Clinical trial NCT05399368: An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis
Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
Lead sponsor: RAPT Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 229
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: Phase 2 study of RPT193 in adults with atopic dermatitis

Detailed description: Randomized, placebo-controlled Phase 2 study of RPT193 in adults with moderate-to-severe atopic dermatitis

Eligibility criteria: Inclusion Criteria:

* Clinically confirmed diagnosis of active atopic dermatitis (AD), according to the revised Hanifin and Rajka criteria
* 12-month history of AD and had no significant flares in AD for at least 4 weeks before screening
* inadequate response to a ≥1 month treatment with topical medications
* Atopic dermatitis covering ≥10% of the body surface area
* EASI score ≥16
* Validated Investigator Global Assessment (VIGA) ≥3
* Use of emollient(s) at least 2x daily for 1 week prior to baseline
* Negative coronavirus disease (COVID)-19 results at screening

Exclusion Criteria:

* Uncontrolled moderate-to-severe asthma
* Uncontrolled diabetes
* Stage III or IV cardiac failure
* Severe renal condition
* Major surgery within 8 weeks of screening
* Immunodeficiency and/or receipt of immunosuppressive drugs within 4 weeks of baseline
* Use of systemic Janus kinase (JAK) inhibitor within 8 weeks of baseline
* Received live or live-attenuated vaccine within 4 weeks of baseline
* Prior receipt of RPT193

Primary outcomes:
measure: Clinical efficacy
timeFrame: 16 weeks
measure: Safety as measured by adverse events
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology and Skin Health Center
state: Alabama
city: Scottsdale
country: United States
facility: Perseverance Research Center
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Research Trials, LLC
state: Arkansas
city: Encinitas
country: United States
facility: California Dermatology & Clinical Research Institute
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Los Angeles
country: United States
facility: Grimes Center
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Research Institute
state: California
city: Washington
country: United States
facility: Foxhall Research Center
state: District of Columbia
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: Coral Gables
country: United States
facility: Florida Academic Centers Research and Education, LLC
state: Florida
city: Delray Beach
country: United States
facility: Palm Beach Dermatology Group
state: Florida
city: Margate
country: United States
facility: GSI Clinical Research
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research & Medical Group, LLC
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research
state: Florida
city: Macon
country: United States
facility: Skin Care Physicians of Georgia
state: Georgia
city: Marietta
country: United States
facility: Marietta Dermatology Clinical Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: Georgia Skin & Cancer Clinic
state: Georgia
city: Darien
country: United States
facility: University Dermatology and Vein Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center PC
state: Indiana
city: Louisville
country: United States
facility: Skin Sciences PLLC
state: Kentucky
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: Columbia
country: United States
facility: Schweiger Dermatology Group, PC Research Division
state: Maryland
city: Brighton
country: United States
facility: MetroBoston Clinical Partners
state: Massachusetts
city: Quincy
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Fivenson Dermatology
state: Michigan
city: Saint Joseph
country: United States
facility: St. Joseph Dermatology and Vein Clinic
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Saint Joseph
country: United States
facility: Medisearch Clinical Trials
state: Missouri
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands
state: Nebraska
city: Omaha
country: United States
facility: Skin Specialists PC (Schlessinger MD)
state: Nebraska
city: Verona
country: United States
facility: Schweiger Dermatology Group
state: New Jersey
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: JUVA Skin & Laser Center
state: New York
city: New York
country: United States
facility: Ichan School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Markowitz Medical, PLLC
state: New York
city: Boardman
country: United States
facility: Optima Research - Boardman
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Arlington
country: United States
facility: Arlington Research Center Inc.
state: Texas
city: Austin
country: United States
facility: DermResearch
state: Texas
city: Cypress
country: United States
facility: Studies in Dermatology, LLC
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Acclaim Dermatology
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology
state: Texas
city: South Jordan
country: United States
facility: Jordan Valley Dermatology Center
state: Utah
city: Richmond
country: United States
facility: West End Dermatology Associates
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Center
state: Ontario
city: Hamilton
country: Canada
facility: LEADER Research
state: Ontario
city: Ottawa
country: Canada
facility: Red Maple Trials Inc.
state: Ontario
Study officials:
References: