A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
Launched by ABBVIE · Sep 26, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety and effectiveness of a medication called risankizumab for adults with moderately to severely active Crohn's disease, a long-term condition that causes serious inflammation in the digestive system. Crohn's disease can lead to symptoms like stomach pain, diarrhea, fatigue, and weight loss. In the trial, participants will receive either risankizumab or a placebo (a harmless substance with no active medication) in different phases to see how well the treatment works over time and if it has any side effects.
To be eligible for the study, participants must be adults diagnosed with Crohn's disease for at least three months and show signs of moderate to severe disease activity. They should also have had difficulties with other treatments for their condition. Throughout the study, which lasts about 93 weeks, participants will receive risankizumab injections and will be closely monitored for any changes in their symptoms and overall health. This trial aims to provide valuable information that could help improve treatment options for people living with Crohn's disease.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
- * Participant meets the following disease activity criteria:
- • 1. Moderate to severe CD as assessed by CDAI
- • 2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD
- • Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD.
- Exclusion Criteria:
- • Participants with a current diagnosis of ulcerative colitis or indeterminate colitis.
- • Participants with unstable doses of concomitant Crohn's disease therapy.
- • Participants with prior exposure to p19 inhibitors.
- • Participants with complications of Crohn's disease.
- • Participants having an ostomy or ileoanal pouch.
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
Margate, Florida, United States
Shreveport, Louisiana, United States
Fargo, North Dakota, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Naples, Florida, United States
Roswell, Georgia, United States
Chesterfield, Michigan, United States
Wyoming, Michigan, United States
Vaughan, Ontario, Canada
Miami, Florida, United States
Topeka, Kansas, United States
Orlando, Florida, United States
Macon, Georgia, United States
Columbus, Ohio, United States
Huntington Beach, California, United States
New York, New York, United States
Greenville, North Carolina, United States
Chesterfield, Michigan, United States
Milwaukee, Wisconsin, United States
Austin, Texas, United States
Ramat Gan, Tel Aviv, Israel
Coral Gables, Florida, United States
Taichung, , Taiwan
Coronado, California, United States
Jerusalem, Yerushalayim, Israel
Brooklyn, New York, United States
Gamagori Shi, Aichi, Japan
Hilliard, Ohio, United States
Tampa, Florida, United States
Chapel Hill, North Carolina, United States
Tyler, Texas, United States
Kashiwa Shi, Chiba, Japan
Taoyuan City, , Taiwan
Lakeland, Florida, United States
Miami, Florida, United States
Oklahoma City, Oklahoma, United States
Sunto Gun, Shizuoka, Japan
Daejeon, Daejeon Gwang Yeogsi, Korea, Republic Of
Nashville, Tennessee, United States
Gurnee, Illinois, United States
Glenview, Illinois, United States
Houston, Texas, United States
New Taipei City, , Taiwan
Lancaster, California, United States
Seoul, , Korea, Republic Of
Corona, California, United States
Webster, Texas, United States
Milwaukee, Wisconsin, United States
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Taipei City, , Taiwan
Garland, Texas, United States
Decatur, Georgia, United States
Englewood, New Jersey, United States
Lancaster, California, United States
Louisville, Kentucky, United States
Rochester, Minnesota, United States
Lubbock, Texas, United States
Taipei City, Taipei, Taiwan
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Cordova, Tennessee, United States
Nishinomiya Shi, Hyogo, Japan
Prescot, , United Kingdom
Covina, California, United States
Lancaster, California, United States
Orange, California, United States
Danbury, Connecticut, United States
Gainesville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
New York, New York, United States
Rocky Mount, North Carolina, United States
San Antonio, Texas, United States
Huntington, West Virginia, United States
Edmonton, Alberta, Canada
Chongqing, Chongqing, China
Guangzhou, Guangdong, China
Changzhou, Jiangsu, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Hangzhou, Zhejiang, China
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, , Korea, Republic Of
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Pomoravski Okrug, Serbia
Leskovac, Pomoravski Okrug, Serbia
Novi Sad, , Serbia
Stockport, Bolton, United Kingdom
Birmingham, , United Kingdom
North Richland Hills, Texas, United States
Guangzhou, Guangdong, China
Sun City, Arizona, United States
Rancho Cucamonga, California, United States
Ocala, Florida, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Calgary, Alberta, Canada
Guangzhou, Guangdong, China
Changsha, Guizhou, China
Nanjing, Jiangsu, China
Hangzhou, Zhejiang, China
Luo Yang, , China
Haifa, , Israel
Daegu, , Korea, Republic Of
Izmir, Adana, Turkey
Yenimahalle, Ankara, Turkey
Tooting, , United Kingdom
Mersin, , Turkey
Maitland, Florida, United States
Houston, Texas, United States
Halifax, Nova Scotia, Canada
Pančevo, Vojvodina, Serbia
Victorville, California, United States
Vaughan, Ontario, Canada
Wuhan, Hubei, China
Changsha, Hunan, China
Belgrade, Beograd, Serbia
Leskovac, Jablanicki Okrug, Serbia
Dilovası, Kocaeli, Turkey
Izmir, , Turkey
Stockport, , United Kingdom
Bellaire, Texas, United States
Providencia, Region Metropolitana Santiago, Chile
Guangzhou, Guangdong, China
Clermont, Florida, United States
Vitacura, Region Metropolitana Santiago, Chile
Orange, California, United States
Portland, Maine, United States
Santiago, , Chile
Xiamen, Fujian, China
Santiago, Region Metropolitana Santiago, Chile
Busan, Busan Gwang Yeogsi, Korea, Republic Of
Orlando, Florida, United States
Antalya, , Turkey
Cambridge, Cambridgeshire, United Kingdom
San Juan, , Puerto Rico
Dudley, , United Kingdom
Concepción, Bio Bio, Chile
Valencia, California, United States
Ankara, , Turkey
Wuxi, Jiangsu, China
Shanghai, Shanghai, China
Hamamatsu Shi, Shizuoka, Japan
San Juan, , Puerto Rico
Santiago, , Chile
Suwon, Gyeonggido, Korea, Republic Of
Oak Lawn, Illinois, United States
Tulsa, Oklahoma, United States
Hamamatsu, Shizuoka, Japan
Ribeirão Preto, Sao Paulo, Brazil
Kaunas, , Lithuania
Vilnius, , Lithuania
Izmir, , Turkey
High Wycombe, Buckinghamshire, United Kingdom
North Finchley, Greater London, United Kingdom
Ad Dammam, , Saudi Arabia
Riyadh, , Saudi Arabia
Riyadh, , Saudi Arabia
Riyadh, , Saudi Arabia
Covina, California, United States
Dallas, Texas, United States
San Francisco, California, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Atlanta, Georgia, United States
Botucatu, Sao Paulo, Brazil
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Chiayi City, , Taiwan
Cordoba, , Argentina
Juiz De Fora, Minas Gerais, Brazil
Atlanta, Georgia, United States
São Paulo, Sao Paulo, Brazil
Brasilia, Distrito Federal, Brazil
Szekszard, Tolna, Hungary
Montreal, Quebec, Canada
Kansas City, Missouri, United States
Budapest, , Hungary
Warsaw, Mazowieckie, Poland
Krakow, Malopolskie, Poland
Changhua City, , Taiwan
Ciudad Autonoma De Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Montreal, Quebec, Canada
Budapest, , Hungary
Prague, Praha 4, Czechia
Warszawa, Mazowieckie, Poland
Abu Dhabi, , United Arab Emirates
Abu Dhabi, , United Arab Emirates
Santiago, Region Metropolitana Santiago, Chile
Ceske Budejovice, , Czechia
Prague, , Czechia
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported