The purpose of this phase 2 study is to evaluate the effect and the safety of the combination of Baricitinib in combination with phototherapy in adult participants with non-segmental progressive vitiligo.
Treatment Strategy: Multicentric, parallel double blind randomized phase 2 prospective study comparing baricitinib (4mg/day) + narrowband UVB TL01 versus placebo + narrowband UVB TL01 Follow-up of the study: patients included in this study will start Baricitinib 3 months before starting narrowband UVB TL01. Phototherapy will be performed twice a week during 6 months. Follow-up visit will be done at week 12, 24, 36 and 48.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
49
Baricitinib 4 mg/day orally for 36 weeks
Placebo once a day orally for 36 weeks
Service de Dermatologie - Hôpital Saint-André
Bordeaux, Bordeaux, France
Service de dermatologie - Hôpital Henri Mondor - EA EpiDermE (Epidémiologie en Dermatologie et Evaluation des Thérapeutiques)
Créteil, France
Centre Hospitalier Universitaire de Nice - Service de Dermatologie
Nice, France
Service de dermatologie Centre de Référence des Maladies Rares de la Peau et des muqueuses d'origine génétique - Hôpital Larrey
Toulouse, France
Score with Vitiligo Area Scoring Index (VASI)
The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Time frame: week 36
Score with VASI score
Change in percentage of repigmented Surface area 12 weeks after-inclusion, by using the VASI score at week 12. The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Time frame: week 12
Score with VASI score
Change in percentage of repigmented Surface area 24 weeks after-inclusion, by using the VASI score at week 24. The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
Time frame: week 24
Score with VASI score
Change in percentage of repigmented Surface area 48 weeks after-inclusion, by using the VASI score at week 48. The VASI Score is used to assess the severity and extent of Vitilgo. VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study.
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Time frame: week 48
Evaluation of Face Vitiligo Aera Scoring Index (F-VASI) score
Mean variation in percentage of Face Vitiligo Aera Scoring Index (F-VASI) score between baseline , week 12
Time frame: week 12
Evaluation of Face Vitiligo Aera Scoring Index (F-VASI) score
Mean variation in percentage of Face Vitiligo Aera Scoring Index (F-VASI) score between baseline , week 24
Time frame: week 24
Evaluation of Face Vitiligo Aera Scoring Index (F-VASI) score
Mean variation in percentage of Face Vitiligo Aera Scoring Index (F-VASI) score between baseline , week 36
Time frame: week 36
Evaluation of Face Vitiligo Aera Scoring Index (F-VASI) score
Mean variation in percentage of Face Vitiligo Aera Scoring Index (F-VASI) score between baseline , week 48
Time frame: week 48
Number of Adverse Events (AE) and serious adverse events (SAE), as well as the proportion of discontinuation due to AEs and/or SAEs
AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related, that occurs after a subject provides informed consent. Abnormal laboratory values or test results occurring after informed consent constitute AEs only if they induce clinical signs or symptoms, are considered clinically meaningful, require therapy, or require changes in the study drug.
Time frame: week 36
Evaluation of score Vitiligo European Task Force (VETF)
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening \<30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
Time frame: Week 12
Evaluation of score Vitiligo European Task Force (VETF)
Variation of the score Vitiligo European Task Force (VETF) The VETF score is used to assess the severity and extent of vitiligo. The VETF assesses 3 dimensions of the disease in 5 areas (Head/neck, hands and feet, trunk, arms, legs) namely 1/ extent: percentage of vitiligo involvement estimated using the rule of nines, 2/ depigmentation severity grading (stage 0: normal pigmentation Stage 1: incomplete pigmentation , stage 2 complete depigmentation, stage 3: partial hair whitening \<30% stage 4: complete hair whitening) and 3/ spreading (score O: similar limits, Score 1: progressive vitiligo; score -1: regressive vitiligo).
Time frame: Week 24
Evaluation of score of the Vitiligo Extent Score (VES)
Variation in percentage of the Vitiligo Extent Score (VES). The VES score is used to assess the severity and extent of vitiligo. Using the VES calculator www.vitiligo-calculator.com, investigator choose the pictures that best represent the patient's skin lesions and then the percentage of depigmented area is calculated.
Time frame: Week 36
Evaluation of score of the Vitiligo Extent Score (VES)
Variation in percentage of the Vitiligo Extent Score (VES). The VES score is used to assess the severity and extent of vitiligo. Using the VES calculator www.vitiligo-calculator.com, investigator choose the pictures that best represent the patient's skin lesions and then the percentage of depigmented area is calculated.
Time frame: Week 48
Evaluation of score of the Vitiligo Signs of Activity Score (VSAS)
Variation in percentage of the Vitiligo Signs of Activity Score (VSAS). The VSAS score is used to assess the activity of the disease. It is assessed by evaluating the number of location with at least one disease sign of activity.
Time frame: Week 12
Evaluation of score of the Vitiligo Signs of Activity Score (VSAS)
Variation in percentage of the Vitiligo Signs of Activity Score (VSAS). The VSAS score is used to assess the activity of the disease. It is assessed by evaluating the number of location with at least one disease sign of activity.
Time frame: Week 24
Evaluation of score of the Vitiligo Signs of Activity Score (VSAS)
Variation in percentage of the Vitiligo Signs of Activity Score (VSAS). The VSAS score is used to assess the activity of the disease. It is assessed by evaluating the number of location with at least one disease sign of activity.
Time frame: Week 36
Evaluation of score of the Vitiligo Signs of Activity Score (VSAS)
Variation in percentage of the Vitiligo Signs of Activity Score (VSAS). The VSAS score is used to assess the activity of the disease. It is assessed by evaluating the number of location with at least one disease sign of activity.
Time frame: Week 48
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Time frame: week 12
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Time frame: week 24
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Time frame: week 36
Evaluation of score of the Dermatology Life Quality Index (DLQI)
Variation of the score of the Dermatology Life Quality Index (DLQI). DLQI is a 10-item instrument, each item scored from 0 to 3 where higher scores correspond to worse symptom impact, full range from 0 to 30.
Time frame: week 48
Evaluation of the score of the Skindex 29
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Time frame: Week 12
Evaluation of the score of the Skindex 29
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Time frame: Week 24
Evaluation of the score of the Skindex 29
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Time frame: Week 36
Evaluation of the score of the Skindex 29
Variation of the score of the Skindex 29. SkinDex29 is a 30-item instrument, each item scored from 1 to 5 where higher scores correspond to worse symptom impact, full range from 0 to 150.
Time frame: Week 48
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Expression of IFN-α, TNF-α, IFN-γ, IL-4, IL-5, IL-12, IL-13, IL-15, IL-17, IL-22, IL-23, IL-33 CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, soluble HSP70.
Time frame: day 1
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Expression of IFN-α, TNF-α, IFN-γ, IL-4, IL-5, IL-12, IL-13, IL-15, IL-17, IL-22, IL-23, IL-33 CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, soluble HSP70.
Time frame: week 12
Evaluation of blood inflammatory markers using immunofluorescence on skin biopsies and ELISA multiplex.
Expression of IFN-α, TNF-α, IFN-γ, IL-4, IL-5, IL-12, IL-13, IL-15, IL-17, IL-22, IL-23, IL-33 CXCL4, CXCL9, CXCL10, CXCL11, CXCL12, CXCL16, CCL20, soluble HSP70.
Time frame: week 36