Atopic DermatitisPhase 1NCT04271514
A First-in-Human Study of RPT193 in Healthy Volunteers and Patients With Atopic Dermatitis
A Phase 1 study testing RPT193 in people with Atopic Dermatitis, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 14 sites in 2 countries.
Trial summary
This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind, placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and selective antagonist of CCR4. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- RPT193
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 12 Aug 2019to 26 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Selected Inclusion Criteria:
Parts A \& B (COMPLETED ENROLLMENT):
- 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
Selected Exclusion Criteria:
Parts A \& B (COMPLETED ENROLLMENT):
- 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
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
DermResearch, Inc.
Austin, Texas, 78759
DelRicht Research
Baton Rouge, Louisiana, 70809
MetroBoston Clinical Partners LLC
Brighton, Massachusetts, 02135
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Clinical Trials Management,LLC
Metairie, Louisiana, 70006
Lenus Research & Medical Group
Miami, Florida, 33172
Sadick Research Group LLC
New York, New York, 10075
Central Sooner Research
Norman, Oklahoma, 73071
Progressive Clinical Research PA
San Antonio, Texas, 78213
University Clinical Trials, Inc
San Diego, California, 92123
Perseverance Research Center LLC
Scottsdale, Arizona, 85254
ForCare Clinical Research
Tampa, Florida, 33613
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Multiple-dose Escalation, and Food Effect Study of RPT193 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind, placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and selective antagonist of CCR4.
- Conditions
- Atopic Dermatitis
- Being tested
- RPT193, Placebo
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPT193Drug
Antagonist of the CCR4 chemokine receptor
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active | Experimental | Increasing doses of RPT193 will be administered to healthy volunteers Receives: Drug: RPT193 |
| COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo | Placebo comparator | Matching placebo will be administered to healthy volunteers Receives: Drug: Placebo |
| COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active | Experimental | Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers Receives: Drug: RPT193 |
| COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo | Placebo comparator | Matching placebo will be administered once/day for 7 days to healthy volunteers Receives: Drug: Placebo |
| COMPLETED ENROLLMENT -- Expansion Part C - active | Experimental | RPT193 will be administered daily for 28 days to patients with atopic dermatitis Receives: Drug: RPT193 |
| COMPLETED ENROLLMENT -- Expansion Part C - placebo | Placebo comparator | Matching placebo will be administered daily for 28 days to patients with atopic dermatitis Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Measured: up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start12 Aug 2019
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence Cheng, MD, PhD, Study director, RAPT Therepeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271514
- Sponsor's protocol ID
- RPT193-01
- Status last verified
- Sep 2021
- First submitted
- 13 Feb 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Multiple-dose Escalation, and Food Effect Study of RPT193 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT04271514
- Acronym / sponsor ID
- RPT193-01
- Conditions
- Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- RAPT Therapeutics, Inc., a member of the GSK plc group of companiesIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind, placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and selective antagonist of CCR4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active | Experimental | Drug: RPT193Increasing doses of RPT193 will be administered to healthy volunteers |
| COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered to healthy volunteers |
| COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active | Experimental | Drug: RPT193Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers |
| COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered once/day for 7 days to healthy volunteers |
| COMPLETED ENROLLMENT -- Expansion Part C - active | Experimental | Drug: RPT193RPT193 will be administered daily for 28 days to patients with atopic dermatitis |
| COMPLETED ENROLLMENT -- Expansion Part C - placebo | Placebo comparator | Drug: PlaceboMatching placebo will be administered daily for 28 days to patients with atopic dermatitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPT193Antagonist of the CCR4 chemokine receptor | Drug | COMPLETED ENROLLMENT -- Expansion Part C - active, COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active, COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active |
| PlaceboMatching placebo | Drug | COMPLETED ENROLLMENT -- Expansion Part C - placebo, COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo, COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Cheng, MD, PhD study director
RAPT Therepeutics, Inc.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPT193 in people with Atopic Dermatitis, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.