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

Moderate-to-Severe Plaque Psoriasis Clinical Trial

— PSO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04612699
• Other study ID #: ZGJAK010
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 11, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 123
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Moderate-to-Severe Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Jaktinib
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
China	The First Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 12
Secondary	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	Week 8?12?16?20?24