CompletedPhase 2

Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO

France80 participantsStarted 2017-03-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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

What they're measuring

Score VASI

Timeframe: at 24 weeks

Trial details

NCT IDNCT03036995

SponsorCentre Hospitalier Universitaire de Nice

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-08

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