Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO RAPID VITILIGO

Plain English Summary

Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO is a Phase 2 clinical trial sponsored by Centre Hospitalier Universitaire de Nice studying Vitiligo. This study tests if a drug called apremilast, combined with light therapy (narrowband UVB), can help skin regain color in people with vitiligo. It is for adults with non-segmental vitiligo that affects at least 10% of their body surface area. Participants will receive light therapy twice a week for 24 weeks, and either apremilast or a placebo (a dummy pill). Alternatives include other light therapies, topical creams, or systemic medications, depending on the severity and extent of vitiligo. The trial aims to enroll 80 participants.

Official 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). Observat

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults with non-segmental vitiligo covering at least 10% of their body surface area. Individuals who require light therapy treatment for their vitiligo. Patients must use effective contraception if of childbearing potential. Cannot have segmental or mixed vitiligo, other major uncontrolled health conditions, or a history of certain allergies or immune deficiencies. This trial is studying Vitiligo, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how much the skin's color returns, assessed by a score called VASI, after 24 weeks of treatment, indicating the treatment's effectiveness in restoring skin pigment. The specific primary outcome measures are: Score VASI (at 24 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses the need for more effective treatments for vitiligo, a condition that causes skin depigmentation, by investigating a new combination therapy. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Vitiligo, where improved treatment options are needed.

Investor Insight

This trial explores apremilast, a known drug for other inflammatory conditions, as a potential treatment for vitiligo, a condition affecting a significant portion of the population, suggesting a poten Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of apremilast and light therapy for your specific vitiligo. Understand that participation involves regular clinic visits for light therapy sessions and taking study medication. Be prepared for potential side effects and the need for effective contraception if you are of childbearing potential. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 80 participants

Interventions

• DRUG: Apremilast — 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.
• OTHER: Placebo — 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.

Primary Outcomes

• Score VASI (at 24 weeks)

Secondary Outcomes

• Score VETF (at 24 weeks)
• Score VE (at 24 weeks)

Full Eligibility Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

1. Segmental or mixed vitiligo
2. 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.
3. Any condition which would place the subject at unacceptable risk if he/she were to participate in the study.
4. Any condition that confounds the ability to interpret data from the study.
5. Pregnant or breast feeding, pregnancy urinary tests will be performed (see Annex 5 for details about pregnancy testing and contraception)
6. History of allergy to any component of apremilast
7. History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (eg, common variable immunodeficiency disease)
8. Active substance abuse or a history of substance abuse within 6 months prior to Screening
9. 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.
10. 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)
11. Evidence of skin conditions that would interfere with clinical assessments
12. Topical therapy within 2 weeks of randomization
13. Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources
14. Prior treatment with apremilast
15. Use of phototherapy within 4 weeks prior to randomization (ie, UVB, PUVA)
16. Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half-lives,
17. Patients assessed to be uncooperative
18. Participants in other clinical studies
19. Vulnerable people: pregnant or breast-feeding women (an urinary pregnancy test will be realized in every visit), minors, adults under guardianship or guardianship, deprived of freedom
20. Patient with a rare hereditary disease such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome
21. Patient with severe renal insufficiency

Trial Locations

• CHU de Nice - Dermatologie - Hôpital Archet, Nice, Alpes-Maritimes, France

Frequently Asked Questions

Related Conditions

• Vitiligo
• Autoimmune diseases
• Dermatology
• Inflammatory conditions
• Psoriasis
• Rheumatoid arthritis
• Skin pigmentation disorders
• Melanocyte function
• Immunology
• Dermatitis

More Vitiligo Trials

View all Vitiligo clinical trials