A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Launched by ABBVIE · May 26, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called upadacitinib to see how effective and safe it is for treating moderate to severe hidradenitis suppurativa (HS) in adults and adolescents who have not had success with other treatments. HS is a painful skin condition that causes bumps and abscesses, usually in areas like the armpits, groin, and around the genitals. The trial involves about 1,328 participants across 275 locations worldwide, who will take either upadacitinib or a placebo (a non-active pill) for 36 weeks, followed by an additional 68 weeks for eligible participants. The aim is to check how well the treatment reduces HS symptoms and to monitor any side effects that may occur.
To be eligible for this study, participants must have been diagnosed with HS for at least six months and have previously tried at least one anti-TNF therapy without success or experienced side effects. They should also have a certain number of HS lesions present and meet other specific criteria. Throughout the trial, participants will attend regular check-ups to assess their health and answer questionnaires about their experience. It’s important to note that while this trial may require more visits and monitoring than standard care, it aims to find better treatment options for those suffering from HS.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of hidradenitis suppurativa (HS) for at least 6 months prior to Baseline, as determined by the investigator (i.e., through medical history and interview of participant).
- • Documented history of previous use of \>= 1 tumor necrosis factor (TNF) inhibitor for HS for at least 12 weeks and/or 1 approved non-anti-TNF biologic therapy for HS for at least 16 weeks characterized by inadequate response or for any duration characterized by intolerance as determined by the investigator.
- • Participant must have a total abscess and inflammatory nodule (AN) count of \>= 5 at Baseline.
- • HS lesions must be present in at least 2 distinct anatomic areas at Baseline.
- • At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
- • Draining fistula count of \<= 20 at Baseline.
- Exclusion Criteria:
- • History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.
- • Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or be currently enrolled in another interventional clinical study. Investigational drugs are also prohibited during the study.
- • Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g., rituximab) within 12 months prior to Baseline or until B cell count returns to normal level or pre-treatment level.
- • Use of prescription topical therapies (including topical antibiotics) that can also be used to treat HS within 14 days prior to the Baseline visit.
- • Received any systemic (including oral) antibiotic treatment for HS or any other chronic inflammatory disorder within 14 days prior to the Baseline visit.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Phoenix, Arizona, United States
Fayetteville, Arkansas, United States
Hot Springs, Arkansas, United States
North Little Rock, Arkansas, United States
Encino, California, United States
Boca Raton, Florida, United States
Hollywood, Florida, United States
Tampa, Florida, United States
Indianapolis, Indiana, United States
Saint Joseph, Missouri, United States
Oklahoma City, Oklahoma, United States
Arlington, Texas, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Webster, Texas, United States
Thousand Oaks, California, United States
Waterford, Michigan, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Las Vegas, Nevada, United States
Rogers, Arkansas, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Columbus, Ohio, United States
Tampa, Florida, United States
Boise, Idaho, United States
Los Angeles, California, United States
Sacramento, California, United States
Charlotte, North Carolina, United States
Lynchburg, Virginia, United States
Brandon, Florida, United States
Reno, Nevada, United States
Mason, Ohio, United States
Plano, Texas, United States
Birmingham, Alabama, United States
Coral Gables, Florida, United States
Dallas, Texas, United States
Kyoto Shi, Kyoto, Japan
Osakasayama Shi, Osaka, Japan
Nakagami Gun, Okinawa, Japan
Fukuoka Shi, Fukuoka, Japan
Webster, Texas, United States
Nishinomiya Shi, Hyogo, Japan
Columbus, Georgia, United States
Skokie, Illinois, United States
Spokane, Washington, United States
Minato Ku, Tokyo, Japan
San Diego, California, United States
Leawood, Kansas, United States
Lee's Summit, Missouri, United States
