Moderate-to-severe Atopic DermatitisPhase 1/2NCT04893941
Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
A Phase 1/2 study testing CM310 in people with Moderate-to-severe Atopic Dermatitis, run by Keymed Biosciences Co.Ltd at 7 sites in China.
Trial summary
This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously 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
- 39 participants
- Where
- 7 sitesChina
- Study dates
- 21 Jul 2020to 22 Jan 2021
- 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 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
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University People's Hospital
Beijing
Peking University Third Hospital
Beijing
Second Xiangya Hospital of Central South University
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
Hangzhou First People's Hospital
Hangzhou, Zhejiang
Shanghai Skin Disease Hospital
Shanghai
Wuxi Second Hospital
Wuxi, Jiangsu
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Multiple Dose Escalation, Phase Ib/IIa Study to Evaluate the Safety, Tolerance, PK, PD, Immunogenicity and Preliminary Efficacy of Subcutaneously CM310 in Moderate-severe AD Subjects.
This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.
Read the detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Being tested
- CM310, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM310Drug
IL-4Rα monoclonal antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CM310 75mg arm | Experimental | 75mg for 3 doses, every 2 weeks, SC Receives: Drug: CM310 |
| CM310 150mg arm | Experimental | 150mg for 3 doses, every 2 weeks, SC Receives: Drug: CM310 |
| CM310 300mg arm | Experimental | 300mg for 3 doses, every 2 weeks, SC Receives: Drug: CM310 |
| CM310 600(1st)+300mg(2nd,3rd) arm | Experimental | 600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC Receives: Drug: CM310 |
| placebo arm | Placebo comparator | placebo for 3 doses, every 2 weeks, SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)
Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: Baseline to Week 12
Secondary outcomes (14)
Pharmacokinetics parameter: Peak concentration (Cmax)
Peak concentration (Cmax)
Measured: Baseline to Week 12
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Measured: Baseline to Week 12
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Measured: Baseline to Week 12
Pharmacokinetics parameter: Clearance rate (CL/F)
Clearance rate (CL/F)
Measured: Baseline to Week 12
Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)
Serum Thymus and activation regulated chemokine (TARC), total IgE level and blood eosinophil count (EOS)
Measured: Baseline to Week 12
Pharmacodynamics parameters: Blood eosinophil count (EOS)
Blood eosinophil count (EOS)
Measured: Baseline to Week 12
Pharmacodynamics parameters: Total IgE level
Total IgE level
Measured: Baseline to Week 12
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)
Proportion of Participants with anti-drug antibody (ADA)
Measured: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with IGA 0 or 1
Proportion of subjects with Investigator's Global Assessment (IGA, on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) 0 or 1
Measured: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points
Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points
Measured: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points
Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points
Measured: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with EASI-50
Proportion of subjects with The Eczema Area and Severity Index(EASI)-50 (≥50 percent improvement from baseline)
Measured: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with EASI-75
Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
Measured: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline
Proportion of subjects with improvement (reduction) of pruritus Numerical Rating Scale(NRS) from baseline; The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start21 Jul 2020
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 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
- NCT04893941
- Sponsor's protocol ID
- CM310AD001
- Status last verified
- Jun 2021
- First submitted
- 25 Apr 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang L, Zhang W, Xu Y, Dong L, Sun Y, Jia Y, Li Z, Chen B, Hou J, Zhang J. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis. Adv Ther. 2024 Jul;41(7):2953-2965. doi: 10.1007/s12325-024-02887-w. Epub 2024 Jun 4.
PubMed 38833140
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Multiple Dose Escalation, Phase Ib/IIa Study to Evaluate the Safety, Tolerance, PK, PD, Immunogenicity and Preliminary Efficacy of Subcutaneously CM310 in Moderate-severe AD Subjects.
- ClinicalTrials.gov ID
- NCT04893941
- Acronym / sponsor ID
- CM310AD001
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 20 May 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 multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of subcutaneously CM310 in moderate-severe AD subjects.
Detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 4-week randomized Treatment Period and a 8-week Safety Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CM310 75mg arm | Experimental | Drug: CM31075mg for 3 doses, every 2 weeks, SC |
| CM310 150mg arm | Experimental | Drug: CM310150mg for 3 doses, every 2 weeks, SC |
| CM310 300mg arm | Experimental | Drug: CM310300mg for 3 doses, every 2 weeks, SC |
| CM310 600(1st)+300mg(2nd,3rd) arm | Experimental | Drug: CM310600mg for 1st dose, and then 300 mg for 2nd and 3rd doses, every 2 weeks, SC |
| placebo arm | Placebo comparator | Drug: Placeboplacebo for 3 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 | Drug | CM310 150mg arm, CM310 300mg arm, CM310 600(1st)+300mg(2nd,3rd) arm, CM310 75mg arm |
| PlaceboPlacebo | Drug | placebo arm |
Primary outcome
Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)
Time frame: Baseline to Week 12
Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
14 secondary outcomes
Pharmacokinetics parameter: Peak concentration (Cmax)
Time frame: Baseline to Week 12
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Time frame: Baseline to Week 12
Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Time frame: Baseline to Week 12
Pharmacokinetics parameter: Clearance rate (CL/F)
Time frame: Baseline to Week 12
Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)
Time frame: Baseline to Week 12
Pharmacodynamics parameters: Blood eosinophil count (EOS)
Time frame: Baseline to Week 12
Pharmacodynamics parameters: Total IgE level
Time frame: Baseline to Week 12
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with IGA 0 or 1
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with EASI-50
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with EASI-75
Time frame: Baseline to Week 12
Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline
Time frame: Baseline to Week 12
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 4 Jun 2021.
- Derived from this study: PubMed 38833140Zhang L, Zhang W, Xu Y, Dong L, Sun Y, Jia Y, Li Z, Chen B, Hou J, Zhang J. Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Stapokibart in Healthy Volunteers and Adult Subjects with Atopic Dermatitis. Adv Ther. 2024 Jul;41(7):2953-2965. doi: 10.1007/s12325-024-02887-w. Epub 2024 Jun 4.
- 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.
7 sites 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 Moderate-to-severe Atopic Dermatitis, run by Keymed Biosciences Co.Ltd at 7 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 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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?
Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing) (time frame: Baseline to Week 12). 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 NCT04893941, 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 4 Jun 2021.