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Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis (AD)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jaktinib
Jaktinib
Jaktinib
placebo
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Meet the Chinese diagnostic criteria for atopic dermatitis (Zhang's criteria) and be diagnosed as atopic dermatitis.
  • Participants must have moderate to severe AD at screening and randomization.
  • Participants must have inadequate response to topical medications within 6 months of screening.
  • Agree to use emollients daily

Exclusion Criteria:

  • Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization.
  • Have received certain types of vaccinations.
  • Participants who do not agree to use adequate contraception during the trial and within 4 weeks after the last dose.
  • Any Participants whom the investigator deems inappropriate for participation in this clinical study

Sites / Locations

  • The second xiangya hospital of central south university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Jaktinib 50mg Bid

Jaktinib 75mg Bid

Jaktinib 100mg Bid

placebo

Arm Description

Jaktinib 50mg Bid+ Placebo 50mg Bid+Placebo 75mg Bid

Jaktinib 75mg Bid+ Placebo 100mg Bid

Jaktinib 100mg Bid+ Placebo 75mg Bid

Placebo 100mg Bid+ Placebo 75mg Bid

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD)

Secondary Outcome Measures

Percentage of Participants Achieving IGA of 0 or 1.
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.

Full Information

First Posted
September 1, 2020
Last Updated
March 22, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04539639
Brief Title
Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis
Acronym
AD
Official Title
A Multi-center,Randomized,Double-blind,Placebo,Parallel-controlled Phase II Clinical Study of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
May 19, 2022 (Actual)
Study Completion Date
May 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.
Detailed Description
The study is divided into two stages, the first stage test (1-12 weeks): the main test; the second stage test (13-24 weeks): the extended test. The main test：The trial set up 4 treatment groups, including 3 dose exploration groups, Jaktinib 50mg Bid, 75mg Bid, 100mg Bid group and 1 placebo control group. The extended test：Subjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid, 75mg Bid, and 100mg Bid treatments at a ratio of 1:1:1 (randomized in a blinded state and completed by IWRS in the background), the main test group (50mg Bid, 75mg Bid, 100mg Bid group) subjects still maintain the original dose after 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jaktinib 50mg Bid
Arm Type
Experimental
Arm Description
Jaktinib 50mg Bid+ Placebo 50mg Bid+Placebo 75mg Bid
Arm Title
Jaktinib 75mg Bid
Arm Type
Experimental
Arm Description
Jaktinib 75mg Bid+ Placebo 100mg Bid
Arm Title
Jaktinib 100mg Bid
Arm Type
Experimental
Arm Description
Jaktinib 100mg Bid+ Placebo 75mg Bid
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 100mg Bid+ Placebo 75mg Bid
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
In the morning: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib; In the evening: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib.
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib; In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib.
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
In the morning: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib; In the evening: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo;In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline
Description
The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of atopic dermatitis (AD)
Time Frame
At Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving IGA of 0 or 1.
Description
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time Frame
Treatment at 2,4,8,12,16,20,24 weeks
Title
Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement
Description
The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.
Time Frame
Treatment at 2,4,8,12,16,20,24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet the Chinese diagnostic criteria for atopic dermatitis (Zhang's criteria) and be diagnosed as atopic dermatitis. Participants must have moderate to severe AD at screening and randomization. Participants must have inadequate response to topical medications within 6 months of screening. Agree to use emollients daily Exclusion Criteria: Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization. Have received certain types of vaccinations. Participants who do not agree to use adequate contraception during the trial and within 4 weeks after the last dose. Any Participants whom the investigator deems inappropriate for participation in this clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qianjin Lu
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second xiangya hospital of central south university
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis

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