A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Launched by ABBVIE · Jun 17, 2024
Trial Information
Current as of May 28, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new drug called lutikizumab to see how well it works and how safe it is for treating moderate to severe hidradenitis suppurativa (HS), a painful skin condition that causes lumps and abscesses in areas like the armpits and groin. The trial is open to adults and adolescents who have had HS for at least six months and have a certain number of painful lumps. Participants will be divided into two groups: one will receive lutikizumab, while the other will receive a placebo (a substance with no active drug). This helps researchers compare the effects of the drug against no treatment.
Participants can expect to receive weekly injections of either lutikizumab or placebo for the first 16 weeks of the study, followed by a second phase where those on placebo will start lutikizumab. They will have regular visits to a clinic for check-ups, blood tests, and to report any side effects. It’s important to note that participants may have more appointments and treatments than they would with standard care. This study is currently recruiting participants at around 275 sites worldwide.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant).
- • Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
- • Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.
- • At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
- Exclusion Criteria:
- • Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- • Confirmed positive anti-HIV antibody (HIV Ab) test.
- • Evidence of active tuberculosis or meets tuberculosis exclusionary parameter
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
Birmingham, Alabama, United States
Phoenix, Arizona, United States
Bryant, Arkansas, United States
North Little Rock, Arkansas, United States
Encino, California, United States
Sacramento, California, United States
Margate, Florida, United States
Tampa, Florida, United States
Dawsonville, Georgia, United States
Rolling Meadows, Illinois, United States
Indianapolis, Indiana, United States
Leawood, Kansas, United States
Lee's Summit, Missouri, United States
Portsmouth, New Hampshire, United States
Bexley, Ohio, United States
Mason, Ohio, United States
Bellaire, Texas, United States
Cypress, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Norfolk, Virginia, United States
San Juan, , Puerto Rico
Columbus, Georgia, United States
Brandon, Florida, United States
Charleston, South Carolina, United States
Clarkston, Michigan, United States
Dallas, Texas, United States
Los Angeles, California, United States
Boise, Idaho, United States
Arlington, Texas, United States
Ocala, Florida, United States
Thousand Oaks, California, United States
Spokane, Washington, United States
Boca Raton, Florida, United States
Hollywood, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Saint Joseph, Missouri, United States
Osaka Shi, Fukui, Japan
Fukuoka, , Japan
Kyoto, , Japan
Toyoake, Aichi, Japan
Louisville, Kentucky, United States
Sydney, New South Wales, Australia
Carolina, , Puerto Rico
Plano, Texas, United States
East Melbourne, Victoria, Australia
Tokyo, Fukui, Japan
Obihiro Shi, Hokkaido, Japan
Osakasayama Shi, Osaka, Japan
Taipei City, Taipei, Taiwan
Taoyuan City, , Taiwan
Miami, Florida, United States
Hamilton, Manawatu Wanganui, New Zealand
Kogarah, New South Wales, Australia
Osaka Shi, Osaka, Japan
Tokyo, , Japan
Hamilton, Waikato, New Zealand
Taipei City, , Taiwan
Bowling Green, Kentucky, United States
Charleston, South Carolina, United States
Koshigaya, Saitama, Japan
Las Vegas, Nevada, United States
Phillip, Australian Capital Territory, Australia
Kaohsiung City, Kaohsiung, Taiwan
Auckland, , New Zealand
Pittsburgh, Pennsylvania, United States
Québec, Quebec, Canada
Taipei City, , Taiwan
Kelowna, British Columbia, Canada
Hamilton, Ontario, Canada
Winston Salem, North Carolina, United States
Gahanna, Ohio, United States
Nagoya, Aichi, Japan
Philadelphia, Pennsylvania, United States
New York, New York, United States
Norfolk, Virginia, United States
Darlinghurst, New South Wales, Australia
Mississauga, Ontario, Canada
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Woolloongabba, Queensland, Australia
Naharia, Hatsafon, Israel
Petah Tikva, Hamerkaz, Israel
Jerusalem, , Israel
Nishihara, Okinawa, Japan
Afula, H Efa, Israel
Waterloo, Ontario, Canada
Saskatoon, Saskatchewan, Canada
Richmond Hill, Ontario, Canada
Tel Aviv, Tel Aviv, Israel
örebro, , Sweden
Québec, Quebec, Canada
Kyoto Shi, Kyoto, Japan
London, Ontario, Canada
St. Gallen, Sankt Gallen, Switzerland
Ramat Gan, Tel Aviv, Israel
Buochs, Nidwalden, Switzerland
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Kragujevac, Pomoravski Okrug, Serbia
Novi Sad, , Serbia
Haifa, , Israel
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Taichung, , Taiwan
Ansan Si, Gyeonggido, Korea, Republic Of
Murray, Utah, United States
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Fredericton, New Brunswick, Canada
Seongnam, Gyeonggido, Korea, Republic Of
Cleveland, Ohio, United States
Ginowan Shi, Okinawa, Japan
Zurich, Zuerich, Switzerland
Drogheda, Louth, Ireland
Belgrade, Beograd, Serbia
Chicago, Illinois, United States
St Jérôme, Quebec, Canada
Dublin, , Ireland
Stavanger, Rogaland, Norway
Tromsø, Troms, Norway
Oslo, , Norway
Belgrade, Beograd, Serbia
London, Greater London, United Kingdom
Québec, Quebec, Canada
Chatsworth, Kwazulu Natal, South Africa
Durban, Kwazulu Natal, South Africa
Brandon, Florida, United States
Pretoria, Gauteng, South Africa
Westville, Kwazulu Natal, South Africa
Mayfield Heights, Ohio, United States
Hellerup, Hovedstaden, Denmark
Dublin, , Ireland
Redwood City, California, United States
Edmonton, Alberta, Canada
Ljubljana, , Slovenia
Canton, Michigan, United States
Spartanburg, South Carolina, United States
Kragujevac, Sumadijski Okrug, Serbia
Portsmouth, New Hampshire, United States
Maribor, , Slovenia
Haifa, H Efa, Israel
Lisbon, Lisboa, Portugal
Memmingen, Bayern, Germany
Thessaloniki, , Greece
Guimaraes, Braga, Portugal
Lisboa, , Portugal
Porto, , Portugal
Gent, Oost Vlaanderen, Belgium
Tübingen, Baden Wuerttemberg, Germany
Athens, Attiki, Greece
Kyoto Shi, Kyoto, Japan
Sabadell, Barcelona, Spain
Madrid, , Spain
Sofiya, Sofia, Bulgaria
Pleven, , Bulgaria
Nové Zámky, Nitriansky Kraj, Slovakia
Valencia, , Spain
Lebanon, New Hampshire, United States
Jette, Bruxelles Capitale, Belgium
Leuven, Vlaams Brabant, Belgium
Sofiya, Sofia, Bulgaria
Stara Zagora, , Bulgaria
St. John's, Newfoundland And Labrador, Canada
Rijeka, , Croatia
Ostrava, Ostrava Mesto, Czechia
Lyon, Auvergne Rhone Alpes, France
Erlangen, Bayern, Germany
Darmstadt, Hessen, Germany
Bad Bentheim, Niedersachsen, Germany
Bochum, Nordrhein Westfalen, Germany
Muenster, Nordrhein Westfalen, Germany
Berlin, , Germany
Thessaloniki, , Greece
Rome, Roma, Italy
Bydgoszcz, Kujawsko Pomorskie, Poland
Lodz, Lodzkie, Poland
Lodz, Lodzkie, Poland
Warszawa, Mazowieckie, Poland
Bratislava, , Slovakia
Trnava, , Slovakia
Málaga, Malaga, Spain
Manises, Valencia, Spain
Dunfermline, Fife, United Kingdom
Graz, Steiermark, Austria
Sofiya, Sofia, Bulgaria
Rouen, Seine Maritime, France
Reims, , France
Athens, Attiki, Greece
Budapest, , Hungary
Krakow, Malopolskie, Poland
Bucharest, , Romania
Bucharest, , Romania
Wien, , Austria
Sofiya, , Bulgaria
Paris, , France
Cluj Napoca, Cluj, Romania
Charleroi, Hainaut, Belgium
Florence, Firenze, Italy
Catania, , Italy
Harrogate, North Yorkshire, United Kingdom
Anderlecht, Bruxelles Capitale, Belgium
Freiburg, Baden Wuerttemberg, Germany
Pécs, , Hungary
Milano, , Italy
Singapore, , Singapore
Singapore, , Singapore
Santander, Cantabria, Spain
Rotterdam, Zuid Holland, Netherlands
St Priest En Jarez, Loire, France
Miami, Florida, United States
Cork, , Ireland
Morioka, Iwate, Japan
Calgary, Alberta, Canada
Karlovy Vary, , Czechia
Liège, Liege, Belgium
Aarhus, Midtjylland, Denmark
Remscheid, Nordrhein Westfalen, Germany
Bruxelles, Bruxelles Capitale, Belgium
Mainz, Rheinland Pfalz, Germany
Cheonan Si, Chungcheongnamdo, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Košice, Kosicky Kraj, Slovakia
Solna, Stockholms Lan, Sweden
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Edmonton, Alberta, Canada
Debrecen, Hajdu Bihar, Hungary
Naples, Napoli, Italy
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported