- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04612699
A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis (PSO)
March 4, 2024 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Jaktinib in Patients With Moderate-to-Severe Plaque Psoriasis
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
123
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xinghua Gao, PhD
- Phone Number: +86-024-83282524
- Email: gaobarry@hotmail.com
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110000
- The First Affiliated Hospital of China Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Jaktinib 50mg Bid
Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid
|
Administered orally
Administered orally
|
Experimental: Jaktinib 75mg Bid
Jaktinib 75mg Bid+ Placebo 50mg*2 Bid
|
Administered orally
Administered orally
|
Experimental: Jaktinib 100mg Bid
Jaktinib 50mg*2 Bid+ Placebo 75mg Bid
|
Administered orally
Administered orally
|
Placebo Comparator: Placebo
Placebo 50mg*2 Bid+ Placebo 75mg Bid
|
Administered orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
Time Frame: Week 12
|
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Jaktinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
Time Frame: Week 8、12、16、20、24
|
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling.
For the analysis of responses, the participant's psoriasis is assessed as clear
|
Week 8、12、16、20、24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xinghua Gao, PhD, First Hospital of China Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2021
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 29, 2020
First Submitted That Met QC Criteria
November 2, 2020
First Posted (Actual)
November 3, 2020
Study Record Updates
Last Update Posted (Actual)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZGJAK010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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