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Completed

NCT Number: NCT05003531

A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PeKing University People's Hostpital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
  • Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)

Exclusion criteria

  • History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
  • Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
  • Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23within 6 months of the first administration of study agent
  • Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
  • Has received any conventional therapeutic agent within 1 months of the first administration of study agent
  • Has received any topic therapeutic agent within 2 weeks of the first administration of study agent

Treatment and study plan

IBI112 dose 2

Drug

Participants will receive placebo or dose 2 IBI112 SC

IBI112 dose 4

Drug

Participants will receive placebo or dose 4 IBI112 SC

IBI112 dose 1

Drug

Participants will receive placebo or dose 1 IBI112 SC

IBI112 dose 3

Drug

Participants will receive placebo or dose 3 IBI112 SC

Placebo

Drug

Participants will receive placebo SC

Primary outcomes

  1. Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16

    Time frame: Week 16

    PASI 90 is defined as at least a 90% reduction in PASI relative to baseline

Secondary outcomes

  1. Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16

    Time frame: Week 16

    PASI 75 is defined as at least a 75% reduction in PASI relative to baseline

  2. Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16

    Time frame: Week 16

    PASI 100 is defined as at least a 100% reduction in PASI relative to baseline

  3. Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16

    Time frame: Week 16

    PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe

  4. Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 16

    Time frame: Week 16

    PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe

  5. Change from Baseline in Dermatology life quality index(DLQI) at week 16

    Time frame: Week 16

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life

  6. Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52

    Time frame: Week 52

    PASI 90 is defined as at least a 90% reduction in PASI relative to baseline

  7. Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52

    Time frame: Week 52

    PASI 100 is defined as at least a 100% reduction in PASI relative to baseline

  8. Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52

    Time frame: Week 52

    PASI 75 is defined as at least a 75% reduction in PASI relative to baseline

  9. Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 52

    Time frame: Week 52

    PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe

  10. Percentage of patients with Physician Global Assessment(PGA) Score of Cleared(0) at week 52

    Time frame: Week 52

    PGA of psoriasis is used to determine the participant's psoriasis lesions overall at a given time point.PGA score ranges from 0-4,0=cleared, 1= minimal ,2=mild, 3= moderate, 4= marked, 5= severe

  11. Change from Baseline in Dermatology life quality index(DLQI) at week 52

    Time frame: Week 52

    The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase II Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of IBI112 in Different Dose Regimens for the Treatment of Subjects With Moderate-to-severe Plaque Psoriasis

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 12, 2021
Registry last updated
Jan 25, 2024

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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