Clinical trial NCT05645627: A Study to Evaluate IBI112 in the Treatment of Psoriasis With Moderate to Severe Plaque Psoriasis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 16
timeFrame: Week 16
measure: Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 16
timeFrame: Week 16
measure: Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 16
timeFrame: Week 16
measure: Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 16
timeFrame: Week 16
measure: Change from Baseline in Dermatology life quality index(DLQI) at week 16
timeFrame: Week 16
measure: Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 at week 52
timeFrame: Week 52
measure: Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) at Week 52
timeFrame: Week 52
measure: Percentage of patients achieving Psoriasis Area and severity index(PASI) 75 at week 52
timeFrame: Week 52
measure: Percentage of patients achieving Psoriasis Area and severity index(PASI) 100 at week 52
timeFrame: Week 52
measure: Percentage of patients achieving an static Physician's Global Assessment (sPGA) Score of Cleared (0) at Week 52
timeFrame: Week 52
measure: Change from Baseline in Dermatology life quality index(DLQI) at week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
Study officials:
References: