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Moderate-to-severe Atopic DermatitisPhase 2NCT04893707

The Study of CM310 in Patients With Atopic Dermatitis

A Phase 2 study testing CM310 in people with Moderate-to-severe Atopic Dermatitis, run by Keymed Biosciences Co.Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Moderate-to-severe Atopic Dermatitis
What is being tested?
CM310
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
1 siteChina
Study dates
7 Jun 2021to 3 Feb 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:
  • Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit.
  • Participation in CM310AD002 and met one of the following：i: Received study treatment and adequately completed the assessments and completed the EOS(V12) visit. ii:Treatment termination due to other reasons other than poor compliance or AE related to CM310 , completed the EOS visit .
  • Provide signed informed consent

Who cannot join

  • Patients who, during their participation in a previous CM310 clinical trial, developed a SAE/AE deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with CM310.
  • Not enough washing-out period for previous therapy.
  • Pregnancy.
  • Other

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University People's hospital

    Beijing

Other trials in China

About this study

Official title: An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis

This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).

Read the detailed description

The secondary objective of the study is to assess the immunogenicity of CM310 in patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Being tested
CM310
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

    Also called IL-4Rα monoclonal antibody

    adults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC.

    teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.

Study groups in NCT04893707
Study groupRoleWhat they receive
CM310Experimentaladults and teenagers (12 ~ 18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12 ~ 18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.
Receives: Biological: CM310

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Treatment Emergent Adverse Events (TEAEs)

    The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs

    Measured: Up to 2 Years

Secondary outcomes (20)

  1. Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI)

    Incidence and rate (events per patient-year) of SAEs and AESIs

    Measured: Up to 2 Years

  2. Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline of the parent study) at each visit

    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: Up to 2 Years

  3. Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit

    Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale [(a 6-point scale ranging from 0 (clear) to 5 (very severe)]

    Measured: Up to 2 Years

  4. Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline of the parent study) at each visit

    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: Up to 2 Years

  5. Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline of the parent study) at each visit

    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: Up to 2 Years

  6. Change from baseline in EASI score at each visit

    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: Up to 2 Years

  7. Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit

    IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)

    Measured: Up to 2 Years

  8. Proportion of patients with IGA reduction from baseline of ≥2 points at each visit

    IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe)

    Measured: Up to 2 Years

  9. Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline

    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: Up to 2 Years

  10. Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline

    The range of NRS is from 0 (no itch)-10 (worst imaginable itch)

    Measured: Up to 2 Years

  11. Percent change from baseline in NRS

    The range of NRS is from 0 (no itch)-10 (worst imaginable itch)

    Measured: Up to 2 Years

  12. Body Surface Area (BSA)

    Change from baseline in percent of BSA

    Measured: Up to 2 Years

  13. Time to first remission (achieving IGA = 0 or 1)

    Measured: Up to 2 Years

  14. Time to first relapse (eg, IGA >2) after remission or to not achieving remission

    Measured: Up to 2 Years

  15. Time to first EASI-50/75/90

    Measured: Up to 2 Years

  16. Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment

    Measured: Up to 2 Years

  17. Number of days on topical medication (per patient-year)

    Measured: Up to 2 Years

  18. Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI)

    The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) (Badia 1999). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL

    Measured: Up to 2 Years

  19. immunogenicity

    Detection of anti-drug antibody (ADA)

    Measured: Up to 2 Years

  20. Pharmacokinetics parameters

    trough concentration of CM310

    Measured: Up to 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start7 Jun 2021
  3. Primary completion3 Feb 2023
  4. Study completion3 Feb 2023

Resources

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
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893707
Sponsor's protocol ID
CM310AD100
Status last verified
Nov 2021
First submitted
15 May 2021
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao Y, Li JY, Yang B, Ding YF, Wu LM, Zhang LT, Wang JY, Lu QJ, Zhang CL, Zhang FR, Zhu XH, Li YM, Tao XH, Diao QC, Li LF, Lu JY, Man XY, Li FQ, Xia XJ, Song JR, Jia YM, Zhang LB, Chen B, Zhang JZ. Long-Term Efficacy and Safety of Stapokibart in Adults with Moderate-to-Severe Atopic Dermatitis: An Open-Label Extension, Nonrandomized Clinical Trial. BioDrugs. 2024 Sep;38(5):681-689. doi: 10.1007/s40259-024-00668-z. Epub 2024 Jul 31.

    PubMed 39080181

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 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: finished, as of the sponsor's last update on 8 Nov 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 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?

Number of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 2 Years). 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 NCT04893707, 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 8 Nov 2024.

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