A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
NCT ID: NCT04271514
Last Updated: 2021-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
103 participants
INTERVENTIONAL
2019-08-12
2021-04-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis
NCT05399368
Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
NCT03394677
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
NCT04875169
Efficacy and Safety Study of Apremilast in Subjects With Moderate to Severe Atopic Dermatitis
NCT02087943
Sublingual Immunotherapy in Patients With Atopic Dermatitis
NCT01471119
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active
Increasing doses of RPT193 will be administered to healthy volunteers
RPT193
Antagonist of the CCR4 chemokine receptor
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo
Matching placebo will be administered to healthy volunteers
Placebo
Matching placebo
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active
Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers
RPT193
Antagonist of the CCR4 chemokine receptor
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo
Matching placebo will be administered once/day for 7 days to healthy volunteers
Placebo
Matching placebo
COMPLETED ENROLLMENT -- Expansion Part C - active
RPT193 will be administered daily for 28 days to patients with atopic dermatitis
RPT193
Antagonist of the CCR4 chemokine receptor
COMPLETED ENROLLMENT -- Expansion Part C - placebo
Matching placebo will be administered daily for 28 days to patients with atopic dermatitis
Placebo
Matching placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RPT193
Antagonist of the CCR4 chemokine receptor
Placebo
Matching placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy male or female
* 18-55 years of age, inclusive
* At least 50 kg in weight
* BMI: 18.0-30.0 kg/m2, inclusive
Part C (COMPLETED ENROLLMENT):
* Male or female with atopic dermatitis
* 18-65 years of age, inclusive
* BMI between 18.0 (inclusive) and \<40.0 kg/m2
* Body surface area (BSA) with AD involvement ≥10%
* Eczema Area and Severity Index (EASI) score ≥12
* Validated Investigator's Global Assessment (vIGA) ≥3
* History of inadequate response to treatment with topical medications, such as corticosteroids or calcineurin inhibitors, or patients for whom topical treatments are otherwise medically inadvisable
Exclusion Criteria
* Use of tobacco products within 60 days prior to drug administration
* History of alcohol abuse or drug addiction
* Positive drug and alcohol screen
* Participation in a drug study within 60 days prior to drug administration
* Donation or loss of more than 100 mL of blood within 60 days prior to drug administration.
* Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration.
Part C (COMPLETED ENROLLMENT):
* Any serious and/or uncontrolled medical condition
* History of alcohol abuse or drug addiction
* Positive drug and alcohol screen
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RAPT Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laurence Cheng, MD, PhD
Role: STUDY_DIRECTOR
RAPT Therepeutics, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Perseverance Research Center LLC
Scottsdale, Arizona, United States
University Clinical Trials, Inc
San Diego, California, United States
Lenus Research & Medical Group
Miami, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
DelRicht Research
Baton Rouge, Louisiana, United States
Clinical Trials Management,LLC
Metairie, Louisiana, United States
MetroBoston Clinical Partners LLC
Brighton, Massachusetts, United States
Sadick Research Group LLC
New York, New York, United States
Central Sooner Research
Norman, Oklahoma, United States
DermResearch, Inc.
Austin, Texas, United States
Progressive Clinical Research PA
San Antonio, Texas, United States
PRA
Groningen, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RPT193-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.