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

Primary Purpose

Moderate-to-Severe Plaque Psoriasis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Jaktinib
Placebo
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate-to-Severe Plaque Psoriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Jaktinib 50mg Bid

Jaktinib 75mg Bid

Jaktinib 100mg Bid

Placebo

Arm Description

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

Jaktinib 75mg Bid+ Placebo 50mg*2 Bid

Jaktinib 50mg*2 Bid+ Placebo 75mg Bid

Placebo 50mg*2 Bid+ Placebo 75mg Bid

Outcomes

Primary Outcome Measures

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])
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.

Secondary Outcome Measures

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])
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

Full Information

First Posted
October 29, 2020
Last Updated
November 28, 2022
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04612699
Brief Title
A Phase 2 Study of Jaktinib in Participants With Moderate to Severe Psoriasis
Acronym
PSO
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Jaktinib in Patients With Moderate-to-Severe Plaque Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-Severe Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jaktinib 50mg Bid
Arm Type
Experimental
Arm Description
Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid
Arm Title
Jaktinib 75mg Bid
Arm Type
Experimental
Arm Description
Jaktinib 75mg Bid+ Placebo 50mg*2 Bid
Arm Title
Jaktinib 100mg Bid
Arm Type
Experimental
Arm Description
Jaktinib 50mg*2 Bid+ Placebo 75mg Bid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 50mg*2 Bid+ Placebo 75mg Bid
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
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])
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
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])
Description
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
Time Frame
Week 8、12、16、20、24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinghua Gao, PhD
Phone
+86-024-83282524
Email
gaobarry@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinghua Gao, PhD
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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