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.

Phase 2Active Not RecruitingNCT07228390

Pfizer128 enrolled

Overview

The purpose of this study is to learn about the safety and effects of the study medicine (called Ritlecitinib) for the possible treatment of hidradenitis suppurativa (HS). HS is a disease causing long lasting painful red skin lumps. This study is seeking participants who: * have moderate or severe HS * have previously received antibiotics for HS that did not help, or could not tolerate antibiotics Participants will be randomly (like a flip of coin) assigned to receive either the study medicine or a placebo (a pill that looks like the study medicine but does not contain any medicine). The study medicine or placebo will be taken by mouth once daily at home. For the first part of the study, participants will receive a loading (starting) dose. For the next part of the study, participants will receive a maintenance (ongoing) dose. Participants will take part in the study for about 24 weeks (about 6 months). There will be about 10 study clinic visits: a screening visit, Day 1, and then every 1, 2, or 4 weeks until week 16. At each visit, participants will report on their health and have tests such as physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will record when they take the study medicine and their HS symptoms every day in an eDiary on a mobile phone. The experiences of participants receiving the study medicine will be compared to those receiving placebo to help see if the study medicine is safe and effective.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

128

Conditions

Hidradenitis Suppurativa

Interventions

RitlecitinibDRUG

Participants will receive one oral dose once daily (QD), starting with a loading dose of ritlecitinib for 8 weeks, followed by maintenance for 8 weeks.

PlaceboDRUG

Participant will receive matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Key Eligibility Criteria: Inclusion Criteria: 1. Male or female participants ≥18 to ≤75 years of age. 2. Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS. Exclusion Criteria: 1. Presence of ≥20 draining fistulae at Screening or BL visit 2. Evidence of other active skin disease or condition at screening 3. Have a known immunodeficiency disorder 4. Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB 5. Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection 6. Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions 7. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years

Locations (67)

Medical Dermatology Specialists

Phoenix, Arizona, United States

Mayo Clinic Hospital

Phoenix, Arizona, United States

Mayo Clinic Specialty Building

Phoenix, Arizona, United States

Mayo Clinic

Scottsdale, Arizona, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Outcomes

Primary Outcomes

Difference in proportion of responders based on Hidradenitis Suppurativa Clinical Response achieving at least 50% reduction from baseline (Hidradenitis Suppurativa Clinical Response HiSCR50) in patients with HS treated with ritlecitinib versus placebo.

The difference in proportion of responders based on HiSCR50 response at Week 16 in patients with HS treated with ritlecitinib versus placebo.

Time frame: Week 16

Secondary Outcomes

Proportion of participants achieving HiSCR50 response

The difference in proportion of responders based on HiSCR50 response at Weeks 1, 2, 4, 6, 8 and 12 in patients with HS treated with ritlecitinib versus placebo

Time frame: at Weeks 1, 2, 4, 6, 8 and Week 12.

Proportion of participants achieving HiSCR75 response

The difference in proportion of responders based on HISCR75 response at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib versus placebo

Time frame: at Weeks 1, 2, 4, 6, 8, 12 and Week 16.

Proportion of participants achieving HiSCR90 response

The difference in proportion of responders based on HiSCR90 response at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib versus placebo

Time frame: at Weeks 1, 2, 4, 6, 8, 12 and Week 16

Response based on a on total abscess and inflammatory nodule count (AN Count) of 0 or 1

The difference in proportion of responders based on a total AN count of 0 or 1 at Week 16 in patients with HS treated with ritlecitinib and placebo

Time frame: Week 16

Response based on a total AN count of 0, 1, or 2

The difference in proportion of responders based on a total AN count of 0, 1 or 2 at Week 16 in patients with HS treated with ritlecitinib and placebo.

Time frame: At week 16

Percent change from Baseline(CFB) in total AN count

The difference in mean percent CFB in total AN count at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

Time frame: Weeks 1, 2, 4, 6, 8, 12 and 16.

Absolute score in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)

The difference in mean absolute score in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

Time frame: at Weeks 1, 2, 4, 6, 8, 12 and 16

CFB in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)

Mean CFB in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

Time frame: at Weeks 1, 2, 4, 6, 8, 12 and 16

Proportion of participants achieving a HS-IGA=0 or 1

The difference in proportion of responders based on HS-IGA=0 or 1 at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

Time frame: Weeks 1, 2, 4, 6, 8, 12 and 16

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

The difference in proportion of HS flare at Weeks 4, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo

Time frame: Weeks 4, 8, 12 and 16.

CFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD)

Time frame: Weeks 1, 2, 4, 6, 8, 12 and 16

Skin pain NRS30 (numeric rating scale) response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3

Time frame: Weeks 1, 2, 4, 6, 8, 12, and 16

Percent CFB in skin pain NRS, at worst and on average, respectively, in participants with baseline skin pain NRS ≥3

Time frame: Weeks 1, 2, 4, 6, 8, 12, and 16

CFB in skin pain NRS, at worst and on average, respectively

Time frame: at Weeks 1, 2, 4, 6, 8, 12, and 16

Skin pain NRS50 response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3.

Time frame: at Weeks 1, 2, 4, 6, 8, 12, and 16

Skin pain NRS70 response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3

Time frame: at Weeks 1, 2, 4, 6, 8, 12, and 16,

Incidence of treatment emergent adverse events (TEAE), adverse events (AE) and serious adverse events (SAE) leading to discontinuation

Time frame: up to 24 Weeks

Incidence of clinically significant laboratory abnormalities over time

Time frame: up to 24 Weeks

Absolute score and CFB in Hidradenitis Suppurativa Quality of Life (HiSQOL)

Time frame: at Weeks 1, 2, 4, 6, 8, 12 and 16.

Absolute score and % CFB in International Hidradenitis Suppurativa Severity Score System (IHS4)

Time frame: Weeks 1, 2, 4, 6, 8, 12 and 16.

Data from ClinicalTrials.gov

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