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

Phase 2

Completed

• Conditions: Moderate-to-Severe Plaque Psoriasis
• Interventions: Drug: Jaktinib; Drug: Placebo

• Registration Number: NCT04612699
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-02
• Study First Posted: 2020-11-03
• Study Start: 2021-03-11
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Jaktinib 50mg Bid	Placebo	Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid
Jaktinib 75mg Bid	Jaktinib	Jaktinib 75mg Bid+ Placebo 50mg\*2 Bid
Jaktinib 75mg Bid	Placebo	Jaktinib 75mg Bid+ Placebo 50mg\*2 Bid
Jaktinib 100mg Bid	Jaktinib	Jaktinib 50mg\*2 Bid+ Placebo 75mg Bid
Jaktinib 100mg Bid	Placebo	Jaktinib 50mg\*2 Bid+ Placebo 75mg Bid
Placebo	Placebo	Placebo 50mg\*2 Bid+ Placebo 75mg Bid
Jaktinib 50mg Bid	Jaktinib	Jaktinib 50mg Bid+ Placebo 50mg Bid+ Placebo 75mg Bid

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China