A Study of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB06 Versus Placebo in Adults With Moderate to Severe Non-segmental Vitiligo
The purpose of this study is to evaluate the safety and efficacy of EB06 intravenous infusion (loading dose of 20mg/kg followed by a maintenance dose of 10mg/kg) compared with placebo in adults with moderate to severe non-segmental vitiligo..
Vitiligo is a chronic autoimmune skin disorder characterized by the loss of skin pigmentation due to the destruction of melanocytes. EB06 is a fully human monoclonal antibody that binds and neutralizes CXCL10, a chemokine implicated in the trafficking of anti-melanocytic T-cells to the epidermis and in inducing cell death. Elevated levels of CXCL10 have been associated with both the initiation of the disease and the maintenance of vitiligo lesions. The study will evaluate the safety, tolerability, and efficacy of EB06 in adults with moderate to severe non-segmental vitiligo.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Alberta
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Edmonton, Alberta, Kanada, T6H 4J8
- Ei vielä rekrytointia
- Vida Clinical Research
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Ontario
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Guelph, Ontario, Kanada, N1L 0B7
- Ei vielä rekrytointia
- Guelph Dermatology Research
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Newmarket, Ontario, Kanada, L3Y 5G8
- Ei vielä rekrytointia
- Clear Skin Dermatology
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Toronto, Ontario, Kanada, M4E 1R7
- Rekrytointi
- FACET Dermatology
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Ottaa yhteyttä:
- Dr. Yadav
- Puhelinnumero: 416-698-5521
- Sähköposti: research@facetdermatology.com
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Panama City, Panama
- Ei vielä rekrytointia
- CURAEX
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 5% total BSA, and ≥ 4 T-VASI.
- Men and women ≥ 18 years of age at the time of consent.
- Subjects who agree to discontinue all agents used to treat vitiligo from screening through to Week 28. Over the counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
- Female subjects of childbearing potential and at risk for pregnancy: negative pregnancy test and agreement to use at least one method of effective contraception throughout the study and for at least 12 weeks after the last dose of assigned treatment.
- Male subjects with female partners of childbearing potential agree to use at least one method of effective contraception by yourself or your partner, as applicable, during study duration and for at least 12 weeks after the last dose of assigned treatment.
Exclusion Criteria:
- Subjects with more than 30% of poliosis within facial vitiligo areas.
- Other forms of vitiligo (e.g., segmental) or other hypopigmentation disorders (including but not limited to tinea versicolor, piebaldism, pityriasis alba, post-inflammatory hypopigmentation, nevus anemicus, nevus depigmentosus, senile leukoderma, chemical/drug-induced leukoderma, tuberous sclerosis, etc.).
- Subjects who have used permanent depigmentation treatments, such as monobenzone, for past treatment of vitiligo. Note: prior use of hydroquinone is not prohibited (as it is a bleaching agent, not a depigmentation treatment).
- Subjects who have used topical treatments applied on vitiligo affected areas such as corticosteroids, calcineurin inhibitors, phosphodiesterase-4 inhibitor, retinoids or JAK inhibitors within 1 week prior to Day 1.
- Subjects who have used systemic immunomodulators (other than biologics, e.g., methotrexate, cyclosporin, corticosteroids, JAK inhibitors), and/or melanocyte stimulating pharmaceuticals (e.g. afamelanotide) that could affect vitiligo, or treatments that would increase skin sensitivity to ultraviolet (UV) light (e.g. 8 methoxypsoralen) within 4 weeks prior to Day 1.
- Subjects who have used laser or light-based vitiligo treatments within 4 weeks prior to Day 1.
- Subjects who have used any biological agent or experimental procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longest) prior to Day 1.
- Pregnant and/or breastfeeding subjects.
- Subjects of childbearing potential who are unwilling or unable to use one method of contraception as outlined in this protocol for the duration of the study and for at least 12 weeks after the last dose of investigational product.
- Subjects who have a known history of being inadequately treated for chronic infectious disease (e.g. hepatitis B or C, human immunodeficiency virus).
- Current or recent history (< 30 days) of a clinically meaningful bacterial, fungal, or parasitic infection.
- Subjects with a history of malignancy in the past 5 years, except for the following adequately treated, nonmetastatic malignancies: basal cell skin cancer not involving areas with vitiligo, squamous cell carcinomas of the skin not involving areas with vitiligo, or in situ cervical cancer.
- Subjects with other active coexisting skin (e.g. rosacea, melasma, psoriasis) and non-skin autoimmune diseases (e.g. multiple sclerosis, etc.) which in the investigator's opinion interferes with vitiligo assessments or poses a safety risk.
- Subjects with a history of eczema herpeticum.
- Clinically significant findings or conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations, pose a risk to subject safety during the study, or require treatment with an interfering therapy.
- Subjects with known allergy or reaction to any component of the study formulation.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Placebo Comparator: Plasebo
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Placebo IV |
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Kokeellinen: EB06
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EB06 IV loading 20 mg/kg followed by 10 mg/kg |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Mean percent change from baseline in F-VASI at Week 28
Aikaikkuna: 28 Weeks
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The Facial Vitiligo Area Scoring Index (F-VASI) is a validated assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement. The primary endpoint is the mean percent change from baseline in F-VASI at Week 28. A greater reduction from baseline reflects greater improvement in facial vitiligo. |
28 Weeks
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Mean percent change from baseline in F-VASI at Weeks 24 and 32
Aikaikkuna: Weeks 24 and 32
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Difference in mean change from baseline in F-VASI. F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement. |
Weeks 24 and 32
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Proportion of subjects achieving F VASI50 at Weeks 24, 28 and 32.
Aikaikkuna: Weeks 24, 28, and 32
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Proportion of subjects achieving at least 50% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI). F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement. |
Weeks 24, 28, and 32
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Time to achieving F-VASI50
Aikaikkuna: Baseline through Week 32
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Time from baseline to first achievement of at least 50% improvement from baseline in F-VASI. F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement. |
Baseline through Week 32
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Mean percent change from baseline in the T-VASI at Weeks 24, 28 and 32.
Aikaikkuna: Weeks 24, 28, and 32
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Mean percent change from baseline in Total Body VASI (T-VASI). T-VASI is a measure of total body vitiligo extent and depigmentation severity, with scores ranging from 0 to 100, where higher scores indicate greater vitiligo involvement. |
Weeks 24, 28, and 32
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Proportion of subjects achieving T VASI50 at Weeks 24, 28 and 32.
Aikaikkuna: Weeks 24, 28, and 32
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Proportion of subjects achieving at least 50% improvement from baseline in Total Vitiligo Area Scoring Index (T-VASI). T-VASI is a measure of total body vitiligo extent and depigmentation severity, with scores ranging from 0 to 100, where higher scores indicate greater vitiligo involvement. |
Weeks 24, 28, and 32
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Proportion of subjects achieving F-VASI75 at Weeks 24, 28 and 32.
Aikaikkuna: Weeks 24, 28, and 32
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Proportion of subjects achieving at least 75% improvement from baseline in Facial Vitiligo Area Scoring Index (F-VASI). F VASI is an assessment of the extent and degree of depigmentation affecting the face with scores ranging from 0 to 3.5, where higher scores indicate greater facial vitiligo involvement. |
Weeks 24, 28, and 32
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Proportion of subjects achieving a score of 4 (a lot less noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS) at Weeks 24, 28 and 32.
Aikaikkuna: Weeks 24, 28, and 32.
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Proportion of subjects achieving a VNS score of 4 (a lot less noticeable) or 5 (no longer noticeable) VNS is a patient-reported 5-point assessment of how noticeable facial vitiligo appears compared with before treatment, where a score of 1 indicates "more noticeable" and a score of 5 indicates "no longer noticeable. |
Weeks 24, 28, and 32.
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Time to achieving a score of 4 (a lot less noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS).
Aikaikkuna: Baseline through Week 32
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Time from baseline to first achievement of a VNS score of 4 or 5. VNS is a patient-reported 5-point assessment of how noticeable facial vitiligo appears compared with before treatment, where a score of 1 indicates "more noticeable" and a score of 5 indicates "no longer noticeable. |
Baseline through Week 32
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Proportion of subjects achieving a Face Patient Global Impression of Change-Vitiligo (F-PaGIC-V) score of 1, 2, or 3 at Weeks 24, 28, and 32.
Aikaikkuna: Weeks 24, 28, and 32
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Proportion of subjects achieving a Face Patient Global Impression of Change-Vitiligo (F-PaGIC-V) score of 1, 2, or 3. F-PaGIC V (Facial Patient Global Impression of Change-Vitiligo) is a patient-reported assessment of change in facial vitiligo since baseline using a 7-point scale ranging from 1 (very much improved) and 7 (very much worse). |
Weeks 24, 28, and 32
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Proportion of subjects achieving a Total Patient Global Impression of Change-Vitiligo (T-PaGIC-V) score of 1, 2, or 3 at Weeks 24, 28, and 32.
Aikaikkuna: Weeks 24, 28, and 32
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Proportion of subjects achieving a Total Patient Global Impression of Change-Vitiligo (T-PaGIC-V) score of 1, 2, or 3. T-PaGIC V (Total Patient Global Impression of Change-Vitiligo) is a patient-reported assessment of change in overall body vitiligo since baseline using a 7-point scale ranging from 1 (very much improved) and 7 (very much worse). |
Weeks 24, 28, and 32
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Proportion of subjects achieving a facial static investigator global assessment (F-sIGA) of 0 or 1, with at least a 2-point reduction from baseline at Week 24, 28 and Week 32.
Aikaikkuna: Weeks 24, 28, and 32
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Proportion of subjects achieving a facial static investigator global assessment (F-sIGA) of 0 or 1, with at least a 2-point reduction from baseline. F-sIGA (Facial Static Investigator Global Assessment) is an investigator-assessed measure of facial vitiligo severity using a 5-point scale of ranging from 0 (clear) to 4 (severe vitiligo). |
Weeks 24, 28, and 32
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Proportion of subjects achieving a total body static investigator global assessment (T-sIGA) of 0 or 1, with at least a 2-point reduction from baseline at Week 24, 28 and Week 32.
Aikaikkuna: Weeks 24, 28, and 32
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Proportion of subjects achieving a total body static investigator global assessment (T-sIGA) of 0 or 1, with at least a 2-point reduction from baseline. T-sIGA (Total Static Investigator Global Assessment) is an investigator-assessed measure of overall body vitiligo severity using a 5-point scale ranging from 0 (clear) to 4 (severe vitiligo). |
Weeks 24, 28, and 32
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Mean percent change from baseline in Body Surface Area (BSA) affected with depigmentation at Week 24, 28 and Week 32.
Aikaikkuna: Weeks 24, 28, and 32
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Mean percent change from baseline in Body Surface Area (BSA) affected with depigmentation. BSA is an investigator-assessed measure of the percentage of total body surface area affected by vitiligo and reflects the extent of disease involvement. |
Weeks 24, 28, and 32
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