Evaluation of Effect and Tolerance of the Association of Baricitinib and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

NCT04822584 | Completed Phase 2 DMC

• 2 other identifiers: CHUBX 2019/212020-005079-12
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this phase 2 study is to evaluate the effect and the safety of the combination of Baricitinib in combination with phototherapy in adult participants with non-segmental progressive vitiligo.

Conditions

Vitiligo

Keywords

vitiligo; phototherapy; baricitinib; randomized

Outcome Measures

Primary Outcomes (1)

• Score with Vitiligo Area Scoring Index (VASI)

  The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.

  week 36

Secondary Outcomes (27)

• Score with VASI score

  week 12

• Score with VASI score

  week 24

• Score with VASI score

  week 48

• Evaluation of Face Vitiligo Aera Scoring Index (F-VASI) score

  week 12

• Evaluation of Face Vitiligo Aera Scoring Index (F-VASI) score

  week 24

Study Arms (2)

Phototherapy associated with active treatment

EXPERIMENTAL

Baricitinib 4 mg/day orally for 36 weeks + UVB TL01: 2 times a week during 24 weeks. (Phototherapy will be started 12 weeks after the beginning of baricitinib)

Drug: Baricitinib Oral Product

Phototherapy associated with placebo

PLACEBO COMPARATOR

Placebo once a day orally for 36 weeks + UVB TL01: 2 times a week during 24 weeks. (Phototherapy will be started 12 weeks after the beginning of placebo of baricitinib).

Drug: Placebo

Interventions

Baricitinib Oral Product DRUG

Baricitinib 4 mg/day orally for 36 weeks

Phototherapy associated with active treatment

Placebo DRUG

Placebo once a day orally for 36 weeks

Phototherapy associated with placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject: male or female aged ≥ 18 years and ≤ 75 years
• Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved \>5% excluding hands and feet
• Active non-segmental vitiligo is defined by:
• Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND
• Presence of hypochromic aspect under Wood's lamp examination and/or perifollicular hypopigmentation under Wood's lamp examination.
• Able to read, understand, and give documented (electronic or paper signature) informed consent
• Registered in the French Social Security
• Agree to discontinue the use of the following excluded medications/treatments for at least 4 weeks prior to randomization (Visit 2) and throughout the study: systemic steroids, phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine.
• Agree to discontinue the use of the following excluded medications for at least 2 weeks prior to randomization (Visit 2) and throughout the study:
• TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus)
• Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole)
• Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other investigational topical treatments.
• Patient characteristics
• Are male or nonpregnant, nonbreastfeeding female patients, except:
• Male patients must agree to use 2 forms of birth control (1 must be highly effective, see below) while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 4 weeks following the last dose of investigational product.

You may not qualify if:

• Segmental or mixed vitiligo
• Patients that are currently experiencing or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus) that would interfere with evaluations of the effect of study medication on vitiligo
• Patients who are currently experiencing a skin infection that requires treatment, or who are currently being treated with topical or systemic antibiotics.
• Note: Patients may not be rescreened until at least 4 weeks after the date of their previous screen failure and at least 2 weeks after resolution of the infection.
• Patients that have any serious concomitant illness that is anticipated to require the use of systemic corticosteroids or otherwise interfere with study participation or require active frequent monitoring. (e.g., unstable chronic asthma).
• Patients that have been treated with the following therapies:
• Monoclonal antibody (e.g., ustekinumab, omalizumab, dupilumab) for less than 5 half-lives prior to randomization.
• Received prior treatment with any oral JAK inhibitor (e.g., tofacitinib,ruxolitinib)
• Received any systemic corticosteroid administered within 4 weeks prior to planned randomization or are anticipated to require systemic corticosteroids during the study.
• Have had an intra-articular corticosteroid injection within 4 weeks prior to planned randomization.
• Have received more than 250 sessions of UV lights therapies.
• Patients that are largely or wholly incapacitated permitting little or no self-care, such as being bedridden.
• Patients that have uncontrolled arterial hypertension characterized by a repeated systolic blood pressure \>160 mm Hg or diastolic blood pressure \>100 mm Hg in a seated position.
• Patients that have had any major surgery within 8 weeks prior to screening or that will require major surgery during the study that, in the opinion of the investigator, would pose an unacceptable risk to the patient.
• Patients that are immunocompromised and, in the opinion of the investigator, at an unacceptable risk for participating in the study.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (4)

Service de Dermatologie - Hôpital Saint-André

Bordeaux, Bordeaux, 33075, France

Location

Service de dermatologie - Hôpital Henri Mondor - EA EpiDermE (Epidémiologie en Dermatologie et Evaluation des Thérapeutiques)

Créteil, 94010, France

Location

Centre Hospitalier Universitaire de Nice - Service de Dermatologie

Nice, 06000, France

Location

Service de dermatologie Centre de Référence des Maladies Rares de la Peau et des muqueuses d'origine génétique - Hôpital Larrey

Toulouse, 31059 cedex 9, France

Location

Related Publications (1)

• Seneschal J, Guyon M, Merhi R, Mazereeuw-Hautier J, Andreu N, Cazenave S, Ezzedine K, Passeron T, Boniface K. Combination of Baricitinib and Phototherapy in Adults With Active Vitiligo: A Randomized Clinical Trial. JAMA Dermatol. 2025 Apr 1;161(4):375-382. doi: 10.1001/jamadermatol.2024.5737.

  PMID: 39841460 DERIVED

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

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

Study Officials

• Julien Seneschal, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study. To preserve the blinding of the study, a minimum number of sponsor personnel will see the randomization table and treatment assignments before the study is complete. All study assessments will be performed by study personnel who are blinded to the patient's treatment group. Except in clinical circumstances where unblinding is required, the patients, investigators, sponsor study team, and any personnel interacting directly with patients or investigative sites will remain blinded to baricitinib and placebo assignment until after completion of the Double-Blinded Treatment Period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multicenter, randomized, non-comparative, phase II proof-of-concept trial involved patients with progressive vitiligo and uses one of the most common regimens in this phase of study. Assessment of the experimental treatment efficacy will be estimated only on the results obtained in the experimental treatment arm (baricitinib 4 mg/day + narrowband UVB TL01 arm).

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: July 16, 2021
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: May 12, 2026

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)