A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa
A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS .
Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms.
In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks.
Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks.
Participants in the US that complete Periods 1 & 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90045, United States
Redwood City, California 94063, United States
Ocala, Florida 34470, United States
Chicago, Illinois 60611-2927, United States
Louisville, Kentucky 40241, United States
Worcester, Massachusetts 01655, United States
Clarkston, Michigan 48346, United States
Lee's Summit, Missouri 64064-2301, United States
Lebanon, New Hampshire 03766, United States
Winston-Salem, North Carolina 27104, United States
Columbus, Ohio 43203, United States
Charleston, South Carolina 29407, United States
Spartanburg, South Carolina 29307, United States
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1428, Argentina
Rosario, Santa Fe Province 2000, Argentina
Anderlecht, Brussels Capital 1070, Belgium
Sarajevo, Federation of Bosnia and Herzegovina 71000, Bosnia and Herzegovina
Tuzla, Federation of Bosnia and Herzegovina 75000, Bosnia and Herzegovina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Banja Luka, Republika Srpska 78000, Bosnia and Herzegovina
Sofiya, Sofia 1407, Bulgaria
Sofiya, Sofia 1407, Bulgaria
Sofiya, Sofia 1463, Bulgaria
Sofiya, Sofia 1510, Bulgaria
Santiago, Region Metropolitana Santiago 8420383, Chile
Barranquilla, Atlántico 80002, Colombia
Bogotá, Cundinamarca 110221, Colombia
Grad Zagreb, City of Zagreb 10000, Croatia
St-Priest-en-Jarez, Pays de la Loire Region 42270, France
Martigues, Provence-Alpes-Côte d'Azur Region 13500, France
Rouen, Seine-Maritime 76031, France
Afula, Haifa District 1834111, Israel
Cona, Ferrara 44124, Italy
Rome, Roma 00168, Italy
Obihiro-Shi, Hokkaido 080-0013, Japan
Shiwa-gun, Iwate 028-3695, Japan
Kyoto, Kyoto 602-8566, Japan
Ginowan-shi, Okinawa 901-2725, Japan
Sakai-shi, Osaka 590-0197, Japan
Kaunas, 50161, Lithuania
Krakow, Lesser Poland Voivodeship 30-002, Poland
Krakow, Lesser Poland Voivodeship 31-011, Poland
Warsaw, Masovian Voivodeship 02-507, Poland
Cheonan-si, Chungcheongnam-do 31151, South Korea
Seoul, Seoul Teugbyeolsi 03722, South Korea
Seoul, Seoul Teugbyeolsi 07441, South Korea
Basel Town, Canton of Basel-City 4031, Switzerland
London, Greater London E1 2ES, United Kingdom