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NCT05399368

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

Terminated Phase 2 Results posted Last updated 23 March 2026
What this trial tests

Phase 2 trial testing RPT193 in Atopic Dermatitis in 229 participants. Terminated before completion.

Timeline
7 June 2022
Primary endpoint
24 May 2024
24 May 2024

Quick facts

Lead sponsorRAPT Therapeutics, Inc.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment229
Start date7 June 2022
Primary completion24 May 2024
Estimated completion24 May 2024
Sites59 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

RAPT Therapeutics, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

% change in Eczema Area Severity Index (EASI) from baseline at Week 16

GroupValue95% CI
RPT193 400 mg-42.2± 7.57
RPT193 200 mg-52.3± 6.10
RPT193 50 mg-53.1± 5.56
Placebo-59.8± 5
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Secondary · 16 weeks

To evaluate the safety and tolerability of RPT193 administered orally QD for 16 weeks

GroupValue95% CI
RPT193 400 mg26
RPT193 200 mg29
RPT193 50 mg21
Placebo18

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RPT193 400 mg
Serious: 2/59 (3%)
Deaths: 0/59
RPT193 200 mg
Serious: 0/57 (0%)
Deaths: 0/57
RPT193 50 mg
Serious: 1/57 (2%)
Deaths: 0/57
Placebo
Serious: 0/56 (0%)
Deaths: 0/56

Serious adverse events (6 terms)

ReactionSystemRPT193 400 mgRPT193 200 mgRPT193 50 mgPlacebo
Appendix DisorderGastrointestinal disorders
Abdominal abscessInfections and infestations
Hepatic failureHepatobiliary disorders
PneumoniaInfections and infestations
Stevens-Johnson syndromeSkin and subcutaneous tissue disorders
HospitalisationSurgical and medical procedures
Other adverse events (6 terms — click to expand)

ReactionSystemRPT193 400 mgRPT193 200 mgRPT193 50 mgPlacebo
NauseaGastrointestinal disorders
Dermatitis atopicSkin and subcutaneous tissue disorders
Covid-19Infections and infestations
DiarrhoeaGastrointestinal disorders
Urinary tract infectionInfections and infestations
VomitingGastrointestinal disorders

Most-reported serious reactions: Appendix Disorder, Abdominal abscess, Hepatic failure, Pneumonia, Stevens-Johnson syndrome, Hospitalisation.

Data from ClinicalTrials.gov NCT05399368 adverse events section.

Sponsor's own description

Phase 2 study of RPT193 in adults with atopic dermatitis

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Modern Interventions for Pediatric Atopic Dermatitis: An Updated Pharmacologic Approach.
    Kondratuk K, Netravali IA, Castelo-Soccio L. · · 2023 · cited 5× · PMID 36534318 · DOI 10.1007/s13555-022-00868-x

Verify or expand the search:

Other trials of RPT193

Trials testing the same drug.

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

Other RAPT Therapeutics, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05399368.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing