A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

21 Apr 2026 → ongoing

Decision date (initial)

2026-03-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001, USA

External identifiers

EU CT number

2025-522705-37-00

ClinicalTrials.gov

NCT07228390

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To evaluate the efficacy of ritlecitinib versus placebo in participants with HS as assessed by Hidradenitis Suppurativa Clinical Response (HiSCR)50.

Secondary objectives 7

1. To evaluate the efficacy of ritlecitinib versus placebo in participants with HS as assessed by HiSCR50, HiSCR75, HiSCR90, and total AN count outcomes.
2. To evaluate the effects of ritlecitinib versus placebo in participants with HS on HS flare.
3. To evaluate the efficacy of ritlecitinib versus placebo in participants with HS on pain and reduction of HS symptoms.
4. To assess the safety and tolerability of ritlecitinib versus placebo in participants with HS.
5. To evaluate the effects of ritlecitinib versus placebo in participants with HS on HS related quality of life.
6. To evaluate the effects of ritlecitinib versus placebo in participants with HS on International Hidradenitis Suppurativa Severity Score System (IHS4).
7. To evaluate the efficacy of ritlecitinib versus placebo in participants with HS on Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA).

Conditions and MedDRA coding

HIDRADENITIS SUPPURATIVA

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Eligible participants must be aged ≥18 years old to ≤75 years of age with a documented clinical diagnosis of HS for at least 6 months.
2. Participants must have moderate to severe disease at baseline, defined as Hurley Stage II or III with ≥5 inflammatory lesions (abscesses and/or nodules not including draining fistulas) across at least 2 distinct anatomical areas.
3. Participants must have had an inadequate response to at least a 4-week course of systemic therapy for HS, or a documented medical reason as to why systemic treatment is not appropriate.

Exclusion criteria 5

1. ≥20 draining fistula count
2. confounding dermatologic conditions
3. prior use of a JAK inhibitor or BTK inhibitor
4. any significant medical or psychiatric illness
5. a maximum of approximately 40% of enrolled participants may have received prior anti-TNF-α treatment, IL-17 inhibitor, or IL-23 inhibitor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. HiSCR50 response at Week 16

Secondary endpoints 19

1. HiSCR50 response at Weeks 1, 2, 4, 6, 8, and Week 12.
2. HiSCR75 response at Weeks 1, 2, 4, 6, 8, 12 and Week 16.
3. HiSCR90 response at Weeks 1, 2, 4, 6, 8, 12 and Week 16.
4. Response based on a total abscess and nodule (AN) count of 0 or 1 at Week 16.
5. Response based on a total AN count of 0, 1, or 2 at Week 16.
6. Percent (%) change from baseline (CFB) in total AN count at Weeks 1, 2, 4, 6, 8, 12 and 16.
7. Absolute score and CFB in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16.
8. Response based on achieving a HS-IGA=0 or 1 at Weeks 1, 2, 4, 6, 8, 12 and 16.
9. Participants who experience an HS flare, defined as at least a 25% increase in total AN count with a minimum increase of 2 relative to Baseline, at Weeks 4, 8, 12 and 16.
10. CFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) at Weeks 1, 2, 4, 6, 8, 12 and 16.
11. Skin pain NRS30 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain numeric rating scale (NRS) ≥3.
12. %CFB in skin pain NRS, at worst and on average, respectively, in participants with baseline skin pain NRS ≥3, at Weeks 1, 2, 4, 6, 8, 12, and 16.
13. CFB in skin pain NRS, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16.
14. Skin pain NRS50 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain NRS ≥3.
15. Skin pain NRS70 response, at worst and on average, respectively, at Weeks 1, 2, 4, 6, 8, 12, and 16, among participants with baseline skin pain NRS ≥3.
16. Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation
17. Incidence of clinically significant laboratory abnormalities over time
18. Absolute score and CFB in Hidradenitis Suppurativa Quality of Life (HiSQOL) at Weeks 1, 2, 4, 6, 8, 12 and 16.
19. Absolute score and % CFB in IHS4 at Weeks 1, 2, 4, 6, 8, 12 and 16.

Investigational products

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

Test 1

Placebo 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 5

Locations

4 EU/EEA countries · 29 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 26 files

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

Application history

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