Atopic DermatitisPhase 2NCT06116565
A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis
A Phase 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, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 263 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2023to 26 Nov 2025
- Phase
- Phase 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Age ≥ 18 and ≤ 75 years old.
- With Atopic Dermatitis.
Who cannot join
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Major surgeries are planned during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis
This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.
Read the detailed description
The study consists of an screening period, treatment period, and safety follow-up period.
- 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, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CM310 | 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 (AEs)
Incidence of adverse events (AEs).
Measured: up to Week 60
Secondary outcomes (15)
Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit
Measured: up to Week 60
Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit
Measured: up to Week 60
Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit
Measured: up to Week 60
Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit
Measured: up to Week 60
Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Measured: up to Week 60
Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Measured: up to Week 60
Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Measured: up to Week 60
Percentage of subjects achieving a ≥4-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Measured: up to Week 60
Percentage of subjects achieving a ≥3-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Measured: up to Week 60
Change and percentage change from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Measured: up to Week 60
Change and percentage change from baseline in the body surface area (BSA) affected by atopic dermatitis (AD) at each scheduled assessment visit
Measured: up to Week 60
Change from baseline in Dermatology Life Quality Index (DLQI) score at each scheduled assessment visit
Measured: up to Week 60
Trough concentration (Ctrough) of CM310
Measured: up to Week 60
Incidence of treatment-emergent anti-drug antibodies (ADA)
Measured: up to Week 60
Incidence of neutralizing antibodies (NAb)
Measured: up to Week 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start21 Dec 2023
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 263 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
- NCT06116565
- Sponsor's protocol ID
- CM310-101116
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2023
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06116565
- Acronym / sponsor ID
- CM310-101116
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 3 Nov 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, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.
Detailed description
The study consists of an screening period, treatment period, and safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM310 | Experimental | Biological: CM310 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Age ≥ 18 and ≤ 75 years old.
- With Atopic Dermatitis.
Key exclusion criteria (3 listed)
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- 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 |
|---|---|---|
| CM310CM310, subcutaneous injection | Biological | CM310 |
Primary outcome
Adverse events (AEs)
Time frame: up to Week 60
Incidence of adverse events (AEs).
15 secondary outcomes
Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 0 at each scheduled assessment visit
Time frame: up to Week 60
Percentage of subjects achieving an Investigator's Global Assessment (IGA) score of 1 at each scheduled assessment visit
Time frame: up to Week 60
Percentage of subjects achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) at each scheduled assessment visit
Time frame: up to Week 60
Percentage of subjects achieving ≥90% improvement from baseline in the Eczema Area and Severity Index (EASI-90) at each scheduled assessment visit
Time frame: up to Week 60
Change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Time frame: up to Week 60
Percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Time frame: up to Week 60
Change and percentage change from baseline in Eczema Area and Severity Index (EASI) score at each scheduled assessment visit
Time frame: up to Week 60
Percentage of subjects achieving a ≥4-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Time frame: up to Week 60
Percentage of subjects achieving a ≥3-point reduction from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Time frame: up to Week 60
Change and percentage change from baseline in the weekly mean of daily Peak Pruritus Numerical Rating Scale (PP-NRS) scores
Time frame: up to Week 60
Change and percentage change from baseline in the body surface area (BSA) affected by atopic dermatitis (AD) at each scheduled assessment visit
Time frame: up to Week 60
Change from baseline in Dermatology Life Quality Index (DLQI) score at each scheduled assessment visit
Time frame: up to Week 60
Trough concentration (Ctrough) of CM310
Time frame: up to Week 60
Incidence of treatment-emergent anti-drug antibodies (ADA)
Time frame: up to Week 60
Incidence of neutralizing antibodies (NAb)
Time frame: up to Week 60
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 20 Aug 2026.
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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 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 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: finished, as of the sponsor's last update on 20 Aug 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. 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?
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 (AEs) (time frame: up to Week 60). 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 20 Aug 2026.