Vitiligo study: LITFULO
Official title Combination Approach With Ritlecitinib and nbUVB Compared to Ritlecitinib Alone for Treating Vitiligo
ClinicalTrials.gov ID: NCT07152626
What this study is testing
What is LITFULO?
an investigational oral medicine being studied as a potential treatment for vitiligo is designed to inhibit JAK3 and TEC kinases, which may reduce immune‑mediated skin depigmentation
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding narrowband UVB light to ritlecitinib improves skin repigmentation compared to ritlecitinib alone after 52 weeks.
- Who it's for
- Adults who have active or stable non‑segmental vitiligo.
- What's involved
- Participants take an oral pill (ritlecitinib 100 mg daily). Some also receive narrowband UVB light treatments twice a week. They attend regular clinic visits, give blood samples, and may have optional skin biopsies.
- Time commitment
- The treatment lasts 52 weeks with clinic visits at screening, weeks 4, 12, 24, 36, 52 and a final visit at week 72 (total of 8 visits).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Men and women with non-segmental vitiligo. 2. Age ≥ 18 age old 3.
- 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...
You likely can't join if
- 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...
- Other immunomodulatory biologic agents or other marketed immunosuppressants.
- IL12/23 inhibitor (eg, ustekinumab)
- Infliximab;
See the full eligibility criteria
Who can join
- 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.
- 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.
What rules you out
- 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.
- Other immunomodulatory biologic agents or other marketed immunosuppressants.
- IL12/23 inhibitor (eg, ustekinumab)
- Infliximab;
- Adalimumab;
- Golimumab
- 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.
- 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...
- 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.
- Suicidal ideation associated with actual intent and a method or plan in the past year: "Yes" answers on items 4 or 5 of the C-SSRS administered at the Screening visit (see Appendix 6).
- Previous history of suicidal behaviors in the past 5 years: "Yes" answer (for events that occurred in the past 5 years) to any of the suicidal behavior items of the C-SSRS.
- Participants that have other types of vitiligo that do not meet criteria for active or stable vitiligo as noted in inclusion criterion #2 (including, but not limited to, segmental vitiligo and mixed vitiligo).
- Currently have active forms of other disorders of pigmentation (including but not limited to Vogt-Koyanagi-Harada disease, malignancy-induced hypopigmentation [melanoma and mycosis fungoides], post-inflammatory...
- Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions (for example, morphea, discoid lupus, leprosy, syphilis, psoriasis, seborrheic dermatitis) at the time of the Screening or...
- Having a history of systemic infection requiring hospitalization, parenteral antimicrobial, antiviral (including biologic treatment), antiparasitic, antiprotozoal, or antifungal therapy, or as otherwise judged...
- Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1.
- IGRA test: a positive QFT-G during Screening (completed by central laboratory) or a positive or borderline T-SPOT®TB (performed at local laboratory in Japan, China or those countries where local guidance require...
- A positive QFT-G test or positive or borderline T-SPOT®TB (T-SPOT test) performed within 12 weeks prior to Screening.
- History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
- Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.
- If both tests are negative, the participant is eligible for study inclusion.
- If HBsAg is positive, the participant must be excluded from participation in the study.
- If HBsAb is negative, the participant must be excluded from participation in the study; OR
- If HBsAb is positive, the participant is eligible for study inclusion.
- Participants who are HCVAb negative are eligible.
- Participants who are HCVAb positive will be reflex-tested for hepatitis C (HCV) RNA. Participants who are positive for HCVAb and HCV RNA will not be eligible for this study.
- Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal...
- History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
- Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that...
- Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- Abnormal findings on the screening chest imaging (eg, chest x-ray) that may increase the risk associated with study participation including, but not limited to, presence of active TB, general infections, cardiomyopathy...
- Long QT Syndrome, a family history of Long QT Syndrome, or a history of TdP.
- Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery or with elective surgery scheduled to occur during the study. 15\.
The study team makes the final eligibility decision.
Where it is enrolling
- Nice, Alpes-Maritime, France
- Paris, Creteil, France
- Bordeaux, France
- La Réunion, France
- Lyon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nice, Alpes-Maritime, France; Paris, Creteil, France; Bordeaux, France; La Réunion, France; Lyon, France. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.