Saint Louis, Missouri, United States
Verona, New Jersey, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charlottesville, Virginia, United States
Phillip, Australian Capital Territory, Australia
Darlinghurst, New South Wales, Australia
Carlton, Victoria, Australia
East Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Surrey, British Columbia, Canada
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Markham, Ontario, Canada
Newmarket, Ontario, Canada
Richmond Hill, Ontario, Canada
Toronto, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Sendai Shi, Miyagi, Japan
Otsu Shi, Shiga, Japan
Itabashi Ku, Tokyo, Japan
Seongnam Si, Gyeonggido, Korea, Republic Of
Seoul, , Korea, Republic Of
Epsom, Auckland, New Zealand
Hamilton, , New Zealand
Caguas, , Puerto Rico
Granada, , Spain
Taipei City, , Taiwan
Linz, Oberoesterreich, Austria
Brescia, , Italy
Madrid, , Spain
Yongsan Gu, , Korea, Republic Of
Budapest, Pest, Hungary
Debrecen, , Hungary
Ansan, Gyeonggido, Korea, Republic Of
Seoul, , Korea, Republic Of
Quincy, Massachusetts, United States
Grapevine, Texas, United States
Sofia, , Bulgaria
Ramat Gan, Tel Aviv, Israel
Changhua City, Changhua County, , Taiwan
Zagreb, Grad Zagreb, Croatia
Rijeka, , Croatia
Sofia, , Bulgaria
Saint Jerome, Quebec, Canada
Margate, Florida, United States
Sofia, , Bulgaria
Grad Zagreb, , Croatia
Valencia, , Spain
Graz, Steiermark, Austria
Stara Zagora, , Bulgaria
Pecs, , Hungary
Debrecen, Hajdu Bihar, Hungary
Boston, Massachusetts, United States
Zagreb, Grad Zagreb, Croatia
Tsukuba Shi, Ibaraki, Japan
Markham, Ontario, Canada
Haifa, H Efa, Israel
Groningen, , Netherlands
Majadahonda, Madrid, Spain
Tampa, Florida, United States
Ivanic Grad, Zagrebacka Zupanija, Croatia
Rome, Roma, Italy
Manises, Valencia, Spain
Norfolk, Virginia, United States
Carolina, , Puerto Rico
Sacramento, California, United States
Québec, Quebec, Canada
Budapest, , Hungary
Tel Aviv, Tel Aviv, Israel
Barcelona, , Spain
Vienna, Wien, Austria
Kaposvár, Somogy, Hungary
Safed, Hatsafon, Israel
Florence, , Italy
Barcelona, , Spain
Taoyuan City, , Taiwan
Farmington, Connecticut, United States
Kaohsiung City, Kaohsiung, Taiwan
Murray, Utah, United States
Mill Creek, Washington, United States
Melbourne, Victoria, Australia
Zagreb, Grad Zagreb, Croatia
Bern, , Switzerland
St. Gallen, Sankt Gallen, Switzerland
Hamilton, , New Zealand
St. John's, Newfoundland And Labrador, Canada
Tampa, Florida, United States
Knoxville, Tennessee, United States
Bochum, , Germany
Bramsche, , Germany
Mainz, , Germany
Regensburg, , Germany
Budapest, , Hungary
Haifa, H Efa, Israel
Milan, , Italy
Roma, , Italy
Breda, , Netherlands
Lisboa, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Porto, , Portugal
Martin, , Slovakia
Nantes, Pays De La Loire, France
Reims, Marne, France
Southampton, Hampshire, United Kingdom
West Lafayette, Indiana, United States
Lee's Summit, Missouri, United States
Split, Splitsko Dalmatinska Zupanija, Croatia
Lyon, Rhone, France
Cona, Ferrara, Italy
Bern, , Switzerland
West Lafayette, Indiana, United States
Knoxville, Tennessee, United States
Budapest, , Hungary
Leeds, , United Kingdom
Praha, , Czechia
Praha, , Czechia
Nice, Alpes Maritimes, France
Edmonton, Alberta, Canada
Magdeburg, , Germany
Munich, , Germany
Antony, Ile De France, France
L'hospitalet De Llobregat, Barcelona, Spain
Chicago, Illinois, United States
Calgary, Alberta, Canada
Berlin, , Germany
Szeged, Csongrad, Hungary
Singapore, Central Singapore, Singapore
London, , United Kingdom
Zurich, Zuerich, Switzerland
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
North Little Rock, Arkansas, United States
Encino, California, United States
New Haven, Connecticut, United States
Boca Raton, Florida, United States
Coral Gables, Florida, United States
Margate, Florida, United States
Waterford, Michigan, United States
Lee's Summit, Missouri, United States
Saint Louis, Missouri, United States
Reno, Nevada, United States
New Hyde Park, New York, United States
Oklahoma City, Oklahoma, United States
Webster, Texas, United States
Murray, Utah, United States
Mill Creek, Washington, United States
East Melbourne, Victoria, Australia
Anderlecht, Bruxelles Capitale, Belgium
Charleroi, Hainaut, Belgium
Gent, Oost Vlaanderen, Belgium
Leuven, Vlaams Brabant, Belgium
Porto Alegre, Rio Grande Do Sul, Brazil
Ribeirão Preto, Sao Paulo, Brazil
São Paulo, Sao Paulo, Brazil
Sao Paulo, , Brazil
Sofiya, , Bulgaria
Calgary, Alberta, Canada
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Surrey, British Columbia, Canada
Markham, Ontario, Canada
