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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522705-37-00 | Registry Identifier | CTIS (EU) |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Intervention | Experimental | 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 | Placebo Comparator | Participants will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritlecitinib | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at Weeks 1, 2, 4, 6, 8 and Week 12. |
| Proportion of participants achieving HiSCR75 response |
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Key Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Specialists | Recruiting | Phoenix | Arizona | 85006 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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|
| Placebo | Drug | Participant will receive matching placebo |
|
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 |
| 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | Weeks 4, 8, 12 and 16. |
| 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. |
| Mayo Clinic Hospital |
| Not yet recruiting |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Mayo Clinic Specialty Building | Not yet recruiting | Phoenix | Arizona | 85054 | United States |
| Mayo Clinic | Not yet recruiting | Scottsdale | Arizona | 85259 | United States |
| Burke Pharmaceutical Research | Recruiting | Hot Springs | Arkansas | 71913 | United States |
| First OC Dermatology Research Inc | Recruiting | Fountain Valley | California | 92708 | United States |
| Carbon Health - Urgent Care - La Habra | Recruiting | La Habra | California | 90631 | United States |
| Northridge Clinical Trials | Recruiting | Northridge | California | 91325 | United States |
| Integrative Skin Science and Research | Recruiting | Sacramento | California | 95815 | United States |
| Wolverine Clinical Trials | Recruiting | Santa Ana | California | 92706 | United States |
| Skin Care Research | Recruiting | Boca Raton | Florida | 33486 | United States |
| Olympian Clinical Research | Recruiting | Largo | Florida | 33770 | United States |
| Ziaderm Research LLC | Recruiting | North Miami Beach | Florida | 33162 | United States |
| D&H Tamarac Research Center | Recruiting | Tamarac | Florida | 33321 | United States |
| NMC Research LLC | Recruiting | Tampa | Florida | 33607 | United States |
| USF - Carol and Frank Morsani Center for Advanced Healthcare-Clinical Research Center | Recruiting | Tampa | Florida | 33612 | United States |
| Alliance Clinical Research of Tampa | Recruiting | Tampa | Florida | 33615 | United States |
| Olympian Clinical Research | Recruiting | Tampa | Florida | 33615 | United States |
| USF Florida Hearing Clinic | Recruiting | Tampa | Florida | 33620 | United States |
| TruDerm & TruSpa | Recruiting | Wellington | Florida | 33449 | United States |
| Advanced Medical Research, PC. | Recruiting | Sandy Springs | Georgia | 30328 | United States |
| Endeavor Health | Recruiting | Skokie | Illinois | 60077 | United States |
| Whisper Hearing Center | Recruiting | Indianapolis | Indiana | 46240 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Recruiting | Indianapolis | Indiana | 46250 | United States |
| Community Imaging Center | Recruiting | Indianapolis | Indiana | 46256 | United States |
| The Indiana Clinical Trials Center, PC | Recruiting | Plainfield | Indiana | 46168 | United States |
| Options Research Group | Recruiting | West Lafayette | Indiana | 47906 | United States |
| Essential Medical Research - Overland Park | Recruiting | Overland Park | Kansas | 66213 | United States |
| Skin and Hair Center | Recruiting | Overland Park | Kansas | 66213 | United States |
| DS Research of Kentucky | Recruiting | Louisville | Kentucky | 40241 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Revival Research Institute, LLC | Recruiting | Southfield | Michigan | 48034 | United States |
| Skin Specialists, PC dba Schlessinger MD | Recruiting | Omaha | Nebraska | 68144 | United States |
| Stracskin | Recruiting | Portsmouth | New Hampshire | 03801 | United States |
| DJL Clinical Research, PLLC | Recruiting | Charlotte | North Carolina | 28211 | United States |
| ClinOhio Research Services | Recruiting | Columbus | Ohio | 43213 | United States |
| Columbia Dermatology & Aesthetics | Recruiting | Columbia | South Carolina | 29212 | United States |
| Palmetto Clinical Trial Services - Greenville | Recruiting | Greenville | South Carolina | 29615 | United States |
| Center for Clinical Studies, LTD. LLP | Recruiting | Houston | Texas | 77004 | United States |
| Eurofins CRL | Recruiting | Forest | Virginia | 24551 | United States |
| Dermatology Research Institute | Recruiting | Calgary | Alberta | T2J 7E1 | Canada |
| Laser Rejuvenation Clinics Edmonton D.T. Inc | Recruiting | Edmonton | Alberta | T5J 3S9 | Canada |
| Skin Physicians Dermatology | Recruiting | Edmonton | Alberta | T6W 4V4 | Canada |
| CaRe Clinic | Recruiting | Red Deer | Alberta | T4P 1K4 | Canada |
| Ryan Clinical Research Inc. | Recruiting | Newmarket | Ontario | L3Y 5G8 | Canada |
| DAR Clinical Research | Recruiting | Ottawa | Ontario | K1V 1C1 | Canada |
| North York Research Inc | Recruiting | Toronto | Ontario | M2N 3A6 | Canada |
| FACET Dermatology | Recruiting | Toronto | Ontario | M4E 1R7 | Canada |
| Centre de Recherche Saint-Louis inc. | Recruiting | Québec | G1W 4R4 | Canada |
| Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum Frankfurt | Recruiting | Frankfurt | 60590 | Germany |
| Universitätsklinikum Schleswig Holstein - Campus Lübeck | Recruiting | Lübeck | 23538 | Germany |
| Athens Medical Center - Psychikon branch | Recruiting | Athens | Attica | 11525 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Recruiting | Thessaloniki | Thessaloníki | 564 29 | Greece |
| University General Hospital of Larissa | Recruiting | Larissa | Thessalía | 411 10 | Greece |
| Dermatological and Venereological Hospital Andreas Syggros | Recruiting | Athens | 161 21 | Greece |
| Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska | Recruiting | Wroclaw | Lower Silesian Voivodeship | 50-566 | Poland |
| Penta Hospitals Badania Kliniczne sp. z o.o. | Recruiting | Gdansk | 80-546 | Poland |
| Dermedic Jacek Zdybski | Recruiting | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu | Recruiting | Sosnowiec | 41-200 | Poland |
| Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. | Recruiting | Szczecin | 71-500 | Poland |
| Trialmed CRS - Warszawa | Recruiting | Warsaw | 02-482 | Poland |
| Państwowy Instytut Medyczny MSWiA | Recruiting | Warsaw | 02-507 | Poland |
| Klinika Ambroziak Dermatologia | Recruiting | Warsaw | 02-953 | Poland |
| Royalderm Agnieszka Nawrocka | Recruiting | Warsaw | 02-962 | Poland |
| Soft Skin Medical Center Dr Elzbieta Wojtowicz-Prus | Recruiting | Wroclaw | 50-551 | Poland |
| Hospital de Manises | Recruiting | Manises | Valencia | 46940 | Spain |
| Hospital Universitario Puerta del Mar | Recruiting | Cadiz | 11009 | Spain |
| Hospital Universitario Virgen Nieves | Recruiting | Granada | 18012 | Spain |
| Hospital General Universitario Gregorio Maranon | Recruiting | Madrid | 28007 | Spain |
| CHOP-Centro De Especialidades De Mollabao | Recruiting | Pontevedra | 36001 | Spain |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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