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

NCT04539639 | Completed Phase 2

• 1 other identifier: ZGJAK011
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants Achieving IGA of 0 or 1.

  Treatment at 2,4,8,12,16,20,24 weeks

• Percentage of Participants Achieving Investigator's Global Assessment (IGA) of 0 or 1 with a ≥2 Point Improvement

  Treatment at 2,4,8,12,16,20,24 weeks

Study Arms (4)

Jaktinib 50mg Bid

EXPERIMENTAL

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

Drug: Jaktinib

Jaktinib 75mg Bid

EXPERIMENTAL

Jaktinib 75mg Bid+ Placebo 100mg Bid

Drug: Jaktinib

Jaktinib 100mg Bid

EXPERIMENTAL

Jaktinib 100mg Bid+ Placebo 75mg Bid

Drug: Jaktinib

placebo

PLACEBO COMPARATOR

Placebo 100mg Bid+ Placebo 75mg Bid

Drug: placebo

Interventions

Jaktinib DRUG

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 50mg Bid

placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The second xiangya hospital of central south university

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Qianjin Lu

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 7, 2020
• Study Start: December 2, 2020
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)