A Phase 3 Study With Randomized Withdrawal/Dose Up Investigating the Efficacy, Safety, and Tolerability of Ritlecitinib in Participants With Nonsegmental Vitiligo

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify

Trial duration

10 Jul 2024 → ongoing

Decision date (initial)

2024-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-505804-42-00

ClinicalTrials.gov

NCT06163326

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the long-term safety and tolerability of ritlecitinib 100 mg QD and ritlecitinib 50 mg QD in adult and adolescent participants with nonsegmental vitiligo

Secondary objectives 2

1. To evaluate the efficacy of ritlecitinib 100 mg QD and 50 mg QD over time as measured by clinical outcomes in adult and adolescent participants who were previously treated for 52 weeks with ritlecitinib 50 mg or placebo in Study B7981040
2. To evaluate the efficacy of ritlecitinib 100 mg QD and 50 mg QD over time as measured by PROs in adult and adolescent participants who were previously treated for 52 weeks with ritlecitinib 50 mg QD or placebo in Study B7981040

Conditions and MedDRA coding

NON SEGMENTAL VITILIGO

Study design 1 period

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, Pharmaceuticals And Medical Devices Agency, Medicines And Healthcare Products Regulatory Agency, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants ≥18 years of age at Screening in Study B7981040. Adolescents (12 to <18 years of age at Screening in the parent study) are also eligible for this study if approved by the local IRB/EC and regulatory health authority. Where these approvals have not been granted, only participants ≥18 years of age will be enrolled.
2. Participants who met the eligibility criteria and completed 52 weeks of study intervention for stable or active nonsegmental vitiligo in Study B7981040 can be enrolled (refer to Appendix 15 for definitions of stable and active nonsegmental vitiligo in Study B7981040).
3. Must agree to not use any other treatments for vitiligo from Screening through the final follow-up visit. See Section 6.9 for information regarding rescue treatment.
4. The BL visit/first dose in Study B7981041 must be within 30 days after the week 52 visit in Study B7981040.

Exclusion criteria 4

1. Participant met the parent study (Study B7981040) discontinuation criteria or discontinued the parent study for any safety-related event: Experienced an event requiring discontinuation from Study B7981040 as outlined in the protocol (lab abnormalities, ECG changes, pregnancy, etc) or; Experienced any AEs that in the judgement of the investigator or the sponsor would deem the participant not appropriate for enrollment in the LTE study (any participant with an SAE considered potential event of interest by the adjudication committee should be discussed with the sponsor) or; Experienced any SAEs that are confirmed events of interest by the adjudication/review committee or; Experienced any clinically meaningful decline in hearing from BL in the parent study.
2. Any active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
3. TB Infection History:Countries in which TB incidence has been reported at a rate of >10 cases per 100,000 persons per WHO or local country epidemiology data only.
4. Other Medical Conditions: Other medical conditions which in the opinion of the investigator or Pfizer make the participant inappropriate for entry into this study or unwilling/unable to comply with study procedures and lifestyle requirements; 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; Considered in imminent need for surgery or with elective surgery scheduled to occur during the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

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

Secondary endpoints 15

1. 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
2. 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
3. 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
4. Percent Change from Study B7981040 BL in F-VASI at all time points in the SoA
5. Percent Change from Study B7981040 BL in T-VASI at all time points in the SoA
6. 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
7. 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
8. 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
9. Response based on F-VASI100 (defined as 100% improvement in F-VASI from Study B7981040 BL) at all time points in the SoA
10. 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
11. Response based on T-VASI100 (defined as 100% improvement in T-VASI from Study B7981040 BL) at all time points in the SoA
12. Response based on improvement in Patient Global Impression of Severity – Face (PGISF) at all time points in SoA
13. Response based on improvement in PGIS-V at all time points in the SoA
14. Response based on scoring at least “moderately better” on PGIC-F at all time points in the SoA
15. Response based on scoring at least “moderately better” on PGIC-V at all time points in the SoA

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 1

Locations

5 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 98 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications