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Completed

NCT Number: NCT05645627

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

The purpose of this study is to evaluate the efficacy and safety of IBI112 in the treatment of participants with moderate to severe plaque-type 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 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

  • 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-17within 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

Drug

IBI112 by subcutaneous injection through week 16 ,and then will receive Dose 3 IBI112 by subcutaneous injection through week 48

placebo /IBI112

Drug

placebo by subcutaneous injection cross over IBI112 by subcutaneous injection at week 16 through week 48

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

  2. Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16

    Time frame: Week 16

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

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 achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16

    Time frame: Week 16

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

  4. 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

  5. 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

  6. Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 52

    Time frame: Week 52

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

  7. 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

  8. 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

  9. Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 52

    Time frame: Week 52

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

  10. 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 Ⅲ, Multicenter, Randomized, Double-blind, 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
2023
Primary completion
2023
Study completion
2024
First posted
Dec 9, 2022
Registry last updated
Oct 29, 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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