Atopic DermatitisPhase 1/2NCT06162507
Study of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatis
A Phase 1/2 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 study to evaluate safety in children patients with moderate-to severe atopic dermatis. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- CM310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2023to 4 Jul 2024
- Phase
- Phase 1/2
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- With atopic dermatis.
- Voluntarily sign the informed consent form.
Who cannot join
- Any major surgery planned during the research period.
- With intestinal parasitic infection within the first 6 months of screening.
- With any previous malignant tumors prior to screening.
- With any circumstance that 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, Pharmacokinetics, and Pharmacokinetics of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatitis
This is a multi-center, single arm, open-label study to evaluate safety in children patients with moderate-to severe atopic dermatis.
- 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
CM310 injection
| Study group | Role | What they receive |
|---|---|---|
| CM310 group A | Experimental | CM310 injection, subcutaneous injection, once every 3 weeks. Receives: Biological: CM310 |
| CM310 group B | Experimental | CM310 injection, subcutaneous injection, once every 2 weeks. 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 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start22 Dec 2023
- Primary completion4 Jul 2024
- Study completion4 Jul 2024
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162507
- Sponsor's protocol ID
- CM310-101010
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao M, Xu Z, Wu L, Wei Z, Yang B, Lin Z, Ding Y, Hu G, Wang H, Qian Q, Ran Q, Li X, Xu Y, Xu Y, Huang Y, Jia Y, Chen B, Ma L. Safety and efficacy of stapokibart, an anti-interleukin-4 receptor alpha monoclonal antibody, in children aged 6-11 years with moderate-to-severe atopic dermatitis: an open-label single-arm phase Ib/IIa trial. Br J Dermatol. 2026 Mar 19;194(4):621-628. doi: 10.1093/bjd/ljaf455.
PubMed 41284735
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. 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, Pharmacokinetics, and Pharmacokinetics of CM310 in Children Subjects With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06162507
- Acronym / sponsor ID
- CM310-101010
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2023 (actual)
- Primary completion
- 4 Jul 2024 (actual)
- Study completion
- 4 Jul 2024 (actual)
- First posted
- 8 Dec 2023 (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 study to evaluate safety in children patients with moderate-to severe atopic dermatis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CM310 group A | Experimental | Biological: CM310CM310 injection, subcutaneous injection, once every 3 weeks. |
| CM310 group B | Experimental | Biological: CM310CM310 injection, subcutaneous injection, once every 2 weeks. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- With atopic dermatis.
- Voluntarily sign the informed consent form.
Key exclusion criteria (4 listed)
- Any major surgery planned during the research period.
- With intestinal parasitic infection within the first 6 months of screening.
- With any previous malignant tumors prior to screening.
- With any circumstance that 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 |
|---|---|---|
| CM310CM310 injection | Biological | CM310 group A, CM310 group B |
Primary outcome
Adverse events
Time frame: up to week 16
Incidence of adverse events.
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 15 Oct 2024.
- Derived from this study: PubMed 41284735Zhao M, Xu Z, Wu L, Wei Z, Yang B, Lin Z, Ding Y, Hu G, Wang H, Qian Q, Ran Q, Li X, Xu Y, Xu Y, Huang Y, Jia Y, Chen B, Ma L. Safety and efficacy of stapokibart, an anti-interleukin-4 receptor alpha monoclonal antibody, in children aged 6-11 years with moderate-to-severe atopic dermatitis: an open-label single-arm phase Ib/IIa trial. Br J Dermatol. 2026 Mar 19;194(4):621-628. doi: 10.1093/bjd/ljaf455.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 4 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 15 Oct 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Adverse events (time frame: up to week 16). 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 NCT06162507, 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 15 Oct 2024.