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

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04612699

Collaborator

(none)

120

Enrollment

Location

Arms

32.7

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Moderate-to-Severe Plaque Psoriasis	Drug: Jaktinib Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of Jaktinib in Patients With Moderate-to-Severe Plaque Psoriasis

Actual Study Start Date :

Mar 11, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Jaktinib 50mg Bid Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid	Drug: Jaktinib Administered orally Drug: Placebo Administered orally
Experimental: Jaktinib 75mg Bid Jaktinib 75mg Bid+ Placebo 50mg*2 Bid	Drug: Jaktinib Administered orally Drug: Placebo Administered orally
Experimental: Jaktinib 100mg Bid Jaktinib 50mg*2 Bid+ Placebo 75mg Bid	Drug: Jaktinib Administered orally Drug: Placebo Administered orally
Placebo Comparator: Placebo Placebo 50mg*2 Bid+ Placebo 75mg Bid	Drug: Placebo Administered orally

Outcome Measures

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]) [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.

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]) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China	110000

Sponsors and Collaborators

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

Principal Investigator: Xinghua Gao, PhD, First Hospital of China Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

ClinicalTrials.gov Identifier:

NCT04612699

Other Study ID Numbers:

ZGJAK010

First Posted:

Nov 3, 2020

Last Update Posted:

Mar 29, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Psoriasis

Study Results

No Results Posted as of Mar 29, 2021