Newmarket, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Independencia, Region Metropolitana De Santiago, Chile
Las Condes, , Chile
Santiago, , Chile
Santiago, , Chile
Split, Splitsko Dalmatinska Zupanija, Croatia
Karlovy Vary, , Czechia
Prague, , Czechia
Oulu, , Finland
Tampere, , Finland
Nice, Alpes Maritimes, France
Bordeaux, Gironde, France
Athens, Attiki, Greece
Athens, Attiki, Greece
Athens, Attiki, Greece
Thessaloniki, , Greece
Debrecen, Hajdu Bihar, Hungary
Debrecen, , Hungary
Szeged, , Hungary
Dublin 8, Dublin, Ireland
Cork, , Ireland
Dublin, , Ireland
Galway, , Ireland
Waterford, , Ireland
Haifa, , Israel
Pisa, , Italy
Seongnam, Gyeonggido, Korea, Republic Of
Seoul, , Korea, Republic Of
Vilnius, , Lithuania
Vilnius, , Lithuania
Breda, Noord Brabant, Netherlands
Lisbon, , Portugal
Riyadh, Ar Riyad, Saudi Arabia
Riyadh, Ar Riyad, Saudi Arabia
Jeddah, Makkah, Saudi Arabia
Riyadh, , Saudi Arabia
Singapore, , Singapore
Martin, Zilinsky Kraj, Slovakia
Bratislava, , Slovakia
Trnava, , Slovakia
L'hospitalet De Llobregat, Barcelona, Spain
Majadahonda, Madrid, Spain
Solna, , Sweden
Zürich, , Switzerland
Bursa, , Turkey
Samsun, , Turkey
Salford, , United Kingdom
Tooting, , United Kingdom
Encino, California, United States
Sacramento, California, United States
Skokie, Illinois, United States
Worcester, Massachusetts, United States
Hershey, Pennsylvania, United States
São Paulo, Sao Paulo, Brazil
Bramsche, Niedersachsen, Germany
Ansan Si, Gyeonggido, Korea, Republic Of
Bratislava, Bratislavsky Kraj, Slovakia
Szombathely, Vas, Hungary
Margate, Florida, United States
Thessaloniki, , Greece
Solna, Stockholms Lan, Sweden
Zurich, Zuerich, Switzerland
Melbourne, Victoria, Australia
Solna, Stockholms Lan, Sweden
Taipei City, Taipei, Taiwan
Samsun, , Turkey
Boston, Massachusetts, United States
Kayseri, , Turkey
Liège, Liege, Belgium
Vitacura, Region Metropolitana Santiago, Chile
Modena, , Italy
Nove Zamky, , Slovakia
Durham, North Carolina, United States
Coventry, , United Kingdom
Scottsdale, Arizona, United States
Saint Louis, Missouri, United States
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Buenos Aires, , Argentina
Jette, Bruxelles Capitale, Belgium
Woluwe Saint Lambert, Bruxelles Capitale, Belgium
Macaé, Rio De Janeiro, Brazil
Montreal, Quebec, Canada
Las Condes, Region Metropolitana Santiago, Chile
Medellin, Antioquia, Colombia
Oulu, Etela Pohjanmaa, Finland
Tampere, Etela Pohjanmaa, Finland
Thessaloniki, Evrytania, Greece
Thessaloniki, Evrytania, Greece
Pecs, Nograd, Hungary
Cona, Ferrara, Italy
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Vilnius, Kazlu Rudos, Lithuania
Vilnius, Kazlu Rudos, Lithuania
Hamilton, Manawatu Wanganui, New Zealand
Lisboa, Regiao Autonoma Da Madeira, Portugal
Porto, Regiao Autonoma Da Madeira, Portugal
Nove Zamky, Bratislavsky Kraj, Slovakia
Košice, Kosicky Kraj, Slovakia
Coventry, Bolton, United Kingdom
Ankara, Adana, Turkey
New York, New York, United States
Zagreb, Grad Zagreb, Croatia
Göteborg, Vastra Gotalands Lan, Sweden
Portland, Oregon, United States
Caba, , Argentina
Cona, Ferrara, Italy
Rome, Roma, Italy
Brescia, , Italy
Milano, , Italy
Leeds, West Yorkshire, United Kingdom
Santiago, Region Metropolitana Santiago, Chile
Roma, , Italy
Tampere, Pirkanmaa, Finland
Oulu, Pohjois Pohjanmaa, Finland
Pecs, Baranya, Hungary
Hamilton, Waikato, New Zealand
Nove Zamky, Nitriansky Kraj, Slovakia
Ankara, , Turkey
Coventry, Warwickshire, United Kingdom
Istanbul, , Turkey
Barranquilla, Atlantico, Colombia
Florence, Firenze, Italy
Rome, Roma, Italy
London, Greater London, United Kingdom
Bogotá, Cundinamarca, Colombia
Rome, Roma, Italy
Rome, Roma, Italy
Norfolk, Virginia, United States
Darlinghurst, New South Wales, Australia
Zagreb, Grad Zagreb, Croatia
Tampa, Florida, United States
Budapest, , Hungary
Charleroi, Hainaut, Belgium
Otsu, Shiga, Japan
Petah Tikva, , Israel
Florence, Firenze, Italy
Las Vegas, Nevada, United States
Merzig, Saarland, Germany
Québec, Quebec, Canada
Nice, Alpes Maritimes, France
Vilnius, , Lithuania
Vilnius, , Lithuania
Mainz, Rheinland Pfalz, Germany
Bayraklı, , Turkey
Medellín, Antioquia, Colombia
Bristol, , United Kingdom
Bowling Green, Kentucky, United States
Erlangen, Bayern, Germany
Bruxelles, Bruxelles Capitale, Belgium
Encino, California, United States
Charleston, South Carolina, United States
Pilar, Buenos Aires, Argentina
Charleroi, Hainaut, Belgium
Quebec, , Canada
Monterrey, Nuevo Leon, Mexico
Mexico City, , Mexico
Kirksville, Missouri, United States
Canton, Michigan, United States
Newmarket, Ontario, Canada
Haifa, , Israel
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported