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

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ClinicalTrials.gov Identifier: NCT04539639
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Jacketinib Drug: placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Jaktinib 50mg Bid
Jaktinib 50mg Bid+ Placebo 50mg Bid+Placebo 75mg Bid
 Drug: Jacketinib
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.
Experimental: Jaktinib 75mg Bid
Jaktinib 75mg Bid+ Placebo 100mg Bid
 Drug: Jacketinib
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.
Experimental: Jaktinib 100mg Bid
Jaktinib 100mg Bid+ Placebo 75mg Bid
 Drug: Jacketinib
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.
Placebo Comparator: placebo
Placebo 100mg Bid+ Placebo 75mg Bid
 Drug: placebo
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving at least a 50% Reduction in Eczema Area and Severity Index (EASI 50) from Baseline [ Time Frame: At Week 12 ]
    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 :
  1. Percentage of Participants Achieving IGA of 0 or 1. [ Time Frame: Treatment at 2,4,8,12,16,20,24 weeks ]
    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.

  2. Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement [ Time Frame: Treatment at 2,4,8,12,16,20,24 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539639


Contacts
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Contact: Qianjin Lu, PhD +8673185295999 Qianlu5860@gmail.com
Contact: Jianzhong Zhang, phD

Locations
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China, Hunan
139 People's Middle Road Recruiting
Changsha, Hunan, China, 410008
Contact: Qianjin M Road    +8673185295999    Qianlu5860@gmail.com   
Principal Investigator: Qianjin Lu, phD         
Principal Investigator: Jianzhong Zhang, phD         
Sponsors and Collaborators
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Investigators
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Study Chair: Qianjin Lu Central South University
More Information
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Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT04539639    
Other Study ID Numbers: ZGJAK011
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases