Hidradenitis Suppurativa
Conditions
Keywords
Ritlecitinib
Brief summary
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.
Interventions
DRUGRitlecitinib
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.
DRUGPlacebo
Participant will receive matching placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Week 16 | The difference in proportion of responders based on HiSCR50 response at Week 16 in patients with HS treated with ritlecitinib versus placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving HiSCR50 response | at Weeks 1, 2, 4, 6, 8 and Week 12. | 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 |
| Proportion of participants achieving HiSCR75 response | at Weeks 1, 2, 4, 6, 8, 12 and Week 16. | 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 |
| Proportion of participants achieving HiSCR90 response | at Weeks 1, 2, 4, 6, 8, 12 and Week 16 | 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 |
| Response based on a on total abscess and inflammatory nodule count (AN Count) of 0 or 1 | Week 16 | 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 |
| Response based on a total AN count of 0, 1, or 2 | At week 16 | 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. |
| Percent change from Baseline(CFB) in total AN count | Weeks 1, 2, 4, 6, 8, 12 and 16. | 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 |
| Absolute score in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA) | at Weeks 1, 2, 4, 6, 8, 12 and 16 | 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 |
| CFB in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA) | at Weeks 1, 2, 4, 6, 8, 12 and 16 | Mean CFB in HS-IGA at Weeks 1, 2, 4, 6, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo |
| Proportion of participants achieving a HS-IGA=0 or 1 | Weeks 1, 2, 4, 6, 8, 12 and 16 | 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 |
| 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 | Weeks 4, 8, 12 and 16. | The difference in proportion of HS flare at Weeks 4, 8, 12 and 16 in patients with HS treated with ritlecitinib and placebo |
| CFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD) | 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 | 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 | Weeks 1, 2, 4, 6, 8, 12, and 16 | — |
| CFB in skin pain NRS, at worst and on average, respectively | 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. | 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 | 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 | up to 24 Weeks | — |
| Incidence of clinically significant laboratory abnormalities over time | up to 24 Weeks | — |
| Absolute score and CFB in Hidradenitis Suppurativa Quality of Life (HiSQOL) | at Weeks 1, 2, 4, 6, 8, 12 and 16. | — |
| Absolute score and % CFB in International Hidradenitis Suppurativa Severity Score System (IHS4) | Weeks 1, 2, 4, 6, 8, 12 and 16. | — |
Countries
Canada, Germany, Greece, Poland, Spain, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed