progressive vitiligo
Conditions
Interventions
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the pla
Sponsors
Centre Hospitalier Universitaire de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject: male or female aged = 18 years and = 75 years - Diagnosis of non-segmental (symmetrical) vitiligo with a body surface area involved >5% excluding hands and feet - Active non-segmental vitiligo is defined by: • Non-segmental vitiligo with new patches or extension of old lesions during the last 6 months AND • Presence of hypochromic aspect under Wood’s lamp examination and/or perifollicular hypopigmentation under Wood’s lamp examination. - Able to read, understand, and give documented (electronic or paper signature) informed consent - Registered in the French Social Security - Agree to discontinue the use of the following excluded medications/treatments for at least 4 weeks prior to randomization (Visit 2) and throughout the study: systemic steroids, phototherapy, methotrexate, cyclosporine, mycophenolate mofetil, and azathioprine. - Agree to discontinue the use of the following excluded medications for at least 2 weeks prior to randomization (Visit 2) and throughout the study: • TCS or topical immune modulators (e.g., tacrolimus or pimecrolimus) • Topical phosphodiesterase type 4 (PDE-4) inhibitor (crisaborole) • Topical JAK inhibitor (e.g., tofacitinib or ruxolitinib) and/or any other investigational topical treatments. - Patient characteristics - Are male or nonpregnant, nonbreastfeeding female patients, except: a. Male patients must agree to use 2 forms of birth control (1 must be highly effective, see below) while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 4 weeks following the last dose of investigational product. b. Female patients of childbearing potential must agree to use 2 forms of birth control, when engaging in sexual intercourse with a male partner while enrolled in the study and for at least 4 weeks following the last dose of investigational product. The following birth control methods are considered acceptable (the patient should choose 2 to be used with their male partner, and 1 must be highly effective): • Highly effective birth control methods: oral, injectable, or implanted hormonal contraceptives (combined estrogen/progesterone or progesterone only, associated with inhibition of ovulation); intrauterine device or intrauterine system (e.g., progestin-releasing coil); or vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate). • Effective birth control methods: condom with a spermicidal foam, gel, film, cream, or suppository; occlusive cap (diaphragm or cervical/vault caps) with a spermicidal foam, gel, film, cream, or suppository; or oral hormonal contraceptives. c. Females of nonchildbearing potential are not required to use birth control and they are defined as: • Women =60 years of age or women who are congenitally sterile, or • Women =40 and =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Segmented or mixed vitiligo - Patients who currently have or have a history of other concomitant skin conditions (e.g., psoriasis or lupus erythematosus) that could interfere with evaluations of the effect of the study drug on vitiligo - Patients who currently have a skin infection requiring treatment or who are currently being treated with topical or systemic antibiotics. Note: Patients can only be rescreened at least 4 weeks after the date of their previous screening failure and at least 2 weeks after resolution of the infection. - Patients who have severe concomitant disease that is expected to require the use of systemic steroids or otherwise interfere with study participation or require frequent active surveillance. (e.g., chronic unstable asthma). - Patients who have been treated with the following therapies: a) monoclonal antibodies (e.g. ustekinumab, omalizumab, dupilumab) for less than 5 half-lives prior to randomization. b) prior treatment with an oral JAK inhibitor (e.g., tofacitinib, ruxolitinib) c) systemic corticosteroid administered within 4 weeks prior to planned randomization or are expected to require systemic corticosteroids during the study. d) intra-articular corticosteroid injection within 4 weeks prior to the planned randomization date. e) more than 250 sessions of UV therapy. - Patients who are totally or partially unable to provide their own care (e.g., bed rest), such as being bedridden. - Patients who have uncontrolled hypertension characterized by repeated systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg while seated. - Patients who have undergone major surgery within 8 weeks prior to screening or who will require major surgery during the course of the study that, in the opinion of the investigator, would present an unacceptable risk to the patient. - Patients who are immunocompromised and, in the opinion of the investigator, would present an unacceptable risk of participating in the study. - Patients who have had one of the following events within 12 weeks prior to the screening visit: venous thromboembolic event (VTE), myocardial infarction (MI), unstable ischemic heart disease, stroke, or NYHA Stage III/IV heart failure. - Patients with a history of recurrent VTE (= 2) or who are considered at high risk of VTE by the investigator. - Patients with a history of or presenting with cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable disease that, in the opinion of the investigator, could pose an unacceptable risk with the investigational product or interfere with the interpretation of the data. - Patients who have a history of lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have an active primary or recurrent malignancy; or have been in remission from a clinically significant malignancy for less than 5 years. a) Patients with cervical carcinoma in situ that has been resected without evidence of recurrence or metastatic disease for at least 3 years may participate in the study. b) Patients with basal cell or squamous cell skin cancer that has been completely removed without evidence of recurrence for at least 3 years may participate in the study. - Patients who have a current or recent, clinically serious viral, bacterial, fungal or parasitic infection, including Note:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the combination of baricitinib (orally) 4 mg/d + UVB TL01 (twice a week) by evaluating the percentage of skin repigmentation after 36 weeks of treatment using the VASI score in patients with vitiligo.;Secondary Objective: To evaluate the efficacy of the combination of baricitinib (orally) 4 mg/d + UVB TL01 (twice a week) between inclusion, 12, 24, 36 and 48 weeks after inclusion on the following: 1.Clinical and biological safety 2.Evolution of Vitiligo Disease 3.Evolution of the activity of vitiligo 4.The impact on quality of life 5.Blood inflammatory markers 6.Skin inflammatory markers (only at inclusion, 12 and 36 weeks) ;Primary end point(s): Mean variation in percentage of the Vitiligo Area Scoring Index (VASI) score ;Timepoint(s) of evaluation of this end point: baseline and week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The clinical and biological safety of baricitinib and phototherapy will be assessed based on clinical and biological exams. 2. Evolution of vitiligo disease between baseline, week 12, 24 and 48 3. Evolution of the activity of vitiligo will be assessed by measuring the variation in percentage of the Vitiligo Signs of Activity Score (VSAS) between baseline , week 12, 24, 36 and 48 4. Evolution of quality of life will be assessed between baseline, week 12, 24, 36 and 48: 5. Blood inflammatory markers will be measured at inclusion, week 12, 24, 36 and 48 weeks using multiplex ELISA on patients’ serum 6. Skin inflammatory markers will be measured at inclusion, 12 and 36 weeks using immunofluorescence on skin biopsies, and transcriptomic analysis on skin biopsies. ;Timepoint(s) of evaluation of this end point: baseline , week 12, 24, 36 and 48 | — |
Countries
France
Contacts
Public ContactJulien SENESCHAL
Centre Hospitalier Universitaire de Bordeaux
Outcome results
None listed