B7981041: A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Conditions

NON SEGMENTAL VITILIGO

Brief summary

Incidence of TEAEs, SAEs, and AEs leading to discontinuation, Incidence of clinically significant laboratory abnormalities.

Detailed description

Response based on T-VASI75 (defined as at least 75% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA, Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA, Response based on T-VASI50 (defined as at least 50% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA, Percent Change from Study B7981040 BL in F-VASI at all time points in the SoA, Percent Change from Study B7981040 BL in T-VASI at all time points in the SoA, Response based on stabilization of disease at all time points after Week 8, defined as: <15-point increase in T-VASI from Study B7981040 Baseline (based on twice the magnitude of the smallest detectable change of 7.1 points in T-VASI) [38]; AND meeting all other criteria for stability, Response based on F-VASI50 (defined as at least 50% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA, Response based on F-VASI90 (defined as at least 90% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA, Response based on F-VASI100 (defined as 100% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA, Response based on T-VASI90 (defined as at least 90% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA, Response based on T-VASI100 (defined as 100% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA, Response based on improvement in Patient Global Impression of Severity – Face (PGISF) at all time points in SoA, Response based on improvement in PGIS-V at all time points in the SoA, Response based on scoring at least “moderately better” on PGIC-F at all time points in the SoA, Response based on scoring at least “moderately better” on PGIC-V at all time points in the SoA

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGCapsule to match PF-06651600 (Ritlecitinib) 50 mg

DRUGCapsule to match pf-06651600 (ritlecitinib) 100 mg

DRUGRitlecitinib Tosilate

DRUGDEXAMETHASONE

DRUGRitlecitinib tosilate

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of TEAEs, SAEs, and AEs leading to discontinuation, Incidence of clinically significant laboratory abnormalities.	—

Secondary

Measure	Time frame
Response based on T-VASI75 (defined as at least 75% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA, Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA, Response based on T-VASI50 (defined as at least 50% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA, Percent Change from Study B7981040 BL in F-VASI at all time points in the SoA, Percent Change from Study B7981040 BL in T-VASI at all time points in the SoA, Response based on stabilization of disease at all time points after Week 8, defined as: <15-point increase in T-VASI from Study B7981040 Baseline (based on twice the magnitude of the smallest detectable change of 7.1 points in T-VASI) [38]; AND meeting all other criteria for stability, Response based on F-VASI50 (defined as at least 50% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA, Response based on F-VASI90 (defined as	—

Measure

Time frame

Response based on T-VASI75 (defined as at least 75% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA, Response based on F-VASI75 (defined as at least 75% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA, Response based on T-VASI50 (defined as at least 50% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA, Percent Change from Study B7981040 BL in F-VASI at all time points in the SoA, Percent Change from Study B7981040 BL in T-VASI at all time points in the SoA, Response based on stabilization of disease at all time points after Week 8, defined as: <15-point increase in T-VASI from Study B7981040 Baseline (based on twice the magnitude of the smallest detectable change of 7.1 points in T-VASI) [38]; AND meeting all other criteria for stability, Response based on F-VASI50 (defined as at least 50% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA, Response based on F-VASI90 (defined as

—

Countries

Bulgaria, Germany, Italy, Poland, Spain

Outcome results

None listed