Atopic DermatitisPhase 2NCT05399368

An Efficacy and Safety Study of RPT193 in Adults With Atopic Dermatitis

A Phase 2 study testing RPT193 in people with Atopic Dermatitis, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 59 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Phase 2 study of RPT193 in adults with atopic dermatitis Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: RPT193
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 229 participants
Where: 59 sitesin 2 countries
Study dates: 7 Jun 2022to 24 May 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

59 sites in 2 countries.

Country

City, postcode or hospital

59 sites in 2 countries

United States56 sites

Fivenson Dermatology
Ann Arbor, Michigan, 48103
Arlington Research Center Inc.
Arlington, Texas, 76011
DermResearch
Austin, Texas, 78759
DelRicht Research
Baton Rouge, Louisiana, 70809
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, 35244
Optima Research - Boardman
Boardman, Ohio, 44512
MetroBoston Clinical Partners
Brighton, Massachusetts, 02135
Schweiger Dermatology Group, PC Research Division
Columbia, Maryland, 21044
Driven Research LLC
Coral Gables, Florida, 33134
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134
Studies in Dermatology, LLC
Cypress, Texas, 77433
Dermatology Treatment and Research Center
Dallas, Texas, 75230
University Dermatology and Vein Clinic
Darien, Illinois, 60561
Palm Beach Dermatology Group
Delray Beach, Florida, 33484
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
First OC Dermatology
Fountain Valley, California, 92708
Clinical Trial Network
Houston, Texas, 77074
Indiana Clinical and Translational Sciences Institute (CTSI) Clinical Research Center
Indianapolis, Indiana, 46202
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
Forest Hills Dermatology Group
Kew Gardens, New York, 11415
Grimes Center
Los Angeles, California, 90036
Dermatology Research Associates
Los Angeles, California, 90045
Wallace Medical Group
Los Angeles, California, 90056
Skin Sciences PLLC
Louisville, Kentucky, 40217'
Skin Care Physicians of Georgia
Macon, Georgia, 31217
GSI Clinical Research
Margate, Florida, 33063
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060
Apex Clinical Research Center
Mayfield Heights, Ohio, 44124
JUVA Skin & Laser Center
New York, New York, 10022
Ichan School of Medicine at Mount Sinai
New York, New York, 10029
Markowitz Medical, PLLC
New York, New York, 10128
Velocity Clinical Research
North Hollywood, California, 91606
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117
Advanced Dermatology of the Midlands
Omaha, Nebraska, 68144
Skin Specialists PC (Schlessinger MD)
Omaha, Nebraska, 68144
The Indiana Clinical Trials Center PC
Plainfield, Indiana, 46168
Beacon Clinical Research, LLC
Quincy, Massachusetts, 02169
Health Concepts
Rapid City, South Dakota, 57702
West End Dermatology Associates
Richmond, Virginia, 23233
Integrative Skin Science and Research
Sacramento, California, 95815
St. Joseph Dermatology and Vein Clinic
Saint Joseph, Michigan, 49085
Medisearch Clinical Trials
Saint Joseph, Missouri, 64506
Progressive Clinical Research
San Antonio, Texas, 78213
Clinical Science Institute
Santa Monica, California, 90404
Georgia Skin & Cancer Clinic
Savannah, Georgia, 31419
Perseverance Research Center
Scottsdale, Arizona, 85254
Jordan Valley Dermatology Center
South Jordan, Utah, 84095
Premier Clinical Research
Spokane, Washington, 99202
Acclaim Dermatology
Sugar Land, Texas, 77479
Complete Dermatology
Sugar Land, Texas, 77479
Lenus Research & Medical Group, LLC
Sweetwater, Florida, 33172
Forcare Clinical Research
Tampa, Florida, 33613
Clinical Trials Research Institute
Thousand Oaks, California, 91320
Schweiger Dermatology Group
Verona, New Jersey, 07044
Grekin Skin Institute
Warren, Michigan, 48088
Foxhall Research Center
Washington D.C., District of Columbia, 20016

Other trials in United States

Canada3 sites

SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, L4M7G1
LEADER Research
Hamilton, Ontario, L8L 3C3
Red Maple Trials Inc.
Ottawa, Ontario, K1H 1E4

Other trials in Canada

About this study

Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis

Phase 2 study of RPT193 in adults with atopic dermatitis

Read the detailed description

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

Conditions: Atopic Dermatitis
Being tested: RPT193, Placebo
Keywords: atopic dermatitis
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
RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17
PlaceboOther
Nonactive placebo tablet

Study groups in NCT05399368
Study group	Role	What they receive
RPT193 400 mg	Experimental	RPT193 400 mg oral tablet administered daily for 16 weeks Receives: Drug: RPT193
RPT193 200 mg	Experimental	RPT193 200 mg oral tablet administered daily for 16 weeks Receives: Drug: RPT193
RPT193 50 mg	Experimental	RPT193 50 mg oral tablet administered daily for 16 weeks Receives: Drug: RPT193
Placebo	Placebo comparator	Matching placebo oral tablet administered daily for 16 weeks Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD
% change in Eczema Area Severity Index (EASI) from baseline at Week 16
Measured: 16 weeks

Secondary outcomes (1)

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
To evaluate the safety and tolerability of RPT193 administered orally QD for 16 weeks
Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 202224 May 2024

First posted1 Jun 2022
Study start7 Jun 2022
Primary completion24 May 2024
Study completion24 May 2024

Why it stopped: Study on clinical hold by FDA

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 229 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05399368
Sponsor's protocol ID: RPT193-02
Status last verified: Mar 2026
First submitted: 26 May 2022
Last updated: 23 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
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A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
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A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
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All Atopic Dermatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of RPT193 as Monotherapy in Adults With Moderate-to-Severe Atopic Dermatitis
ClinicalTrials.gov ID: NCT05399368
Acronym / sponsor ID: RPT193-02
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study on clinical hold by FDA
Enrolment: 229 participants (actual)
Lead sponsor: RAPT Therapeutics, Inc., a member of the GSK plc group of companiesIndustry (pharma, biotech, devices)
Study start: 7 Jun 2022 (actual)
Primary completion: 24 May 2024 (actual)
Study completion: 24 May 2024 (actual)
First posted: 1 Jun 2022 (actual)
Results: Posted 25 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
RPT193 400 mg	Experimental	Drug: RPT193RPT193 400 mg oral tablet administered daily for 16 weeks
RPT193 200 mg	Experimental	Drug: RPT193RPT193 200 mg oral tablet administered daily for 16 weeks
RPT193 50 mg	Experimental	Drug: RPT193RPT193 50 mg oral tablet administered daily for 16 weeks
Placebo	Placebo comparator	Other: PlaceboMatching placebo oral tablet administered daily for 16 weeks

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (9 listed)

Uncontrolled moderate-to-severe asthma
Uncontrolled diabetes
Stage III or IV cardiac failure
Severe renal condition
Major surgery within 8 weeks of screening

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
RPT193RPT193 is an antagonist of the C-C motif chemokine receptor 4 (CCR4) that inhibits CCR4-mediated chemotaxis toward both CCL22 and CCL17	Drug	RPT193 200 mg, RPT193 400 mg, RPT193 50 mg
PlaceboNonactive placebo tablet	Other	Placebo

Primary outcome

To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD
Time frame: 16 weeks
% change in Eczema Area Severity Index (EASI) from baseline at Week 16

1 secondary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 16 weeks

Results and safety

Results posted to the registry on 25 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RPT193 400 mg	59	22
RPT193 200 mg	57	29
RPT193 50 mg	57	28
Placebo	56	39

Primary outcome: To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD

Time frame: 16 weeks. Mean (Standard Deviation). Unit: Percent Change from Baseline to Week 16

Measure	RPT193 400 mg n = 59	RPT193 200 mg n = 57	RPT193 50 mg n = 57	Placebo n = 56
Value	-42.2 (7.57)	-52.3 (6.10)	-53.1 (5.56)	-59.8 (5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Approximately 16 weeks. In total, 229 participants were randomized: 57 received RPT193 50 mg, 57 received RPT193 200 mg, 59 received RPT193 400 mg, and 56 received placebo.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RPT193 400 mg	2 of 59 (3.4%)	12 of 59 (20.3%)	0 of 59
RPT193 200 mg	0 of 57 (0%)	7 of 57 (12.3%)	0 of 57
RPT193 50 mg	1 of 57 (1.8%)	5 of 57 (8.8%)	0 of 57
Placebo	0 of 56 (0%)	4 of 56 (7.1%)	0 of 56

Limitations and caveats (from the sponsor): A limitation of the study is the small sample size due to the early termination of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Atopic Dermatitis

Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis

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.

The record lists no contact. Use the official record to reach the sponsor.

59 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RPT193 in people with Atopic Dermatitis, run by RAPT Therapeutics, Inc., a member of the GSK plc group of companies at 59 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?

The sponsor lists 8 inclusion and 9 exclusion criteria. 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: stopped early, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

To Evaluate the Clinical Efficacy of RPT193 Administered Orally Once Daily (QD) for 16 Weeks to Participants With Moderate-to-severe AD (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05399368.

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 23 Mar 2026.