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

NCT04811131 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: ARQ-252-213
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 75% Reduction in Facial Vitiligo Area Scoring Index (F-VASI) Score (F-VASI75) at Week 24

  Achievement of F-VASI75 was declared with a ≥75% improvement from Baseline in F-VASI. 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 values of all sites (possible range: 0-3; lower scores indicate increased improvement).

  Week 24

Secondary Outcomes (12)

• Percentage of Change From Baseline in F-VASI Score

  Weeks 4, 8, 12, 16, 20, and 24

• Change From Baseline in Facial Body Surface Area (F-BSA) Score

  Weeks 4, 8, 12, 16, 20, and 24

• Change From Baseline in Vitiligo Noticeability Scale (VNS) Score

  Weeks 4, 8, 12, 16, 20, and 24.

• Change From Baseline in Vitiligo Quality of Life (VitiQOL)

  Weeks 4, 8, 12, 16, 20, and 24

• Change From Baseline in Patient Global Impression of Change-Vitiligo (PaGIC-V)

  Week 4, 8, 12, 16, 20, and 24

Study Arms (4)

Active IP and Active Phototherapy

ACTIVE COMPARATOR

ARQ-252 cream 0.3% BID with phototherapy.

Drug: ARQ-252 cream 0.3%; Device: NB-UVB phototherapy active treatment

Active IP and Sham Phototherapy

ACTIVE COMPARATOR

ARQ-252 cream 0.3% BID with sham phototherapy

Drug: ARQ-252 cream 0.3%; Device: NB-UVB phototherapy sham treatment

Vehicle and Active Phototherapy

PLACEBO COMPARATOR

ARQ-252 Vehicle cream BID with active phototherapy

Drug: ARQ-252 Vehicle cream; Device: NB-UVB phototherapy active treatment

Vehicle and Sham Phototherapy

PLACEBO COMPARATOR

ARQ-252 Vehicle cream BID with sham phototherapy

Drug: ARQ-252 Vehicle cream; Device: NB-UVB phototherapy sham treatment

Interventions

ARQ-252 cream 0.3% DRUG

ARQ-252 cream 0.3%

Active IP and Active Phototherapy; Active IP and Sham Phototherapy

ARQ-252 Vehicle cream DRUG

ARQ-252 Vehicle cream

Vehicle and Active Phototherapy; Vehicle and Sham Phototherapy

NB-UVB phototherapy active treatment DEVICE

NB-UVB phototherapy active treatment

Active IP and Active Phototherapy; Vehicle and Active Phototherapy

NB-UVB phototherapy sham treatment DEVICE

NB-UVB phototherapy sham treatment

Active IP and Sham Phototherapy; Vehicle and Sham Phototherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is legally competent to sign and give informed consent.
• Males and females ages 18 years and older (inclusive)
• Clinical diagnosis of non-segmental vitiligo involving face.
• A Facial Vitiligo Area Severity Index \[F-VASI\] score of ≥ 0.25 at baseline.
• Vitiligo of the face involving at least ≥ 0.25% body surface area (BSA) involvement (ie, one quarter of one handprint). Subjects may have non-facial vitiligo elsewhere which will not be included in the minimum BSA. The maximum BSA (total body inclusive of the face, whether or not in areas to be treated in this study) permitted is 15%.
• Subjects with vitiligo on the hands, forearms, or elbows agree to treat these areas in addition to the face, with investigational product and phototherapy.
• Subject agrees to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the Investigator and camouflage makeups are permitted.
• Female subject of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline (Visit 2). For FOCBP involved in any sexual intercourse that could lead to pregnancy: the subject must agree to use a highly effective contraceptive method for at least 4 weeks prior to Day 1. Additionally, from Day 1 until at least 4 weeks after the last investigational product administration, these subjects must agree to use at least 1 highly effective contraceptive method in addition to 1 barrier method.
• Female subject of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months prior to baseline (post-menopausal status will be confirmed with FSH testing) or have undergone surgical sterilization.
• Males, if engaging in sexual intercourse with a female who is pregnant or a female of child-bearing potential, must agree to use a condom every time during the study and every time subsequently until 4 weeks beyond the last dose of investigational product.
• Males must agree not to donate sperm from the first dose of investigational product until 4 weeks after the last dose of investigational product.
• Subject is in good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.

You may not qualify if:

• Subjects who have ever used skin bleaching treatments for treatment of vitiligo or other pigmented areas, eg, depigmenting agents such as monobenzyl ether of hydroquinone, including Benoquin® (Monobenzone)
• Use of any other prior and concomitant therapy that is a contraindication to phototherapy or may otherwise interfere with the objective of the study as per discretion of the Investigator, such as drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of Baseline (Visit 2).
• More than 33% leukotrichia in facial lesions (assessed via dermatoscope).
• Other forms of vitiligo (eg, segmental vitiligo); or other skin depigmentation disorder that would confound study assessments.
• Use of oral or systemic immunomodulating medications (eg, corticosteroids, azathioprine, methotrexate, cyclosporine) within 8 weeks of Baseline (Visit 2).
• Use of prescription or over-the-counter topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids, vitamin D derivates, psoralens) within 4 weeks prior to Baseline (Visit 2).
• Use of any biological or experimental therapy for vitiligo within 24 weeks of Baseline (Visit 2) (or 5 half-lives, whichever is longer).
• Use of phototherapy (including laser and tanning beds) within 8 weeks prior to Baseline (Visit 2).
• Previous oral or topical JAK inhibitor therapy within 24 weeks prior to Baseline (Visit 2), and/or prior non-response to oral or topical JAK inhibitor therapy for vitiligo
• History of melanocyte-keratinocyte transplantation procedure (MKTP) or other surgical treatment for vitiligo.
• Contraindication to phototherapy, such as photosensitivity disorder (eg, lupus, polymorphic light eruption, solar urticaria, dermatomyositis) or use of photosensitizing or phototoxic medications.
• Subjects with clinically significant abnormal thyroid-stimulating hormone or free T4 at screening, or otherwise uncontrolled thyroid function at screening as determined by the investigator (Note: If the subject has a history of thyroid disease and is on treatment, the participant must be on a stable thyroid regimen for at least 3 months prior to baseline)
• History of chronic alcohol or drug abuse within 6 months prior to baseline.
• Subjects with a cytopenia at screening, defined as follows: Leukocytes \< 3 × 10\^9/L (2.5 × 10\^9/L for subjects who are African-American), Neutrophils \< lower limit of normal (\<1.5x10\^9/L), Lymphocytes \< 0.8 × 10\^9/L, Hemoglobin \< 10 g/dL, Platelets \< 100 × 10\^9/L.
• Subjects with current or a history of non-skin cancer within 5 years with the exception carcinoma in situ of the cervix.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (5)

Arcutis Site 123

San Diego, California, 92123, United States

Location

Arcutis Site 167

Coral Gables, Florida, 33134, United States

Location

Arcutis Clinical Site 102

Rolling Meadows, Illinois, 60008, United States

Location

Arcutis Site 162

Austin, Texas, 78759, United States

Location

Arcutis Clinical Site 163

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a parallel group, double blind, vehicle-controlled study in which subjects with non-segmental vitiligo will be randomized to ARQ-252 0.3% cream BID or vehicle cream BID, and active phototherapy or sham phototherapy for 24 weeks to affected areas of vitiligo on the face, neck, hands, forearms, and elbows, (Up to 15% total body BSA)

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 23, 2021
• Study Start: March 4, 2021
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: July 12, 2024
• Results First Posted: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)