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NCT Number: NCT05970978

A Study of IBI112 in Chinese Patients With Psoriasis Who Were Previously Treated With Biologics

This is a multicenter, open-label study aim to evaluate the efficacy and safety of IBI112 in Chinese participants with plaque psoriasis who were treated with biologics and switched to IBI112. The study will enroll 160 participants who were diagnosed with plaque psoriasis. The whole study consists of 4 weeks of screening, 32 or 36 weeks of treatment and a safety follow-up visit at Week 44.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Hospital of Shandong First Medical University (Shandong Provincial Hospitial of Dermatology)

Jinan, Shandong, 250000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 to 75 years old;
  • Evaluated suitable for continuing biologic therapy for plaque psoriasis by the investigator;
  • Received previous biologic therapy with at least 4 months.

Exclusion criteria

  • Diagnosed with guttate psoriasis, pustular psoriasis, erythrodermic psoriasis, or drug-induced psoriasis (e.g., psoriasis caused by beta blockers, calcium channel inhibitors, etc.) at screening;
  • Previously treated with IBI112 or other IL-23 inhibitors;
  • Treated with two biologics for psoriasis within 4 months prior to screening;
  • Treated with topical therapy for psoriasis within 2 weeks prior to the first dose administration, or treated with systemic non-biological agents or phototherapy within 4 weeks prior to the first dose administration;
  • Treated with Natalizumab, or B/T cell regulators (e.g., Rituximab, Abatacept, or Visilizumab) within 12 months prior to the first dose administration;
  • Not willing to avoid constant sunshine and other ultraviolet light sources exposure during the study;
  • Treated with an investigational biologic within 6 months prior to the first dose administration, or any investigational therapy within 30 days, or an investigational drug within 5 half-lives, or currently participating in a clinical study.

Treatment and study plan

regular treatment

Drug

IBI112 200mg s.c. at week 0, 12, 24 and 36.

Other names: Response to previous biologic therapy

Intensive treatment

Drug

IBI112 200mg s.c. at week 0, 4, 8, 20 and 32.

Other names: Poor response to previous biologic therapy

Primary outcomes

  1. Percentage of participants who achieve sPGA clean (0) or nearly clean (1) ,and BSA < 3%

    Time frame: Week 16

Secondary outcomes

  1. Percentage of participants who achieve sPGA clean (0) at Week 16.

    Time frame: Week 16

  2. Percentage of participants with a DLQI score of 0/1 at Week 16.

    Time frame: Week 16

  3. Percentage of participants with sPGA 0/1 or sPGA 0 or DLQI 0/1 at Week 44.

    Time frame: Week 44

  4. Percentage of participants who achieve sPGA 0 or 1 at week 16 and maintain that up to Week 44

    Time frame: Week 16 up to Week 44

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IBI112 in Participants With Psoriasis Who Were Treated With Biologics and Switched to IBI112

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 2, 2023
Registry last updated
Apr 27, 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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