Clinical trial NCT04893941: Dose Escalation Trial of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Moderate-to-severe Atopic Dermatitis
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Not enough washing-out period for previous therapy.
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* Pregnancy.
* Other.

Primary outcomes:
measure: Safety parameters (e.g., Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing)
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Pharmacokinetics parameter: Peak concentration (Cmax)
timeFrame: Baseline to Week 12
measure: Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
timeFrame: Baseline to Week 12
measure: Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)
timeFrame: Baseline to Week 12
measure: Pharmacokinetics parameter: Clearance rate (CL/F)
timeFrame: Baseline to Week 12
measure: Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)
timeFrame: Baseline to Week 12
measure: Pharmacodynamics parameters: Blood eosinophil count (EOS)
timeFrame: Baseline to Week 12
measure: Pharmacodynamics parameters: Total IgE level
timeFrame: Baseline to Week 12
measure: Immunogenicity: Proportion of subjects with anti-drug antibody (ADA)
timeFrame: Baseline to Week 12
measure: Preliminary efficacy: Proportion of subjects with IGA 0 or 1
timeFrame: Baseline to Week 12
measure: Preliminary efficacy: Proportion of subjects with a reduction of IGA from baseline of ≥ 2 points
timeFrame: Baseline to Week 12
measure: Preliminary efficacy: Proportion of subjects with IGA 0 or 1 and a reduction of IGA from baseline of ≥ 2 points
timeFrame: Baseline to Week 12
measure: Preliminary efficacy: Proportion of subjects with EASI-50
timeFrame: Baseline to Week 12
measure: Preliminary efficacy: Proportion of subjects with EASI-75
timeFrame: Baseline to Week 12
measure: Preliminary efficacy: Proportion of subjects with improvement (reduction) of pruritus NRS from baseline
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Changsha
country: China
facility: Second Xiangya Hospital of Central South University
state: Hunan
city: Wuxi
country: China
facility: Wuxi Second Hospital
state: Jiangsu
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
Study officials:
References: