Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO

NCT03036995 | Completed Phase 2

• 1 other identifier: 16-PP-06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Vitiligo is a depigmentation disorder affecting 0.5 to 2% of the general population. It is an acquired pigmentary disorder of the skin and mucous membranes that is characterized by circumscribed, depigmented macules and patches. Apremilast is a phosphosdiesterase 4 (PDE4) inhibitor that showed efficacy and very good tolerance in rheumatoid arthritis and psoriasis. Apremilast induces a potent activation of the cyclic AMP (cAMP) pathway leading to anti-inflammatory effect by decreasing the response of Th1 and Th17 lymphocytes. Interestingly, the cAMP pathway is also well demonstrated to be the main pathway for promoting melanogenesis and for inducing the differentiation and the proliferation of melanocytes. The principal aims is to compare, after 24 weeks of treatment, the efficacy of Apremilast at the label dosage in combination therapy with narrow band UVB versus placebo therapy with narrow band UVB for repigmentation in patients with non-segmental vitiligo. Patients with non-segmental vitiligo with BSA \> 10% and patient with Vitiligo stable or slowly progressive for 3 months , seeking for treatment in the Department of Dermatology, University Hospital of Nice, France will be recruited into the study. The Patients are seen in consultation by the investigator, selection criteria are checked. All patients will receive full body narrow UVB treatment, twice weekly sessions of narrow UVB for 24 weeks. From W24 to W48

• All responders\* will receive narrow UVB treatment according the French clinical use i.e.twice weekly sessions of narrowband UVB for 24 weeks.
• All responders\* will be randomized to receive either apremilast\*\* 30mg BID or placebo.
• Response is defined as an increase of at least 30 % in the VASI score at W24 compare to baseline \*\*Responders initially randomized in the placebo arm will benefit of the titration At week 24, the non responders patients will stop the treatment and the study after the 4 weeks observationnal follow-up (W28). Observational Follow-up Phase - W48 to W52 Four-week Observational Follow-up Phase for all subjects who complete the study (responders and non responders) or discontinue the study early.

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Score VASI

  Efficacy will be evaluated using the Vitiligo Area Scoring Index (VASI)

  at 24 weeks

Secondary Outcomes (2)

• Score VETF

  at 24 weeks

• Score VE

  at 24 weeks

Study Arms (2)

Apremilast - Group A

EXPERIMENTAL

Patient will receive narrow UVB treatment and apremilast (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and apremilast during 24 weeks.

Drug: Apremilast

Placebo - Group B

PLACEBO COMPARATOR

Patient will receive UVB treatment and placebo (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment and placebo during 24 weeks.

Other: Placebo

Interventions

Apremilast DRUG

Patient will receive narrow UVB treatment and apremilast (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and apremilast during 24 weeks.

Apremilast - Group A

Placebo OTHER

Patient will receive narrow UVB treatment and placebo (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and placebo during 24 weeks.

Placebo - Group B

Eligibility Criteria

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

You may qualify if:

• Diagnosis of non-segmental vitiligo affecting at least 10% of BSA since at least 3 months.
• Patient requiring a treatment by UVB
• For both female of childbearing potential and male patients: Use of an effective contraceptive method during the study period (see Annex 5 for details)
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted
• Able to adhere to the study visit schedule and other protocol requirements
• Patient registered to the French Social Security

You may not qualify if:

• Segmental or mixed vitiligo
• Other than vitiligo, history of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
• Any condition which would place the subject at unacceptable risk if he/she were to participate in the study.
• Any condition that confounds the ability to interpret data from the study.
• Pregnant or breast feeding, pregnancy urinary tests will be performed (see Annex 5 for details about pregnancy testing and contraception)
• History of allergy to any component of apremilast
• History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
• Active substance abuse or a history of substance abuse within 6 months prior to Screening
• Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening.
• Malignancy or history of malignancy (except for treated \[ie, cured\] basal cell or squamous cell in situ skin carcinomas and treated \[ie, cured\] cervical intraepithelial neoplasia \[CIN\] or carcinoma in situ of the cervix with no evidence of recurrence)
• Evidence of skin conditions that would interfere with clinical assessments
• Topical therapy within 2 weeks of randomization
• Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
• Prior treatment with apremilast
• Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Dermatologie - Hôpital Archet

Nice, Alpes-Maritimes, 06, France

Location

Related Publications (1)

• Khemis A, Fontas E, Moulin S, Montaudie H, Lacour JP, Passeron T. Apremilast in Combination with Narrowband UVB in the Treatment of Vitiligo: A 52-Week Monocentric Prospective Randomized Placebo-Controlled Study. J Invest Dermatol. 2020 Aug;140(8):1533-1537.e2. doi: 10.1016/j.jid.2019.11.031. Epub 2020 Jan 29.

  PMID: 32004567 RESULT

MeSH Terms

Conditions

Vitiligo

Interventions

apremilast

Condition Hierarchy (Ancestors)

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

Study Officials

• Passeron Thierry, PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 31, 2017
• Study Start: March 20, 2017
• Primary Completion: November 8, 2018
• Study Completion: November 25, 2019
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

FR (1)