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.
Purpose
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.
Condition
- Hidradenitis Suppurativa
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Study Intervention |
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. |
|
|
Placebo Comparator Placebo |
Participants will receive matching placebo. |
|
Recruiting Locations
Phoenix, Arizona 85006
Hot Springs, Arkansas 71913
Fountain Valley, California 92708
La Habra, California 90631
Northridge, California 91325
Sacramento, California 95815
Santa Ana, California 92706
Boca Raton, Florida 33486
Largo, Florida 33770
North Miami Beach, Florida 33162
Tamarac, Florida 33321
Tampa, Florida 33607
Tampa, Florida 33612
Tampa, Florida 33615
Tampa, Florida 33615
Tampa, Florida 33620
Wellington, Florida 33449
Sandy Springs, Georgia 30328
Skokie, Illinois 60077
Indianapolis, Indiana 46240
Indianapolis, Indiana 46250
Indianapolis, Indiana 46256
Plainfield, Indiana 46168
West Lafayette, Indiana 47906
Overland Park, Kansas 66213
Overland Park, Kansas 66213
Louisville, Kentucky 40241
Boston, Massachusetts 02215
Southfield, Michigan 48034
Omaha, Nebraska 68144
Portsmouth, New Hampshire 03801
Charlotte, North Carolina 28211
Columbus, Ohio 43213
Columbia, South Carolina 29212
Greenville, South Carolina 29615
Houston, Texas 77004
Forest, Virginia 24551
More Details
- Status
- Recruiting
- Sponsor
- Pfizer