Clinical trial NCT04684485: To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis
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 Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 250
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 Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.

Detailed description: This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

1. Aged at least 18 years.
2. Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka.
3. Moderate to severe atopic dermatitis at Screening and Baseline

Exclusion Criteria:

1. Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study.
2. Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy.
3. History or presence of uveitis

   -

Primary outcomes:
measure: Eczema Area and Severity Index (EASI) score
timeFrame: Week16
Secondary outcomes:
measure: Validated Investigator's Global Assessment (vlGA) scale
timeFrame: Week 16
measure: Eczema Area and Severity Index (EASI) score
timeFrame: Week 32
measure: Validated Investigator's Global Assessment (vlGA) scale.
timeFrame: Week 32
measure: Peak Pruritus Numeric Rating Scale (PP-NRS)
timeFrame: Week 32
measure: SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 response
timeFrame: Week 32
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Week 32
measure: Percent body surface area (BSA)
timeFrame: Week 32
measure: Patient Oriented Eczema Measure (POEM) score
timeFrame: Week 32
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 32
measure: Patient Global Impression of Severity (PGIS)
timeFrame: Week 32
measure: Adverse events.
timeFrame: Week 36
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Omni Dermatology
state: Arizona
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: Providence Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Unison Clinical Trials
state: California
city: West Covina
country: United States
facility: Providere' Research Inc.
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: Doral
country: United States
facility: Revival Research Corporation
state: Florida
city: Florida City
country: United States
facility: Advanced Clinical Research Institute
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: Hialeah
country: United States
facility: Evolution Research Center
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research
state: Florida
city: Miami
country: United States
facility: Advanced Clinical Research Network, Corp
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: 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
state: Texas
city: El Paso
country: United States
facility: 3A Research
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: San Salvador
country: El Salvador
facility: Clinica Vargas
city: San Salvador
country: El Salvador
facility: Clinica Dermatologica
city: Santa Tecla
country: El Salvador
facility: Clinica de Dermatologia y Cirugia de Piel
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 Healthycore 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: KLIMED
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: Lublin
country: Poland
facility: Dermedic Iwona Zdybska
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
city: Warsaw
country: Poland
facility: Synexus Polska Sp. z o.o. Branch in Warsaw
city: Warsaw
country: Poland
facility: Military Institute of Medicine - National Research Institute, Department of Dermatology CWBK
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Branch in Wroclaw
Study officials:
References: