Back to resultsA Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jaktinib Hydrochloride Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: The investigator thinks that the subject can continue to benefit from participating in the extension trial; Fully understand the extension trial and sign the informed consent form; Complete the ZGJAK025 trial for 16 weeks and have good compliance; It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks; Exclusion Criteria: Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal; The investigator thinks that the subject is not suitable for the trial.
Sites / Locations
- 11 Xizhimen South StreetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Jaktinib 100mg BID
Jaktinib 75mg BID
Placebo
Arm Description
Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day
Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day
Drug: Placebo Orally administered, twice a day
Outcomes
Primary Outcome Measures
Number and percentage of subjects with treatment emergent adverse event (TEAE)
Safety of the drug
Number and percentage of subjects with Serious Adverse Event (SAE)
Safety of the drug
Secondary Outcome Measures
The diachronic change in the proportion of subjects whose total Eczema area and severity index （EASI） score decreased by ≥ 75% from baseline
The proportion of subjects who reached EASI-75
The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment （IGA） score reached 0 or 1 and decreased by ≥ 2 points from baseline
The proportion of subjects who reached IGA 0/1
The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale （NRS） score improved by ≥ 4 points from baseline
The proportion of subjects who reached NRS4
Full Information
NCT ID
NCT05676242
First Posted
December 30, 2022
Last Updated
September 12, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05676242
Brief Title
A Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
Official Title
A Phase III Extended Clinical Trial of Long-term Safety and Efficacy of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
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
To observe the safety and effectiveness of long-term use of jaktinib hydrochloride tablets in the treatment of moderate and severe atopic dermatitis
Detailed Description
If the enrolled subjects received the treatment of jaktinib hydrochloride tablets in the ZGJAK025 trial, they will continue to use the drug at the original dosage; If the enrolled subjects received placebo treatment in the ZGJAK025 trial, they will receive 100mg BID of jaktinib hydrochloride tablets, 75mg BID of jaktinib hydrochloride tablets or placebo at a ratio of 1:1:1 at random, and continue to take the drug on an empty stomach, with the longest continuous treatment not exceeding 36 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jaktinib 100mg BID
Arm Type
Experimental
Arm Description
Drug: Jaktinib Hydrochloride Tablet 100mg dosage, orally administered, twice a day
Arm Title
Jaktinib 75mg BID
Arm Type
Experimental
Arm Description
Drug: Jaktinib Hydrochloride Tablet 75mg dosage, orally administered, twice a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: Placebo Orally administered, twice a day
Intervention Type
Drug
Intervention Name(s)
Jaktinib Hydrochloride Tablet
Intervention Description
Orally administered, twice a day
Primary Outcome Measure Information:
Title
Number and percentage of subjects with treatment emergent adverse event (TEAE)
Description
Safety of the drug
Time Frame
36 weeks after the first dose
Title
Number and percentage of subjects with Serious Adverse Event (SAE)
Description
Safety of the drug
Time Frame
36 weeks after the first dose
Secondary Outcome Measure Information:
Title
The diachronic change in the proportion of subjects whose total Eczema area and severity index （EASI） score decreased by ≥ 75% from baseline
Description
The proportion of subjects who reached EASI-75
Time Frame
36 weeks after the first dose
Title
The diachronic change of the proportion of subjects whose systemic Investigator's Global Assessment （IGA） score reached 0 or 1 and decreased by ≥ 2 points from baseline
Description
The proportion of subjects who reached IGA 0/1
Time Frame
36 weeks after the first dose
Title
The diachronic change in the proportion of subjects whose pruritus Numerical Rating Scale （NRS） score improved by ≥ 4 points from baseline
Description
The proportion of subjects who reached NRS4
Time Frame
36 weeks after the first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The investigator thinks that the subject can continue to benefit from participating in the extension trial;
Fully understand the extension trial and sign the informed consent form;
Complete the ZGJAK025 trial for 16 weeks and have good compliance;
It is expected that the time interval between the first administration and the last administration of ZGJAK025 trial for the subject should be ≤ 4 weeks;
Exclusion Criteria:
Within 4 weeks before enrollment, there were any adverse events ≥ 3 levels related to the test drug that did not return to level 1 or normal;
The investigator thinks that the subject is not suitable for the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cong Zhang
Phone
+86-0512-57018308
Email
zhangc@zelgen.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Wu
Facility Information:
Facility Name
11 Xizhimen South Street
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianzhong Zhang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase III Extended Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Moderate and Severe Atopic Dermatitis
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