A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
- Conditions
- Crohn's Disease
- Interventions
- Registration Number
- NCT06063967
- Lead Sponsor
- AbbVie
- Brief Summary
Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants.
Risankizumab is an approved drug for adults with CD. This study comprises of a Period A and a Period B. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally.
Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B. The duration of the study will be approximately 49 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 276
-
Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
-
Participant meets the following disease activity criteria:
- Moderate to severe CD as assessed by CDAI
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Period A: Risankizumab Dose A Risankizumab SC Participants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A. Period A: Placebo Placebo for risankizumab Participants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A. Period B: Risankizumab Dose B Risankizumab SC Participants randomized to receive risankizumab Dose A in Period A that achieved adequate response to receive risankizumab Dose B administered by subcutaneous (SC) injection for up to 12 weeks. Period B: Placebo Placebo for risankizumab Participants randomized to receive placebo risankizumab in Period A that achieved adequate response to continue to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks in Period B. Period B: Risankizumab Dose C Risankizumab SC Participants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B. Period C: Open-Label Risankizumab Dose D Risankizumab SC Participants who complete the Period B Week 24 visit to receive open-label risankizumab Dose D administered by subcutaneous (SC) injection for up to 52 weeks during Period C.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150) Week 12 The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150
Percentage of Participants With Endoscopic Response Week 12 The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline)
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Ulcer-Free Endoscopy Week 12 Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥ 1 at Baseline
Percentage of Participants With Endoscopic Remission Week 12 Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Week 12 The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a 5-point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Percentage of Participants with a CR-100 Clinical Response Week 4 CR-100 defined as at least a 100-point reduction from Baseline in CDAI
Percentage of Participants With Clinical Remission Week 12 Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
Trial Locations
- Locations (171)
Ege University Medical Faculty /ID# 259749
🇹🇷Izmir, Turkey
Southwest Gastroenterology /ID# 256619
🇺🇸Oak Lawn, Illinois, United States
Ankara City Hospital /ID# 261906
🇹🇷Ankara, Turkey
Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178
🇺🇸Sun City, Arizona, United States
Southern California Res. Ctr. /ID# 256612
🇺🇸Coronado, California, United States
Kindred Medical Institute - Corona /ID# 262075
🇺🇸Corona, California, United States
Valley Clinical Trials, LLC dba Flourish Research /ID# 256610
🇺🇸Covina, California, United States
Newport Huntington Medical Group /ID# 256622
🇺🇸Huntington Beach, California, United States
Om Research LLC /ID# 259645
🇺🇸Lancaster, California, United States
Om Research LLC /ID# 267523
🇺🇸Lancaster, California, United States
Clinnova Research - Orange /ID# 270138
🇺🇸Orange, California, United States
University of California, Irvine Medical Center /ID# 259677
🇺🇸Orange, California, United States
Prospective Research Innovations Inc. /ID# 267856
🇺🇸Rancho Cucamonga, California, United States
University of California San Francisco - Mission Bay /ID# 267529
🇺🇸San Francisco, California, United States
Amicis Research Center - Valencia /ID# 269158
🇺🇸Valencia, California, United States
OM Research LLC /ID# 268735
🇺🇸Victorville, California, United States
Danbury Hospital, Western Connecticut Health Network /ID# 261851
🇺🇸Danbury, Connecticut, United States
Novum Research, LLC /ID# 269223
🇺🇸Clermont, Florida, United States
Research Associates of South Florida, LLC /ID# 261627
🇺🇸Coral Gables, Florida, United States
University of Florida College of Medicine /ID# 261248
🇺🇸Gainesville, Florida, United States
Auzmer Research /ID# 261437
🇺🇸Lakeland, Florida, United States
Cfagi Llc /Id# 262005
🇺🇸Maitland, Florida, United States
Atlantic Medical Research /ID# 256471
🇺🇸Margate, Florida, United States
Homestead Associates in Research /ID# 259643
🇺🇸Miami, Florida, United States
University of Miami /ID# 256587
🇺🇸Miami, Florida, United States
JD Medical Group, LLC /ID# 262185
🇺🇸Miami, Florida, United States
Gastroenterology Group Naples /ID# 256566
🇺🇸Naples, Florida, United States
Sarkis Clinical Trials - Ocala /ID# 267840
🇺🇸Ocala, Florida, United States
Endoscopic Research, Inc. /ID# 256597
🇺🇸Orlando, Florida, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 261811
🇺🇸Orlando, Florida, United States
GCP Clinical Research, LLC /ID# 260342
🇺🇸Tampa, Florida, United States
Avita Clinical Research /ID# 261640
🇺🇸Tampa, Florida, United States
Winship Cancer Institute of Emory University /ID# 261877
🇺🇸Atlanta, Georgia, United States
Mount Vernon Clinical Research /ID# 271813
🇺🇸Atlanta, Georgia, United States
Atlanta Ctr. for Gastro /ID# 261181
🇺🇸Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 256611
🇺🇸Macon, Georgia, United States
Gastroenterology Consultants, P.C /ID# 260635
🇺🇸Roswell, Georgia, United States
Grand Teton Research Group /ID# 267521
🇺🇸Idaho Falls, Idaho, United States
The University of Chicago DCAM /ID# 256577
🇺🇸Chicago, Illinois, United States
GI Alliance - Glenview /ID# 257744
🇺🇸Glenview, Illinois, United States
GI Alliance - Gurnee /ID# 257735
🇺🇸Gurnee, Illinois, United States
IU Health University Hospital /ID# 259633
🇺🇸Indianapolis, Indiana, United States
Univ Kansas Med Ctr /ID# 262551
🇺🇸Kansas City, Kansas, United States
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 256592
🇺🇸Topeka, Kansas, United States
University of Louisville Hospital /ID# 256569
🇺🇸Louisville, Kentucky, United States
Louisiana Research Center, LLC /ID# 256598
🇺🇸Shreveport, Louisiana, United States
Portland Gastroenterology Center - Portland - Congress Street /ID# 268428
🇺🇸Portland, Maine, United States
Massachusetts General Hospital /Id# 261051
🇺🇸Boston, Massachusetts, United States
Clin Res Inst of Michigan, LLC /ID# 256609
🇺🇸Chesterfield, Michigan, United States
Clin Res Inst of Michigan, LLC /ID# 261017
🇺🇸Chesterfield, Michigan, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 256568
🇺🇸Wyoming, Michigan, United States
Mayo Clinic - Rochester /ID# 256594
🇺🇸Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City /ID# 271816
🇺🇸Kansas City, Missouri, United States
Allied Health Clinical Research Organization, LLC /ID# 261618
🇺🇸Englewood, New Jersey, United States
NY Scientific /ID# 261209
🇺🇸Brooklyn, New York, United States
Columbia University Medical Center /ID# 261879
🇺🇸New York, New York, United States
New York Gastroenterology Associates /ID# 257730
🇺🇸New York, New York, United States
Univ NC Chapel Hill /ID# 256368
🇺🇸Chapel Hill, North Carolina, United States
Carolina Research /ID# 261435
🇺🇸Greenville, North Carolina, United States
Boice-Willis Clinic, P.A. /ID# 262209
🇺🇸Rocky Mount, North Carolina, United States
Plains Clinical Research Center, LLC /ID# 256602
🇺🇸Fargo, North Dakota, United States
Optimed Research, Ltd. /ID# 256573
🇺🇸Columbus, Ohio, United States
The Ohio State University - Hilliard /ID# 256623
🇺🇸Hilliard, Ohio, United States
Hightower Clinical /ID# 256613
🇺🇸Oklahoma City, Oklahoma, United States
Options Health Research /ID# 271243
🇺🇸Tulsa, Oklahoma, United States
Gastro One /ID# 256614
🇺🇸Cordova, Tennessee, United States
Quality Medical Research /ID# 262077
🇺🇸Nashville, Tennessee, United States
Amel Med LLC. /ID# 259642
🇺🇸Austin, Texas, United States
Novel Research - Bellaire /ID# 269788
🇺🇸Bellaire, Texas, United States
University of Texas - Southwestern Medical Center /ID# 268157
🇺🇸Dallas, Texas, United States
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 256596
🇺🇸Garland, Texas, United States
Baylor College of Medicine /ID# 256600
🇺🇸Houston, Texas, United States
LinQ Research /ID# 267880
🇺🇸Houston, Texas, United States
GI Alliance/TDDC /ID# 261623
🇺🇸Lubbock, Texas, United States
North Hills Medical Research - North Richard Hills /ID# 268411
🇺🇸North Richland Hills, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC /ID# 256599
🇺🇸San Antonio, Texas, United States
Southern Star Research Institute, LLC /ID# 256601
🇺🇸San Antonio, Texas, United States
Tyler Research Institute, LLC /ID# 256595
🇺🇸Tyler, Texas, United States
GI Alliance Bay Area Gastroenterology /ID# 261866
🇺🇸Webster, Texas, United States
University Physicians and Surgeons Inc. /ID# 259636
🇺🇸Huntington, West Virginia, United States
Wisconsin Center for Advanced Research /ID# 256575
🇺🇸Milwaukee, Wisconsin, United States
Hospital Britanico de Buenos Aires /ID# 256011
🇦🇷Ciudad Autonoma de Buenos Aire, Ciudad Autonoma De Buenos Aires, Argentina
Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 256690
🇦🇷Cordoba, Argentina
L2IP Instituto de Pesquisas Clínicas /ID# 261491
🇧🇷Brasilia, Distrito Federal, Brazil
Galileo Medical Research Ltda /ID# 261493
🇧🇷Juiz de Fora, Minas Gerais, Brazil
Hospital de Clinicas de Porto Alegre /ID# 261496
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Upeclin Fmb - Unesp /Id# 261490
🇧🇷Botucatu, Sao Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 261489
🇧🇷Ribeirão Preto, Sao Paulo, Brazil
Rocco & Nazato Servicos Medicos /ID# 261497
🇧🇷São Paulo, Sao Paulo, Brazil
University of Calgary /ID# 264640
🇨🇦Calgary, Alberta, Canada
Allen Whey Khye Lim Professional Corporation /ID# 261155
🇨🇦Edmonton, Alberta, Canada
QE II Health Sciences Centre /ID# 257072
🇨🇦Halifax, Nova Scotia, Canada
Toronto Digestive Disease Associates /ID# 260532
🇨🇦Vaughan, Ontario, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 262179
🇨🇦Montreal, Quebec, Canada
Hospital Guillermo Grant Benavente de Concepción /ID# 256398
🇨🇱Concepción, Bio-Bio, Chile
Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 256397
🇨🇱Providencia, Region Metropolitana Santiago, Chile
Centros Medicos Espacioeme Spa /Id# 262844
🇨🇱Santiago, Region Metropolitana Santiago, Chile
Clinica Dermacross /ID# 260769
🇨🇱Vitacura, Region Metropolitana Santiago, Chile
Hospital Clinico Universidad De Los Andes /ID# 256856
🇨🇱Santiago, Chile
Serv Salud Metropolitano Central Hospital Clinico San Borja Arriaran /Id# 260765
🇨🇱Santiago, Chile
Chongqing General Hospital /ID# 260941
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University /ID# 260944
🇨🇳Xiamen, Fujian, China
Guangzhou First People's Hospital /ID# 260943
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 260248
🇨🇳Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 260247
🇨🇳Guangzhou, Guangdong, China
Renmin Hospital of Wuhan University /ID# 261281
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University /ID# 260938
🇨🇳Changsha, Hunan, China
Changzhou No.2 People's Hospital /ID# 260935
🇨🇳Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital /ID# 260942
🇨🇳Nanjing, Jiangsu, China
Zhongda Hospital Southeast University /ID# 260934
🇨🇳Nanjing, Jiangsu, China
Wuxi People'S Hospital /ID# 270166
🇨🇳Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University /ID# 260936
🇨🇳Nanchang, Jiangxi, China
Renji Hospital, Shanghai Jiaotong University School Of Medicine /ID# 270165
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260251
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 260246
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Henan University of Science and Technology /ID# 260933
🇨🇳Luo Yang, China
Duplicate_Clinfan Szolgaltato Kft. /ID# 260032
🇭🇺Szekszard, Tolna, Hungary
Semmelweis Egyetem /ID# 260030
🇭🇺Budapest, Hungary
The Chaim Sheba Medical Center /ID# 256251
🇮🇱Ramat Gan, Tel-Aviv, Israel
Antalya Egitim Ve Arastirma Hastanesi /ID# 259746
🇹🇷Antalya, Turkey
Shaare Zedek Medical Center /ID# 256253
🇮🇱Jerusalem, Yerushalayim, Israel
Bnai Zion Medical Center /ID# 264457
🇮🇱Haifa, Israel
Gamagori City Hospital /ID# 261372
🇯🇵Gamagori-shi, Aichi, Japan
Tsujinaka Hospital Kashiwanoha /ID# 261370
🇯🇵Kashiwa-shi, Chiba, Japan
Hyogo Medical University Hospital /ID# 261371
🇯🇵Nishinomiya-shi, Hyogo, Japan
Hamamatsu University Hospital /ID# 268612
🇯🇵Hamamatsu-shi, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 261373
🇯🇵Sunto-gun, Shizuoka, Japan
Inje University Haeundae Paik Hospital /ID# 268081
🇰🇷Busan, Busan Gwang Yeogsi, Korea, Republic of
The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 259257
🇰🇷Daejeon, Daejeon Gwang Yeogsi, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital /ID# 268080
🇰🇷Suwon, Gyeonggido, Korea, Republic of
Kangbuk Samsung Hospital /ID# 262248
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center /ID# 259255
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Gangnam Severance Hospital /ID# 270780
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 259254
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Kyungpook National University Chilgok Hospital /ID# 262449
🇰🇷Daegu, Korea, Republic of
Yonsei University Health System Severance Hospital /ID# 259256
🇰🇷Seoul, Korea, Republic of
Hospital of Lithuanian University of Health Sciences Kaunas /ID# 269630
🇱🇹Kaunas, Lithuania
Vilnius University Hospital Santaros Klinikos /ID# 269628
🇱🇹Vilnius, Lithuania
CenterMed Krakow Sp. z o.o. /ID# 273038
🇵🇱Krakow, Malopolskie, Poland
WSD MEDI Clinical Sp. z o.o. /ID# 273053
🇵🇱Warsaw, Mazowieckie, Poland
Caribbean Medical Research Center /ID# 268398
🇵🇷San Juan, Puerto Rico
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 262250
🇵🇷San Juan, Puerto Rico
King Fahad Specialist Hospital /ID# 264441
🇸🇦Ad Dammam, Saudi Arabia
King Abdulaziz Medical City- National Guard Hospital /ID# 264542
🇸🇦Riyadh, Saudi Arabia
King Saud University /ID# 264536
🇸🇦Riyadh, Saudi Arabia
King Faisal Specialist Hospital and Research Center /ID# 264539
🇸🇦Riyadh, Saudi Arabia
Clinical Hosp Center Zvezdara /ID# 256727
🇷🇸Belgrade, Beograd, Serbia
University Clinical Center Serbia /ID# 256904
🇷🇸Belgrade, Beograd, Serbia
Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 256844
🇷🇸Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 257899
🇷🇸Belgrade, Beograd, Serbia
General Hospital Leskovac /ID# 261812
🇷🇸Leskovac, Jablanicki Okrug, Serbia
Opsta Bolnica Pancevo /ID# 266881
🇷🇸Pančevo, Vojvodina, Serbia
University Clinical Center Vojvodina /ID# 256843
🇷🇸Novi Sad, Serbia
National Taiwan University Hospital /ID# 256891
🇨🇳Taipei City, Taipei, Taiwan
Show Chwan Memorial Hospital /ID# 272483
🇨🇳Changhua City, Taiwan
Chiayi Chang Gung Memorial Hospital /ID# 272484
🇨🇳Chiayi City, Taiwan
Far Eastern Memorial Hospital /ID# 256893
🇨🇳New Taipei City, Taiwan
China Medical University Hospital /ID# 256890
🇨🇳Taichung, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 256892
🇨🇳Taoyuan City, Taiwan
Gazi Universitesi Tip Fakultes /ID# 259747
🇹🇷Yenimahalle, Ankara, Turkey
Kocaeli University Research and Application Hospital /ID# 259750
🇹🇷Dilovası, Kocaeli, Turkey
Dokuz Eylul University Medical Faculty /ID# 262041
🇹🇷Izmir, Turkey
Mersin University Medical /ID# 259748
🇹🇷Mersin, Turkey
Velocity Clinical Research Ltd /ID# 271687
🇬🇧High Wycombe, Buckinghamshire, United Kingdom
Addenbrooke's Hospital /ID# 256735
🇬🇧Cambridge, Cambridgeshire, United Kingdom
Velocity North London /ID# 271900
🇬🇧North Finchley, Greater London, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 256738
🇬🇧Birmingham, United Kingdom
The Dudley Group NHS Foundation Trust /ID# 258681
🇬🇧Dudley, United Kingdom
Whiston Hospital /ID# 261449
🇬🇧Prescot, United Kingdom
Stepping Hill Hospital /ID# 259867
🇬🇧Stockport, United Kingdom
St George's University Hospitals NHS Foundation Trust /ID# 256729
🇬🇧Tooting, United Kingdom