Clinical trial NCT04566666: To Assess the Effect of SCD-044 Treatment on Moderate to Severe Plaque Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy And Safety of SCD-044 in the Treatment of Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Moderate to Severe Plaque Psoriasis
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis.

Detailed description: This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to determine the effect of SCD-044 in subjects with moderate to severe plaque psoriasis.

Eligibility criteria: Inclusion Criteria:

1. Males and non-pregnant non-lactating females with a diagnosis of predominantly plaque psoriasis for ≥ 6 months as determined by subject interview and confirmation of diagnosis through physical examination by Investigator.
2. Aged at least 18 years.
3. Subjects with no history of active TB or symptoms of TB

Exclusion Criteria:

1. Subjects with non-plaque forms of psoriasis-like erythrodermic psoriasis, pustular psoriasis, medication-induced, or medication exacerbated psoriasis or new-onset guttate psoriasis.
2. Subjects who have anticipated the requirement of topical therapy, phototherapy, or systemic therapy for psoriasis during the trial.
3. Subjects with history or presence of uveitis

Primary outcomes:
measure: Proportion of subjects with at least 75% improvement in PASI (PASI 75)
timeFrame: Week16
Secondary outcomes:
measure: Investigator's Global Assessment (IGA) score
timeFrame: Week 16
measure: Change in Psoriasis Area and Severity Index (PASI) scores
timeFrame: Week 52
measure: Psoriasis Area and Severity Index (PASI) response rate
timeFrame: Week 52
measure: Change in Psoriasis symptoms and signs diary (PSSD)
timeFrame: Week 52
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: Week 52
measure: Investigator's Global Assessment (IGA) score
timeFrame: Week 52
measure: Change in body surface area (BSA)
timeFrame: Week 52
measure: Patient Global Impression of Severity (PGIS)
timeFrame: Week 52
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 52
measure: Evaluate pharmacokinetic parameter
timeFrame: Week 52
measure: Subjects with adverse events
timeFrame: Week 56
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma Clinical Trials, LLC
state: Arizona
city: Encino
country: United States
facility: T. Joseph Raoof Md, Imc./Encino Research Center
state: California
city: Los Angeles
country: United States
facility: Metropolis Dermatology
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: Castle Rock
country: United States
facility: Clarity Dermatology
state: Colorado
city: DeLand
country: United States
facility: Accel Research Sites Network - Annexus Dermatology & Aestheitcs
state: Florida
city: Delray Beach
country: United States
facility: Palm Beach Dermatology Group
state: Florida
city: Doral
country: United States
facility: Revival Research Corporation
state: Florida
city: Fort Lauderdale
country: United States
facility: FXM Clinical Research Fort Lauderdale
state: Florida
city: Hialeah Gardens
country: United States
facility: Evolution Clinical Trials, Inc
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Miami
country: United States
facility: MedOne Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Century Research LLC
state: Florida
city: Miami
country: United States
facility: FXM Clinical Research Miami
state: Florida
city: Miami
country: United States
facility: JD Medical Group, LLC
state: Florida
city: Miramar
country: United States
facility: FXM Clinical Research Miramar
state: Florida
city: Tampa
country: United States
facility: Adtremed Inc
state: Florida
city: Tampa
country: United States
facility: Advanced Clinical Research Institute
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: College Park
country: United States
facility: Oracle Clinical Research
state: Georgia
city: West Lafayette
country: United States
facility: Physicians Research Group
state: Indiana
city: Troy
country: United States
facility: Revival research Institute, LLC
state: Michigan
city: Dallas
country: United States
facility: DFW Clinical Research, LLC
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Stride Clinical Research
state: Texas
city: Springville
country: United States
facility: Springville Dermatology/ CCT Research
state: Utah
city: Arlington
country: United States
facility: Skin DC Derm
state: Virginia
city: La libertad
country: El Salvador
facility: Clinica de Dermatologia y Cirugia de Piel
city: San Salvador
country: El Salvador
facility: Clinica Dermatologica
city: San Salvador
country: El Salvador
facility: Clinica Vargas
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation Ltd.
city: Tartu
country: Estonia
facility: Clinical Research Centre OU
city: Tbilisi
country: Georgia
facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
city: Tbilisi
country: Georgia
facility: Israeli - Georgian Medical Research Clinic Helsikor LLC
city: Tbilisi
country: Georgia
facility: Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
city: Tbilisi
country: Georgia
facility: Emergency Cardiology Center by Academician G. Chapidze LLC
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: TIM - Tbilisi Institute of Medicine LLC
city: Tbilisi
country: Georgia
facility: David Abuladze Georgian-Italian Clinic LLC
city: Bialystok
country: Poland
facility: ClinicMed
city: Gdansk
country: Poland
facility: Synexus Polska Sp. z o.o. Branch in Gdansk
city: Klodzko
country: Poland
facility: GLOBE Clinical Research
city: Krakow
country: Poland
facility: Dobry Lekarz' Modern Therapies Center Limited Liability Company
city: Krakow
country: Poland
facility: Landa Specialist Doctor's Offices
city: Lodz
country: Poland
facility: Appletreeclinics Clinical Research Centre
city: Poznan
country: Poland
facility: EMC Medical Institute Joint Stock Company, "Certus" Private Healthcare Facility Hospital No. 1
city: Szczecin
country: Poland
facility: TWOJA PRZYCHODNIA Medical Centre of Szczecin, Twoja Przychodnia SCM
city: Warsaw
country: Poland
facility: National Medical Institute of the MSWiA, Clinical Department of Dermatology
Study officials:
References: