A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis

NCT ID: NCT04612699

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2022-08-15

Brief Summary

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This is study designed to investigate the efficacy and safety of Jaktinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.

Detailed Description

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Conditions

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Moderate-to-Severe Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Jaktinib 50mg Bid

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

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Jaktinib 75mg Bid

Jaktinib 75mg Bid+ Placebo 50mg\*2 Bid

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Jaktinib 100mg Bid

Jaktinib 50mg\*2 Bid+ Placebo 75mg Bid

Group Type EXPERIMENTAL

Jaktinib

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Placebo

Placebo 50mg\*2 Bid+ Placebo 75mg Bid

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Jaktinib

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18\~65 years old (including lower limit), no gender limit;
* You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study;
* You must have active plaque psoriasis covering at least 10% body surface area; You must have Psoriasis Area and Severity Index (PASI) score of at least 12;You must have Static Physician's Global Assessment (sPGA) score of at least 3;
* The patient can communicate well with the investigator and follow the research and follow-up procedures;
* Understand and voluntarily sign the informed consent form.

Exclusion Criteria

* You must not have prior treatment with an oral Janus kinase (JAK) inhibitor;
* You must not have received a phototherapy within 4 weeks prior to entry into the study;
* You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
* You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xinghua Gao, PhD

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

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The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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ZGJAK010

Identifier Type: -

Identifier Source: org_study_id

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