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Ritlecitinib 50 mg for Vitiligo

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
VitiligoRitlecitinib - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

A 52-Week Study of Ritlecitinib Oral Capsules in Adults and Adolescents with Vitiligo (Active and Stable)

Eligible Conditions
  • Vitiligo

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Bictegravir
1
R3R01
1
Plasmapheresis

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 36 and 52 weeks

24 weeks
Proportion of participants achieving F-VASI75 at Week 24.
36 and 52 weeks
CDLQI/DLQI
Anxiety
Face
Patient Global Impression of Change-Overall Vitiligo
Face
Patient Global Impression of Severity-Overall Vitiligo
36 weeks
Proportion of participants achieving F-VASI75 at Week 36.
52 Weeks
Stabilization of disease
52 weeks
F-VASI75 and T-VASI50 comprise the primary endpoint family at 52 weeks
For the EU: Proportion of participants achieving F-VASI75 at Week 52.
For the EU: Proportion of participants achieving T-VASI50 at Week 52
Incidence of TEAEs, SAEs, and AEs leading to discontinuation. Incidence of clinically significant laboratory abnormalities

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Bictegravir
2
R3R01
1
Plasmapheresis

Trial Design

2 Treatment Groups

Ritlecitinib 50 mg
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

600 Total Participants · 2 Treatment Groups

Primary Treatment: Ritlecitinib 50 mg · Has Placebo Group · Phase 3

Ritlecitinib 50 mg
Drug
Experimental Group · 1 Intervention: Ritlecitinib · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritlecitinib
2020
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 and 52 weeks

Who is running the clinical trial?

PfizerLead Sponsor
4,303 Previous Clinical Trials
7,143,678 Total Patients Enrolled
5 Trials studying Vitiligo
142,385 Patients Enrolled for Vitiligo
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,277 Previous Clinical Trials
4,853,584 Total Patients Enrolled
1 Trials studying Vitiligo
366 Patients Enrolled for Vitiligo

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of depigmentation at sites of trauma.
You have vitiligo in a non-segmental distribution.
References

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