Moderate-to-severe Atopic DermatitisPhase 2NCT04805411
Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
A Phase 2 study testing CM310 in people with Moderate-to-severe Atopic Dermatitis, run by Keymed Biosciences Co.Ltd at 25 sites in China.
Trial summary
This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Moderate-to-severe Atopic Dermatitis
- What is being tested?
- CM310
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 25 sitesChina
- Study dates
- 24 Feb 2021to 8 Nov 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
- Inadequate response to topical medications.
Who cannot join
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- pregnancy.
- Other.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Friendship Hospital，Capital Medical University
Beijing, Beijing Municipality
Peking University People's Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
First Hospital of Jilin University
Changchun, Jilin
Second Hospital of Jilin University
Changchun, Jilin
Second Xiangya Hospital of Central South University
Changsha, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
Chongqing Traditional Chinese Hospital
Chongqing, Chongqing Municipality
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong
Shandong Provincial Hospital of Dermatology
Jinan, Shandong
Ningbo Second Hospital
Ningbo, Zhejiang
Affiliated Hospital of Qingdao University
Qingdao, Shandong
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality
Wuxi Second Hospital
Wuxi, Jiangsu
Yantai Yuhuangding Hospital
Yantai, Shandong
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled Phase IIb Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week randomized Treatment Period and a 8-week Safety Follow-up Period.
Read the detailed description
Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Being tested
- CM310, Placebo
- Keywords
- Atopic dermatitis
- 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
IL-4Rα monoclonal antibody
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| High-dose arm | Experimental | 600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC Receives: Biological: CM310 |
| low-dose arm | Experimental | 300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC Receives: Biological: CM310 |
| placebo | Placebo comparator | placebo for 1-8 doses, every 2 weeks, SC Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EASI-75
Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
Measured: at Week 16
Secondary outcomes (12)
Investigator's Global Assessment (IGA) 0/1
Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points.
Measured: at week 16
reduction of IGA from baseline of ≥ 2 points
Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points.
Measured: at week 16
The Eczema Area and Severity Index (EASI)-90
Proportion of subjects with EASI-90 (≥90 percent improvement from baseline)
Measured: at week 16
The Eczema Area and Severity Index (EASI)-50
Proportion of subjects with EASI-50 (≥50 percent improvement from baseline)
Measured: at week 16
Improvement of Numerical Rating Scale (NRS)
Proportion of subjects with improvement (reduction) of pruritus NRS of ≥4 points from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch).
Measured: at week 16
Body Surface Area (BSA)
Change from baseline in percent of BSA
Measured: Baseline to Week 24
Dermatology Life Quality Index (DLQI)
Change from baseline in DLQI
Measured: Baseline to Week 24
Safety parameters
Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: Baseline to Week 24
Pharmacokinetics parameters
trough concentration and exposure of CM310
Measured: Baseline to Week 24
Pharmacodynamics
Serum Thymus and activation regulated chemokine (TARC)
Measured: Baseline to Week 24
Pharmacodynamics
Total IgE level
Measured: Baseline to Week 24
immunogenicity
Detection of anti-drug antibody (ADA)
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start24 Feb 2021
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
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
- 120 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
- NCT04805411
- Sponsor's protocol ID
- CM310AD002
- Status last verified
- Nov 2021
- First submitted
- 14 Mar 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled Phase IIb Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
- ClinicalTrials.gov ID
- NCT04805411
- Acronym / sponsor ID
- CM310AD002
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Keywords
- Atopic dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 18 Mar 2021 (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 IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week randomized Treatment Period and a 8-week Safety Follow-up Period.
Detailed description
Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.
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 |
|---|---|---|
| High-dose arm | Experimental | Biological: CM310600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC |
| low-dose arm | Experimental | Biological: CM310300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC |
| placebo | Placebo comparator | Biological: Placeboplacebo for 1-8 doses, every 2 weeks, SC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
- Inadequate response to topical medications.
Key exclusion criteria (5 listed)
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- pregnancy.
- Other.
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 |
|---|---|---|
| CM310IL-4Rα monoclonal antibody | Biological | High-dose arm, low-dose arm |
| PlaceboPlacebo | Biological | placebo |
Primary outcome
EASI-75
Time frame: at Week 16
Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
12 secondary outcomes
Investigator's Global Assessment (IGA) 0/1
Time frame: at week 16
reduction of IGA from baseline of ≥ 2 points
Time frame: at week 16
The Eczema Area and Severity Index (EASI)-90
Time frame: at week 16
The Eczema Area and Severity Index (EASI)-50
Time frame: at week 16
Improvement of Numerical Rating Scale (NRS)
Time frame: at week 16
Body Surface Area (BSA)
Time frame: Baseline to Week 24
Dermatology Life Quality Index (DLQI)
Time frame: Baseline to Week 24
Safety parameters
Time frame: Baseline to Week 24
Pharmacokinetics parameters
Time frame: Baseline to Week 24
Pharmacodynamics
Time frame: Baseline to Week 24
Pharmacodynamics
Time frame: Baseline to Week 24
immunogenicity
Time frame: Baseline to Week 24
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 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites 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 Moderate-to-severe Atopic Dermatitis, run by Keymed Biosciences Co.Ltd at 25 sites 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 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
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?
EASI-75 (time frame: at Week 16). 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 15 Apr 2022.