change from baseline in Eczema Area and Severity Index (EASI)
Changes from baseline in Eczema Area and Severity Index (EASI)
Measured: up to week 62
Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points
Proportion of subjects with IGA 0 or 1 (on a 5-point scale, range from 0-4 point, higher scores mean a worse disease severity) and reduction ≥2 points from baseline.
Measured: up to week 62
Improvement of Numerical Rating Scale (NRS)
Proportion of subjects with improvement (reduction) of pruritus NRS from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch).
Measured: up to week 62
Body surface area (BSA) of involvement of atopic dermatitis
Change from baseline in percent of BSA
Measured: up to week 62
Children Dermatology Life Quality Index (CDLQI)
Changes from baseline in CDLQI
Measured: up to week 62
Patient-Oriented Eczema Measure (POEM)
Changes from baseline in POEM
Measured: up to week 62
EuroQol Five Dimensions Questionnaire (EQ-5D)
Changes from baseline in EQ-5D
Measured: up to week 62
Pharmacokinetics parameters
Trough concentration and exposure of CM310
Measured: up to week 62
Immunogenicity
Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Measured: up to week 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start2 Aug 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
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
- NCT06495229
- Sponsor's protocol ID
- CM310-101215
- Status last verified
- Sep 2025
- First submitted
- 2 Jul 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of CM310 in Adolescent Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06495229
- Acronym / sponsor ID
- CM310-101215
- Conditions
- Atopic Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 10 Jul 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, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM310 group | Experimental | Biological: CM310 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Subjects who must complete the evaluation of Week 18 of the main study.
- With Atopic Dermatitis.
Key exclusion criteria (3 listed)
- Any major surgery planned during the research period.
- Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
- With any circumstance that the subject is not suitable to participate in this study.
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 |
Primary outcome
Adverse events
Time frame: up to week 52
Incidence of adverse events.
9 secondary outcomes
Change from baseline in Eczema Area and Severity Index (EASI)
Time frame: up to week 62
Proportion of subjects with Immunoglobulin A(IGA) 0 or 1 and a reduction of from baseline of ≥ 2 points
Time frame: up to week 62
Improvement of Numerical Rating Scale (NRS)
Time frame: up to week 62
Body surface area (BSA) of involvement of atopic dermatitis
Time frame: up to week 62
Children Dermatology Life Quality Index (CDLQI)
Time frame: up to week 62
Patient-Oriented Eczema Measure (POEM)
Time frame: up to week 62
EuroQol Five Dimensions Questionnaire (EQ-5D)
Time frame: up to week 62
Pharmacokinetics parameters
Time frame: up to week 62
Immunogenicity
Time frame: up to week 62
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 2 Oct 2025.
Related trials for Atopic Dermatitis
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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 3 inclusion and 3 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: under way, not looking for participants, 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. 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?
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?
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?
Adverse events (time frame: up to week 52). 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 2 Oct 2025.