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Compares treatment options for Vitiligo
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?
LITFULO is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for vitiligo.
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
- Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. areas of high stress.
- 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. BSA involvement between 4% and 60% inclusive, excluding involvements at palms...
- 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
- 1\. Pregnant or breast-feeding women. Or women with potential childbearing and not taking contraceptives or who plan to get pregnant 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...
- 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...
- Other immunomodulatory biologic agents or other marketed immunosuppressants.
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. BSA...
- 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
- 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...
- 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...
- 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...
- 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...
- 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.
- 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...
- Any psychiatric condition including recent or active suicidal ideation or behavior that meets any of the following criteria:
- 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.
- For adults, any lifetime history of serious suicidal behavior or recurrent suicidal behavior. For adolescents, any previous lifetime history of suicidal behavior. ii. Medical conditions pertaining to vitiligo and other...
- 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...
- Have a superficial skin infections within 2 weeks prior to first dose on Day 1. NOTE: participants may be rescreened after the infection resolves. iii. General Infection History:
- 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. NOTE: participants may be rescreened after the...
- Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium TB as evidenced by the following:
- 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.
- Assessment of the Screening chest imaging for latent or active tuberculosis is required if QFT-G is positive or T-SPOT is positive or borderline or if the participant has been previously treated for latent or active TB...
- 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.
- Hepatitis B: At Screening, hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) will be tested:
- 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 HBsAg is negative and HBcAb is positive, hepatitis B surface antibody (HBsAb) reflex testing is required:
- 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.
- Hepatitis C: At Screening, hepatitis C antibody (HCVAb) will be tested:
- 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.
- Have a known immunodeficiency disorder (including positive serology for HIV at Screening) or a first-degree relative with a hereditary immunodeficiency. v. Medical Conditions, Other:
- 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\. Patients with severe...
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Nice, Alpes-Maritime, France; Paris, Creteil, France; Bordeaux, France; La Réunion, France; Lyon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.