💬In plain words
What the trial is, and whether it could suit you
Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. areas of high stress. Ritlecitinib, an orally administered inhibitor of JAK3 (Janus kinase)/ TEC (tyrosine kinase expressed in hepatocellular carcinoma) has shown effectiveness and safety for the treatment of vitiligo. In a phase 2b trial, three doses of ritlecitinib, 200/50 mg, 100/50 mg, and 50 mg, were all statistically significant versus placebo on the Facial Vitiligo Area Scoring Index (F-VASI) at week 24 in patients with active NSV. Considering that the immune process primarily contributes to depigmentation while ultraviolet (UV) radiation stimulates the differentiation and proliferation of melanocyte stem cells for re-pigmentation, the investigators propose that a combination therapy using ritlecitinib and narrowband UVB (nbUVB) could offer an optimal approach for tr
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 1\. Men and women with non-segmental vitiligo. 2. Age ≥ 18 age old 3. BSA involvement between 4% and 60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet 4. BSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids) 5. F-VASI ≥0.5 and T-VASI ≥3 6. Active and stable vitiligo 7. For Women of childbearing potential (WOCBP), an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study; Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result at baseline; WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives;
Women of non-childbearing potential (WONCBP) do not require a urine pregnancy test and must meet at least one of the following criteria:
o Have undergone hysterectomy or bilateral oophorectomy;
* Have medically confirmed ovarian failure; or
* Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause); 8. Affiliation to a social security system; 9. Signed informed consent.
Exclusion Criteria:
* 1\. Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant during the study duration, and 2. Segmental or mixed vitiligo, and 3. Contraindication to nbUVB phototherapy, and 4. Concomitant use of topical or systemic immunosuppressive medication or steroids, and 5. Patients treated before with oral JAK inhibitor, topical treatments (including JAK inhibitors) that could affect vitiligo (eg, corticosteroids, vitamin D3 and calcineurin inhibitor) within 2 Weeks of Day 1 (Baseline) and during the study
At any time prior to or during the study:
* Use of permanent depigmentation treatment for vitiligo and/or other types of pigmentation disorder (eg, monobenzone or phenol).
* Previous use of any systemic JAK inhibitor for any disease indication
* Any non-B cell selective lymphocyte depleting agent (eg, alefacept, alemtuzumab) and alkylating agents \[eg, cyclophosphamide or chlorambucil\], total lymphoid irradiation, etc.
* History of MKTP or other surgical treatment for vitiligo.
Within 6 months of the first dose of study drug or 5 half-lives (if known), or until lymphocyte count returns to normal, whichever is longer and during the study:
\- Any B-cell-depleting agents including but not limited to rituximab or previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange.
Within 12 weeks of first dose of study drug or 5 half-lives (if known), whichever is longer and during the study:
* Other immunomodulatory biologic agents or other marketed immunosuppressants.
* IL12/23 inhibitor (eg, ustekinumab)
* Integrin inhibitors (eg, vedolizumab)
Within 8 weeks of Day 1 and during the study:
\- Narrow-band UVB phototherapy, Psoralen Ultra-Violet A therapy, or other phototherapy.
TNF inhibitors (or biosimilars thereof) as described below:
* Infliximab;
* Adalimumab;
* Golimumab
* Interferon therapy
Within 8 Weeks of Day 1 \[Baseline\] (or within 5 half-lives, whichever is longer) and during the study:
* Systemic treatments that could affect vitiligo.
* Use of oral or intravenous immune suppressants (eg, cyclosporine A, tacrolimus, azathioprine, MTX, systemic corticosteroids, mycophenolate-mofetil, mercaptopurine (6MP), or thioguanine).
* Use of sulfasalazine.
* Intralesional, oral or injectable steroids.
Within 6 Weeks of Day 1 (Baseline), during the study, and within 6 weeks of last dose:
\- Vaccination with live attenuated, replication-competent vaccine; Current routine household contact with individuals who have been vaccinated with a live attenuated, replication-competent vaccine.
Within 4 weeks (28 Days) of first dose of study intervention or 5 half-lives (if known), whichever is longer and during the study:
* Prohibited CYP3A inducers (see Table 8).
* Herbals that are known to have an effect on drug metabolism.
* Previous administration of investigational drug(s) or vaccines that do not affect vitiligo.
Note: Any investigational or experimental therapy taken, or procedure performed for vitiligo and other autoimmune or immunologic diseases including but not limited to rheumatoid arthritis, psoriasis alopecia areata, thyroid disease, allergic rhinitis, or atopic dermatitis within the previous 1 year should be carefully evaluated. Participants cannot participate in studies of other investigational or experimental therapies or procedures at any time during their participation in this study.
Within 1 Week of Day 1 \[Baseline\] (or within 5 half-lives, whichever is longer) and during the study:
\- Herbal medications with unknown properties or known beneficial effects for vitiligo.
* Prohibited CYP3A substrates as described in Table 8.
* Investigators should consult the SRSD for ritlecitinib for information regarding medication that is prohibited for concomitant use.
* Investigators should consult the product label for any other medication used during the study for information regarding medication that is prohibited for concomitant use.
And 6. Patients suffering from photodermatosis or taking photosensitive drugs, and 7. Patients with more than 33% of leucotrichia on the lesions (Leukotrichia in more than 33% of the face surface area affected with vitiligo lesions OR leukotrichia in more than 33% of the total body surface