Last reviewed · How we verify

NCT04811131

Safety and Efficacy of ARQ-252 Cream 0.3% in Subjects With Non-Segmental Facial Vitiligo

Terminated Phase 2 Results posted Last updated 12 July 2024
What this trial tests

Phase 2 trial testing ARQ-252 cream 0.3% in Vitiligo in 114 participants. Terminated before completion.

Timeline
4 March 2021
Primary endpoint
9 August 2021
9 August 2021

Quick facts

Lead sponsorArcutis Biotherapeutics, Inc.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment114
Start date4 March 2021
Primary completion9 August 2021
Estimated completion9 August 2021
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Arcutis Biotherapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Vitiligo. 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.

Percentage of Change From Baseline in F-VASI Score Secondary · Weeks 4, 8, 12, 16, 20, and 24

The mean (SD) percentage change from baseline in F-VASI scores across study time points is presented. F-VASI measures the % of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (none), 10% (only specks), 25% (pigmented area \> depigmented area), 50% (depigmented and pigmented areas equal), 75% (depigmented area \> pigmented area), 90% (specks of pigment), or 100% (no pigment). F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the value

Week 4
GroupValue95% CI
Active IP and Active Phototherapy-21.009± 25.0121
Active IP and Sham Phototherapy-7.775± 11.8841
Vehicle and Active Phototherapy-11.589± 21.5439
Vehicle and Sham Phototherapy2.857± 6.3888
Week 8
GroupValue95% CI
Active IP and Active Phototherapy-57.160± 27.3703
Active IP and Sham Phototherapy-27.917± 23.4974
Vehicle and Active Phototherapy-39.570± 27.5064
Vehicle and Sham Phototherapy-16.667± 23.5702
Week 12
GroupValue95% CI
Active IP and Active Phototherapy-62.963± NA
Active IP and Sham Phototherapy-54.157± 16.7882
Vehicle and Active Phototherapy-33.333± NA
Week 16
GroupValue95% CI
Active IP and Sham Phototherapy-10.100± 55.6893

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to ~22 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active IP and Active Phototherapy
Serious: 0/34 (0%)
Deaths: 0/34
Active IP and Sham Phototherapy
Serious: 0/36 (0%)
Deaths: 0/36
Vehicle and Active Phototherapy
Serious: 0/30 (0%)
Deaths: 0/30
Vehicle and Sham Phototherapy
Serious: 0/12 (0%)
Deaths: 0/12
Other adverse events (7 terms — click to expand)

ReactionSystemActive IP and Active Photo…Active IP and Sham Phototh…Vehicle and Active Phototh…Vehicle and Sham Photother…
Oral herpesInfections and infestations
SunburnInjury, poisoning and procedural complications
Application site painGeneral disorders
Fibula fractureInjury, poisoning and procedural complications
DysguesiaNervous system disorders
AsthmaRespiratory, thoracic and mediastinal disorders
Alanine aminotransferase increasedInvestigations

Data from ClinicalTrials.gov NCT04811131 adverse events section.

Sponsor's own description

This study will assess the safety and efficacy of ARQ-252 cream in combination with NB-UVB phototherapy treatment in individuals with non-segmental facial vitiligo.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
    Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004
  2. Vitiligo: Pathogenesis and New and Emerging Treatments.
    Perez-Bootello J, Cova-Martin R, Naharro-Rodriguez J, Segurado-Miravalles G. · · 2023 · cited 36× · PMID 38139134 · DOI 10.3390/ijms242417306
  3. Exploring the Therapeutic Landscape: A Narrative Review on Topical and Oral Phosphodiesterase-4 Inhibitors in Dermatology.
    Carmona-Rocha E, Rusiñol L, Puig L. · · 2025 · cited 11× · PMID 39861739 · DOI 10.3390/pharmaceutics17010091

Verify or expand the search:

Other trials of ARQ-252 cream 0.3%

Trials testing the same drug.

Other recruiting trials for Vitiligo

Currently open trials in the same condition.

Other Arcutis Biotherapeutics, 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/NCT04811131.

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