Clinical trial NCT05003531: A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 250
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 administered in different dose regimens for the treatment of patients with plaque psoriasis


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients achieving Psoriasis Area and severity index(PASI) 90 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 with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 16
timeFrame: Week 16
measure: Percentage of patients with Physician Global Assessment(PGA) 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 Psoriasis Area and severity index(PASI) 100 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 with Physician Global Assessment(PGA) Score of Cleared(0) or Minimal(1) at week 52
timeFrame: Week 52
measure: Percentage of patients with Physician Global Assessment(PGA) 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: Beijing
country: China
facility: PeKing University People's Hostpital
state: Beijing
Study officials:
References: