Moderate-to-severe Atopic DermatitisPhase 1/2NCT05186922
The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis
A Phase 1/2 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 multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of CM326 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?
- CM326
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2022to Jan 2023
- 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
- With confirmed Atopic Dermatitis (AD) at least 12 months before the screening
- Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline
- Investigator's Global Assessment (IGA) score ≥3 at screening and baseline
- Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline
- The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
- Provide signed informed consent
Who cannot join
- Not enough washing-out period for previous therapy.
- Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
- Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN), total bilirubin >1.5 times of upper limit of normal (ULN) or serum creatinine level > upper limit of normal (ULN).
- Womens 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, Beijing Municipality
Jianzhong Zhang
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Multiple Dose Escalation, Phase 2 Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Moderate-severe Atopic Dermatitis 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 CM326 in moderate-severe AD subjects.
Read the detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week randomized Treatment Period and a 12-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 |
|---|---|---|
| CM326 55 mg, once every two weeks (Q2W) | Experimental | 55mg for 6 doses, every 2 weeks, subcutaneous (SC) Receives: Biological: CM326 |
| CM326 110 mg, once every two weeks (Q2W) | Experimental | 110mg for 6 doses, every 2 weeks, subcutaneous (SC) Receives: Biological: CM326 |
| CM326 110 mg, once every four weeks (Q4W) | Experimental | 110mg for 3 doses, every 4 weeks, subcutaneous (SC) Receives: Biological: CM326 |
| CM326 220 mg, once every two weeks (Q2W) | Experimental | 220mg for 6 doses, every 2 weeks, subcutaneous (SC) Receives: Biological: CM326 |
| CM326 220 mg, once every four weeks (Q4W) | Experimental | 220mg for 3 doses, every 4 weeks, subcutaneous (SC) Receives: Biological: CM326 |
| Placebo | Placebo comparator | Placebo for 6 doses, every 2 weeks, subcutaneous (SC) and placebo for 3 doses, every 4 weeks, subcutaneous (SC) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AE)
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Measured: Up to week 24
Secondary outcomes (22)
Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
Time to reach peak concentration (Tmax)
Measured: Up to Week 24
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
Peak Plasma concentration (Cmax)
Measured: Up to Week 24
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve (AUC)
Measured: Up to Week 24
Pharmacokinetics (PK) parameter : Clearance rate (CL/F)
Clearance rate (CL/F)
Measured: Up to Week 24
Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)
Elimination half life (T1/2z)
Measured: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Measured: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration
Changes from baseline in eosinophil count after CM326 administration
Measured: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Measured: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Measured: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Measured: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration
Changes from baseline in serum periostin concentration after CM326 administration
Measured: Up to Week 24
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Measured: Up to Week 24
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 Week 24
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 Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) 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 Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) 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 Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) 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 Week 24
Change from baseline in Eczema Area and Severity Index (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 Week 24
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Measured: Up to Week 24
Percent change from baseline in Numerical Rating Scale (NRS)
The range of NRS is from 0 (no itch)-10 (worst imaginable itch)
Measured: Up to Week 24
Body surface area (BSA) of involvement of atopic dermatitis
Change from baseline in percent of BSA
Measured: Up to Week 24
Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit
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
Measured: Up 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 posted11 Jan 2022
- Study start17 Feb 2022
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 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
- NCT05186922
- Sponsor's protocol ID
- CM326AD001
- Status last verified
- Feb 2022
- First submitted
- 13 Dec 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. 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 2 Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Moderate-severe Atopic Dermatitis Subjects
- ClinicalTrials.gov ID
- NCT05186922
- Acronym / sponsor ID
- CM326AD001
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Keymed Biosciences Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 11 Jan 2022 (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 CM326 in moderate-severe AD subjects.
Detailed description
The study consists of 3 periods, a up-to-4-week Screening Period, a 12-week randomized Treatment Period and a 12-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
- 6
| Arm | Type | Receives |
|---|---|---|
| CM326 55 mg, once every two weeks (Q2W) | Experimental | Biological: CM32655mg for 6 doses, every 2 weeks, subcutaneous (SC) |
| CM326 110 mg, once every two weeks (Q2W) | Experimental | Biological: CM326110mg for 6 doses, every 2 weeks, subcutaneous (SC) |
| CM326 110 mg, once every four weeks (Q4W) | Experimental | Biological: CM326110mg for 3 doses, every 4 weeks, subcutaneous (SC) |
| CM326 220 mg, once every two weeks (Q2W) | Experimental | Biological: CM326220mg for 6 doses, every 2 weeks, subcutaneous (SC) |
| CM326 220 mg, once every four weeks (Q4W) | Experimental | Biological: CM326220mg for 3 doses, every 4 weeks, subcutaneous (SC) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo for 6 doses, every 2 weeks, subcutaneous (SC) and placebo for 3 doses, every 4 weeks, subcutaneous (SC) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- With confirmed Atopic Dermatitis (AD) at least 12 months before the screening
- Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline
- Investigator's Global Assessment (IGA) score ≥3 at screening and baseline
- Body Surface Area (BSA) of involvement of atopic dermatitis ≥10% at screening and baseline
- The weekly mean score of daily peaks in pruritus NRS at baseline ≥4
Key exclusion criteria (4 listed)
- Not enough washing-out period for previous therapy.
- Presence of other concomitant and poorly controlled serious diseases or recurrent chronic diseases, including but not limited to active infections, cardiovascular and cerebrovascular diseases, pulmonary tuberculosis or other pathogen infections, diabetes mellitus, autoimmune diseases, human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or parasitosis, neoplasm malignant, etc.
- Patients with severe hepatic or renal impairment, characterized by aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times of upper limit of normal (ULN), total bilirubin >1.5 times of upper limit of normal (ULN) or serum creatinine level > upper limit of normal (ULN).
- Womens 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 | CM326 110 mg, once every four weeks (Q4W), CM326 110 mg, once every two weeks (Q2W), CM326 220 mg, once every four weeks (Q4W), CM326 220 mg, once every two weeks (Q2W), CM326 55 mg, once every two weeks (Q2W) |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Incidence of Adverse Events (AE)
Time frame: Up to week 24
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
22 secondary outcomes
Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
Time frame: Up to Week 24
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
Time frame: Up to Week 24
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve (AUC)
Time frame: Up to Week 24
Pharmacokinetics (PK) parameter : Clearance rate (CL/F)
Time frame: Up to Week 24
Pharmacokinetics (PK) parameter : Elimination half life (T1/2z)
Time frame: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after CM326 administration
Time frame: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in eosinophil count after CM326 administration
Time frame: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum total immunoglobulin E (IgE) concentration after CM326 administration
Time frame: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-5 (IL-5) concentration after CM326 administration
Time frame: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in plasma interleukin-13 (IL-13) concentration after CM326 administration
Time frame: Up to Week 24
Pharmacodynamics (PD): Changes from baseline in serum periostin concentration after CM326 administration
Time frame: Up to Week 24
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: Up to Week 24
Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit
Time frame: Up to Week 24
Proportion of patients with IGA reduction from baseline of ≥2 points at each visit
Time frame: Up to Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline) at each visit
Time frame: Up to Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at each visit
Time frame: Up to Week 24
Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline) at each visit
Time frame: Up to Week 24
Change from baseline in Eczema Area and Severity Index (EASI) score at each visit
Time frame: Up to Week 24
Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 and ≥4 points from baseline
Time frame: Up to Week 24
Percent change from baseline in Numerical Rating Scale (NRS)
Time frame: Up to Week 24
Body surface area (BSA) of involvement of atopic dermatitis
Time frame: Up to Week 24
Changes from baseline in Dermatology Life Quality Index (DLQI) at each visit
Time frame: Up to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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 1/2 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 6 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 9 Mar 2022. 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 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?
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?
Incidence of Adverse Events (AE) (time frame: Up to week 24). 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 9 Mar 2022.