NCT04893941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

April 25, 2021

Last Update Submit

June 3, 2021

Conditions

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to Week 12

Secondary Outcomes (14)

  • Pharmacokinetics parameter: Peak concentration (Cmax)

    Baseline to Week 12

  • Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)

    Baseline to Week 12

  • Pharmacokinetics parameter: Area under the plasma concentration-time curve from 0 to t (AUC0-t)

    Baseline to Week 12

  • Pharmacokinetics parameter: Clearance rate (CL/F)

    Baseline to Week 12

  • Pharmacodynamics parameters: Serum Thymus and activation regulated chemokine (TARC)

    Baseline to Week 12

  • +9 more secondary outcomes

Study Arms (5)

CM310 75mg arm

EXPERIMENTAL

75mg for 3 doses, every 2 weeks, SC

Drug: CM310

CM310 150mg arm

EXPERIMENTAL

150mg for 3 doses, every 2 weeks, SC

Drug: CM310

CM310 300mg arm

EXPERIMENTAL

300mg for 3 doses, every 2 weeks, SC

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

Drug: CM310

placebo arm

PLACEBO COMPARATOR

placebo for 3 doses, every 2 weeks, SC

Drug: Placebo

Interventions

CM310DRUG

IL-4Rα monoclonal antibody

CM310 150mg armCM310 300mg armCM310 600(1st)+300mg(2nd,3rd) armCM310 75mg arm
PlaceboDRUG

Placebo

placebo arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Wuxi Second Hospital

Wuxi, Jiangsu, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

Peking University People's Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Shanghai Skin Disease Hospital

Shanghai, China

Location

Related Publications (1)

  • 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.

    PMID: 38833140DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2021

First Posted

May 20, 2021

Study Start

July 21, 2020

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)