2022-502518-98-00招募中3 期
B7981080 - A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 355
- 试验地点
- 76
- 主要终点
- Part II: Incidence of TEAEs, SAEs, and AEs leading to discontinuation
研究概览
简要总结
Part Ia:
- To compare the efficacy of ritlecitinib 100 mg QD versus placebo in participants with nonsegmental vitiligo
- To evaluate the safety and tolerability of ritlecitinib over time in participants with nonsegmental vitiligo
Part Ib: To evaluate the long-term safety and tolerability of ritlecitinib 100 mg QD, ritlecitinib 50 mg QD, and placebo in adult participants with nonsegmental vitiligo
Part II: To evaluate the safety and tolerability of ritlecitinib 100 mg QD in adult participants with nonsegmental vitiligo
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall design
- 盲法
- Double (Investigator, Subject, Carer, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must be ≥18 years of age at Screening.
- •Eligible participants must have at both Screening and BL: • A clinical diagnosis of nonsegmental vitiligo for at least 3 months; and • Body surface area (BSA) involvement between 4%-60% inclusive, excluding involvements at palms of the hands, soles of the feet, or dorsal aspect of the feet; and • BSA ≥0.5% involvement on the face (face is defined as including the area on the forehead to the original hairline, on the cheek vertically to the jawline, and laterally from the corner of the mouth to the tragus. The face will not include scalp, ears, neck, or surface area of the lips, but will include the nose and the eyelids); and • F-VASI ≥0.5 and T-VASI ≥3; and • Either active or stable nonsegmental vitiligo at both Screening and BL visits. All participants who do not have the features of active vitiligo (defined below) will be classified as having stable disease.
排除标准
- •Medical conditions pertaining to vitiligo and other diseases/conditions affecting the skin
- •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.
研究组 & 干预措施
DEXAMETHASONE
Auxiliary
干预措施: DEXAMETHASONE (Drug)
Placebo for PF-06651600-15, 100 mg, Placebo for PF-06651600-15, 50 mg
Placebo
干预措施: Placebo for PF-06651600-15, 100 mg (Drug)
Placebo for PF-06651600-15, 100 mg, Placebo for PF-06651600-15, 50 mg
Placebo
干预措施: Placebo for PF-06651600-15, 50 mg (Drug)
Ritlecitinib Tosilate, Ritlecitinib tosilate
Test
干预措施: Ritlecitinib Tosilate (Drug)
Ritlecitinib Tosilate, Ritlecitinib tosilate
Test
干预措施: Ritlecitinib tosilate (Drug)
结局指标
主要结局
Part II: Incidence of TEAEs, SAEs, and AEs leading to discontinuation
Part II: Incidence of TEAEs, SAEs, and AEs leading to discontinuation
Part II: Incidence of clinically significant laboratory abnormalities.
Part II: Incidence of clinically significant laboratory abnormalities.
Part Ia: Response based on F-VASI75 (defined as at least 75% improvement in Facial Vitiligo Area Scoring Index [F-VASI] from BL) at Week 52a
Part Ia: Response based on F-VASI75 (defined as at least 75% improvement in Facial Vitiligo Area Scoring Index [F-VASI] from BL) at Week 52a
Part Ia: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Part Ia: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation
Part Ia: Incidence of clinically significant laboratory abnormalities
Part Ia: Incidence of clinically significant laboratory abnormalities
Part Ib: Incidence of TEAEs, SAEs, and AEs leading to discontinuation
Part Ib: Incidence of TEAEs, SAEs, and AEs leading to discontinuation
Part Ib: Incidence of clinically significant laboratory abnormalities
Part Ib: Incidence of clinically significant laboratory abnormalities
Part Ia: Response based on T-VASI50 at all time points in the SoA except for those included as primary and key secondary endpointa
Part Ia: Response based on T-VASI50 at all time points in the SoA except for those included as primary and key secondary endpointa
次要结局
- Part II: Response based on PGIC-F (CCI) at all time points in the SoA
- Part Ia: Response based on PGIC-V (CCI) at Weeks 24, 36 and 52a
- Part II: Time to (CCI) use
- Part Ia: Response based on T-VASI50 at Weeks 24, 36a
- Part Ia: Response based on sustained improvement in T-VASI (CCI)a
- Part Ia: Response based on sustained improvement in F-VASI (CCI)a
- Part Ia: Time to (CCI) use
- Part Ia: Response based on PGIC-F (CCI) at Weeks 24, 36 and 52a
- Part Ia: Response based on (CCI) at Week 52 (in participants with BL HADS subscale scores indicative of depression)a
- Part Ia: Response based on (CCI) at Week 52 (in participants with BL HADS subscale scores indicative of anxiety)a
- Part Ib: Response based on improvement in PGIS-Fd at all time points in the SoAa
- Part Ib: Response based on improvement in PGIS-Ve at all time pints in the SoAa
- Part Ib: Response based on (CCI) in facial vitiligo on PGIC-F at all time points in the SoAa
- Part Ib: Response based on (CCI) in total body vitiligo on PGIC-V at all time points in the SoAa
- Part II: Response based on PGIC-V (CCI) at all time points in the SoA
- Part II: Response based on improvement in PGIS-Fb at all the time points in the SoA
- Part II: Response based on improvement in PGIS-Vc at all the time points in the SoA
- Part II: Response based on a (CCI) at Week 52 (in participants with BL HADS subscale scores indicative of depression)
- Part II: Response based on a (CCI) at Week 52 (in participants with BL HADS subscale scores indicative of anxiety)
- Part 1b: % CFB in F-VASI (relative to BL) at all time points in the SoA b
- Part 1b: % CFB in T-VASI (relative to BL) at all time points in the SoA b
- Part 1b: Response based on F-VASI100 (relative to BL) at all time points in the SoAa
- Part II: % CFB in F-VASI at all time points in the SoA
- Part II: % CFB in T-VASI at all time points in the SoA
- Part Ia: % CFB in F-VASI at Weeks 24, 36 and 52d
- Part Ia: % CFB in T-VASI at Weeks 24, 36 and 52d
- Part Ia: Response based on F-VASI75 at Weeks 24 and 36a
- Part Ia: Response based on stabilization of disease at all time points after Week 8 in the Schedule of Activities (SoA)
- Part Ia: Percent CFB in T-VASI at all time points in the SoA
- Part Ia: Response based on T-VASI90 (defined as at least 90% improvement in T-VASI from BL) at all time points in the SoA
- Part Ia: Response based on T-VASI100 (defined as 100% improvement in T-VASI from BL) at all time points in the SoA
- Part Ia: Response based on F-VASI50 (defined as at least 50% improvement in F-VASI from BL) at all time points in the SoA
- Part Ia: Response based on F-VASI75 at all time points in the SoA unless included as primary or secondary endpoints
- Part Ia: Response based on F-VASI90 (defined as at least 90% improvement in F-VASI from BL) at all time points in the SoAa
- Part Ia: Response based on F-VASI100 (defined as 100% improvement in F-VASI from BL) at all time points in the SoA
- Part Ia: Response based on improvement in PGIS-Fe at Week 36 unless included as key secondary endpoint
- Part Ia: Response based on improvement in PGIS-Vf at Week 36 unless included as key secondary endpoint
- Part Ib: Response based on F-VASI50 (relative to BL) at all time points in the SoA
- Part Ib: Response based on F-VASI90 (relative to BL) at all time points in the SoA
- Part Ib: Response based on T-VASI90 (relative to BL) at all time points in the SoA
- Part Ib: Response based on T-VASI100 (relative to BL) at all time points in the SoA
- Part Ib: Response based on improvement in PGIS-Fc at Week 104
- Part Ib: Response based on improvement in PGIS-Vd at Week 104
- Part Ib: Response based on scoring at least “moderately better” in facial vitiligo on PGIC-F at Week 104
- Part Ib: Response based on scoring at least “moderately better” in total body vitiligo on PGIC-V at Week 104
- Part II: Response based on T-VASI75 at all time points in the SoA
- Part II: Response based on F-VASI75 at all time points in the SoA
- Part II: Response based on T-VASI50 at all time points in the SoA
- Part II: Response based on stabilization of disease at all time points after Week 8 in the SoA
- Part II: Response based on sustained improvement in T- VASI
- Part II: Response based on sustained improvement in F- VASI
- Part II: Time to rescue medication use
- Part II: Percent CFB in F-VASI at all time points in the SoA
- Part II: Percent CFB in T-VASI at all time points in the SoA
- Part II: Response based on T-VASI90 at all time points in the SoA
- Part II: Response based on T-VASI100 at all time points in the SoA
- Part II: Response based on F-VASI50 at all time points in the SoA
- Part II: Response based on F-VASI90 at all time points in the SoA
- Part II: Response based on F-VASI100 at all time points in the SoA
- Part II: CFB in the HADS anxiety subscale at Week 52
- Part Ia: Response based on T-VASI50 at Weeks 24, 36, and 52a
- Part Ia: Response based on PGIC-F (defined as at least “moderately better” reported change in severity of vitiligo on the face from baseline [BL]) at Weeks 36 and 52a
- Part Ia: Response based on PGIC-V (defined as at least “moderately better” reported change in severity of total body vitiligo from BL) at Weeks 36 and 52a
- Part Ia: Response based on improvement in PGIS-Fb at Weeks 36 and 52a
- Part Ia: Response based on improvement in PGIS-Vc at Weeks 36 and 52a
- Part Ia: Response based on F-VASI75 at all time points in the SoA except for those included as primary and key secondary endpointsa
- Part Ia: Response based on T-VASI75 at all time points in the SoA except for that included as a primary endpointa
- Part Ia: Response based on sustained improvement in TVASI (defined as maintenance of ≥T-VASI50 from Week 36 to Week 52)
- Part Ia: Response based on sustained improvement in FVASI (defined as maintenance of ≥F-VASI75 from Week 36 to 52)
- Part Ia: Time to rescue medication use
- Part Ia: Percent change from baseline (CFB) in F-VASI at all time points in the SoA
- Part Ia: Response based on PGIC-F (defined as at least “moderately better” reported change in facial vitiligo from BL) at Weeks 36 and 52 unless included as key secondary endpoint
- Part Ia: Response based on PGIC-V (defined as at least “moderately better” reported change in total body vitiligo from BL) at Weeks 36 and 52 unless included as key secondary endpoint
- Part Ia: CFB in Dermatology Life Quality Index (DLQI) at Week 52
- Part Ia: CFB in the Hospital Anxiety and Depression Scale (HADS) depression subscale at Week 52
- Part Ia: CFB in the HADS anxiety subscale at Week 52
- Part Ia: Response based on a ‘normal’ subscale score indicative of an absence of depression at Week 52 (in participants with BL HADS subscale scores indicative of depression)
- Part Ia: Response based on a ‘normal’ subscale score indicative of an absence of anxiety at Week 52 (in participants with BL HADS subscale scores indicative of anxiety)
- Part Ia: Response based on T-VASI50 at all time points in the SoA except for those included as primary and key secondary endpointa
- Part Ib: Response based on T-VASI75 (relative to BL) at all time points in the SoA
- Part Ib: Response based on F-VASI75 (relative to BL) at all time points in the SoA
- Part Ib: Response based on T-VASI50 (relative to BL) at all time points in the SoA
- Part Ib: Response based on stabilization of disease at all time points after Week 60
- Part II: Response based on PGIC-F (defined as at least “moderately better” reported change in facial vitiligo from BL) at Weeks 36 and 52
- Part II: Response based on PGIC-V (defined as at least “moderately better” reported change in total body vitiligo from BL) at Weeks 36 and 52
- Part II: Response based on improvement in PGIS-Fb at Weeks 36 and 52
- Part II: Response based on improvement in PGIS-Vc at Weeks 36 and 52
- Part II: CFB in DLQI at Week 52
- Part II: CFB in the HADS depression subscale at Week 52
- Part II: Response based on a ‘normal’ subscale score indicative of an absence of depression at Week 52 (in participants with BL HADS subscale scores indicative of depression)
- Part II: Response based on a ‘normal’ subscale score indicative of an absence of anxiety at Week 52 (in participants with BL HADS subscale scores indicative of anxiety)
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (76)
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