Moderate-to-severe Atopic DermatitisPhase 2NCT05671432
The Study of CM326 in Moderate-to-severe Atopic Dermatitis
A Phase 2 study testing CM326 in people with Moderate-to-severe 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 study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Moderate-to-severe Atopic Dermatitis
- What is being tested?
- CM326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2022to 30 Dec 2024
- 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
- With confirmed Atopic Dermatitis (AD) at the screening.
- Age ≥ 18 years and ≤ 75 years, male or female.
- Have the ability to understand the nature of the study and voluntarily sign the informed consent.
- Be able to communicate well with investigators and follow up protocol requirements.
Who cannot join
- Not enough washing-out period for previous therapy.
- Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
- Major surgery is planned during the study period.
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's hospital
Beijing
Jianzhong Zhang
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM326 Injection in the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis
This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.
Read the detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Being tested
- CM326, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM326Biological
CM326 injection
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: CM326, subcutaneous (SC) Receives: Biological: CM326 |
| Group B | Experimental | Group A: CM326, subcutaneous (SC) Receives: Biological: CM326 |
| Group C | Placebo comparator | Group C: placebo, subcutaneous (SC) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Measured: at week 16
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16
IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe)
Measured: at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start27 Dec 2022 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
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
- NCT05671432
- Sponsor's protocol ID
- CM326-101102
- Status last verified
- Dec 2022
- First submitted
- 26 Dec 2022
- Last updated
- 4 Jan 2023
- Results posted
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM326 Injection in the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT05671432
- Acronym / sponsor ID
- CM326-101102
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2022 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 4 Jan 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, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.
Detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: CM326Group A: CM326, subcutaneous (SC) |
| Group B | Experimental | Biological: CM326Group A: CM326, subcutaneous (SC) |
| Group C | Placebo comparator | Other: PlaceboGroup C: placebo, subcutaneous (SC) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- With confirmed Atopic Dermatitis (AD) at the screening.
- Age ≥ 18 years and ≤ 75 years, male or female.
- Have the ability to understand the nature of the study and voluntarily sign the informed consent.
- Be able to communicate well with investigators and follow up protocol requirements.
Key exclusion criteria (4 listed)
- Not enough washing-out period for previous therapy.
- Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline.
- Major surgery is planned during the study period.
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the 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 |
|---|---|---|
| CM326CM326 injection | Biological | Group A, Group B |
| PlaceboPlacebo | Other | Group C |
Primary outcome
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16
Time frame: at week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16
Time frame: at week 16
IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- 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.
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 CM326 in people with Moderate-to-severe 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 4 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: status not confirmed, as of the sponsor's last update on 4 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Jia (+862888610620, qianjia@keymedbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16 (time frame: at week 16). 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?
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 4 Jan 2023.