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Completed

NCT Number: NCT04612699

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

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.

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Key information

Conditions

Moderate-to-severe Plaque Psoriasis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Jaktinib

Drug

Administered orally

Placebo

Drug

Administered orally

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])

    Time frame: 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 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])

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

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

Acronym: PSO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 3, 2020
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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