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

NCT04612699 | Completed Phase 2

• 1 other identifier: ZGJAK010
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate-to-Severe Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

Jaktinib 50mg Bid

EXPERIMENTAL

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

Drug: Jaktinib; Drug: Placebo

Jaktinib 75mg Bid

EXPERIMENTAL

Jaktinib 75mg Bid+ Placebo 50mg\*2 Bid

Drug: Jaktinib; Drug: Placebo

Jaktinib 100mg Bid

EXPERIMENTAL

Jaktinib 50mg\*2 Bid+ Placebo 75mg Bid

Drug: Jaktinib; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo 50mg\*2 Bid+ Placebo 75mg Bid

Drug: Placebo

Interventions

Jaktinib DRUG

Administered orally

Jaktinib 100mg Bid; Jaktinib 50mg Bid; Jaktinib 75mg Bid

Placebo DRUG

Administered orally

Jaktinib 100mg Bid; Jaktinib 50mg Bid; Jaktinib 75mg Bid; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Study Officials

• Xinghua Gao, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 3, 2020
• Study Start: March 11, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)