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

Atopic Dermatitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539639
• Other study ID #: ZGJAK011
• Status: Completed
• Phase: Phase 2
• Start date: December 2, 2020
• Est. completion date: May 19, 2022

Study information

• Verified date: March 2023
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Jaktinib
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.
• Jaktinib
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.
• Jaktinib
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
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.

Locations

Country	Name	City	State
China	The second xiangya hospital of central south university	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	At Week 12
Secondary	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.	Treatment at 2,4,8,12,16,20,24 weeks
Secondary	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.	Treatment at 2,4,8,12,16,20,24 weeks