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Completed

NCT Number: NCT06049810

IBI112 in Moderate to Severe Plaque Psoriasis With Randomized Withdrawal and Re-treatment

The purpose of this study is to evaluate the efficacy, safety, and tolerability of IBI112 in the treatment of participants with moderate to severe psoriasis

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200443, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a diagnosis of plaque-type psoriasis for at least 6 months;
  • Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND static Physician's Global Assessment (sPGA) score of 3 (moderate) or greater; Psoriasis covering at least 10% of body surface area;
  • Must be a candidate for either systemic therapy or phototherapy for psoriasis.

Exclusion criteria

  • Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
  • Participants who have ever received IBI112 or IL-23 inhibitor
  • History or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the participant
  • Is pregnant, nursing, or planning a pregnancy (both men and women) within 6 months following the last administration of the study drug

Treatment and study plan

IBI112

Drug

Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & Dose 1 IBI112 through week 44

IBI112/placebo

Drug

Participants receive Dose 1 IBI112 through week 8 & Dose 2 IBI112 on week 20 & placebo through week 44 by subcutaneous injection

Primary outcomes

  1. Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response

    Time frame: Week 56

Secondary outcomes

  1. Percentage of participants with a PASI75 Response

    Time frame: Week 56

  2. Percentage of participants with a PASI100 Response

    Time frame: Week 56

  3. Percentage of participants with a static Investigator's Global Assessment (sIGA) score of 0 or 1

    Time frame: Week 56

  4. Percentage of participants with Dermatology Life Quality Index (DLQI) Score

    Time frame: Week 56

  5. Percentage of participants with a sIGA score of 0

    Time frame: Week 56

  6. Cumulative Maintenance Rate of PASI 90 Response Through Week 56 to Evaluate Loss of a PASI 90 Response

    Time frame: Week 56

  7. Changes of PASI Scores participants who relapse and retreatment

    Time frame: Week 56

  8. Changes of sIGA score in participants who relapse and retreatment

    Time frame: Week 56

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Randomized Withdrawal and Retreatment Phase III Clinical Trial Evaluating the Efficacy and Safety of Subcutaneous Injection of IBI112 in the Treatment of Moderate to Severe Plaque Psoriasis.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Aug 17, 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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