Clinical trial NCT06063967: A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.
Official title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Risankizumab, Skyrizi, Crohn's Disease, ABBV-066
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-03
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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, a Period B, and a Period C. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC Dose A 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. In Period C, eligible participants will receive open-label risankizumab SC Dose D. 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 followed by an open-label risankizumab extension in Period C for 52 weeks. The duration of the study will be approximately 93 weeks.


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.

Primary outcomes:
measure: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150)
timeFrame: Week 12
measure: Percentage of Participants With Endoscopic Response
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With Clinical Remission
timeFrame: Week 12
measure: Percentage of Participants With Endoscopic Remission
timeFrame: Week 12
measure: Percentage of Participants With Ulcer-Free Endoscopy
timeFrame: Week 12
measure: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
timeFrame: Week 12
measure: Percentage of Participants with a CR-100 Clinical Response
timeFrame: Week 4
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178
state: Arizona
city: Coronado
country: United States
facility: Southern California Res. Ctr. /ID# 256612
state: California
city: Corona
country: United States
facility: Kindred Medical Institute - Corona /ID# 262075
state: California
city: Covina
country: United States
facility: Valley Clinical Trials, LLC dba Flourish Research /ID# 256610
state: California
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group /ID# 256622
state: California
city: Lancaster
country: United States
facility: Om Research LLC /ID# 259645
state: California
city: Lancaster
country: United States
facility: Om Research LLC /ID# 267523
state: California
city: Orange
country: United States
facility: Clinnova Research - Orange /ID# 270138
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center /ID# 259677
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations Inc. /ID# 267856
state: California
city: San Francisco
country: United States
facility: University of California San Francisco - Mission Bay /ID# 267529
state: California
city: Valencia
country: United States
facility: Amicis Research Center - Valencia /ID# 269158
state: California
city: Victorville
country: United States
facility: OM Research LLC /ID# 268735
state: California
city: Danbury
country: United States
facility: Danbury Hospital, Western Connecticut Health Network /ID# 261851
state: Connecticut
city: Clermont
country: United States
facility: Novum Research, LLC /ID# 269223
state: Florida
city: Coral Gables
country: United States
facility: Research Associates of South Florida, LLC /ID# 261627
state: Florida
city: Gainesville
country: United States
facility: University of Florida College of Medicine /ID# 261248
state: Florida
city: Lakeland
country: United States
facility: Auzmer Research /ID# 261437
state: Florida
city: Maitland
country: United States
facility: Cfagi Llc /Id# 262005
state: Florida
city: Margate
country: United States
facility: Atlantic Medical Research /ID# 256471
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research /ID# 259643
state: Florida
city: Miami
country: United States
facility: University of Miami /ID# 256587
state: Florida
city: Miami
country: United States
facility: JD Medical Group, LLC /ID# 262185
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group Naples /ID# 256566
state: Florida
city: Ocala
country: United States
facility: Sarkis Clinical Trials - Ocala /ID# 267840
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research, Inc. /ID# 256597
state: Florida
city: Orlando
country: United States
facility: AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 261811
state: Florida
city: Tampa
country: United States
facility: GCP Clinical Research, LLC /ID# 260342
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research /ID# 261640
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University /ID# 261877
state: Georgia
city: Atlanta
country: United States
facility: Mount Vernon Clinical Research /ID# 271813
state: Georgia
city: Decatur
country: United States
facility: Atlanta Ctr. for Gastro /ID# 261181
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC /ID# 256611
state: Georgia
city: Roswell
country: United States
facility: Gastroenterology Consultants, P.C /ID# 260635
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group /ID# 267521
state: Idaho
city: Chicago
country: United States
facility: The University of Chicago DCAM /ID# 256577
state: Illinois
city: Glenview
country: United States
facility: GI Alliance - Glenview /ID# 257744
state: Illinois
city: Gurnee
country: United States
facility: GI Alliance - Gurnee /ID# 257735
state: Illinois
city: Oak Lawn
country: United States
facility: Southwest Gastroenterology /ID# 256619
state: Illinois
city: Indianapolis
country: United States
facility: IU Health University Hospital /ID# 259633
state: Indiana
city: Kansas City
country: United States
facility: Univ Kansas Med Ctr /ID# 262551
state: Kansas
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center, Digestive Health /ID# 256592
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Hospital /ID# 256569
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC /ID# 256598
state: Louisiana
city: Portland
country: United States
facility: Portland Gastroenterology Center - Portland - Congress Street /ID# 268428
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital /Id# 261051
state: Massachusetts
city: Chesterfield
country: United States
facility: Clin Res Inst of Michigan, LLC /ID# 256609
state: Michigan
city: Chesterfield
country: United States
facility: Clin Res Inst of Michigan, LLC /ID# 261017
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 256568
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 256594
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City /ID# 271816
state: Missouri
city: Englewood
country: United States
facility: Allied Health Clinical Research Organization, LLC /ID# 261618
state: New Jersey
city: Brooklyn
country: United States
facility: NY Scientific /ID# 261209
state: New York
city: New York
country: United States
facility: Columbia University Medical Center /ID# 261879
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates /ID# 257730
state: New York
city: Chapel Hill
country: United States
facility: Univ NC Chapel Hill /ID# 256368
state: North Carolina
city: Greenville
country: United States
facility: Carolina Research /ID# 261435
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice-Willis Clinic, P.A. /ID# 262209
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research Center, LLC /ID# 256602
state: North Dakota
city: Columbus
country: United States
facility: Optimed Research, Ltd. /ID# 256573
state: Ohio
city: Hilliard
country: United States
facility: The Ohio State University - Hilliard /ID# 256623
state: Ohio
city: Oklahoma City
country: United States
facility: Hightower Clinical /ID# 256613
state: Oklahoma
city: Tulsa
country: United States
facility: Options Health Research /ID# 271243
state: Oklahoma
city: Cordova
country: United States
facility: Gastro One /ID# 256614
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research /ID# 262077
state: Tennessee
city: Austin
country: United States
facility: Amel Med LLC. /ID# 259642
state: Texas
city: Bellaire
country: United States
facility: Novel Research - Bellaire /ID# 269788
state: Texas
city: Dallas
country: United States
facility: University of Texas - Southwestern Medical Center /ID# 268157
state: Texas
city: Garland
country: United States
facility: Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 256596
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine /ID# 256600
state: Texas
city: Houston
country: United States
facility: LinQ Research /ID# 267880
state: Texas
city: Lubbock
country: United States
facility: GI Alliance/TDDC /ID# 261623
state: Texas
city: North Richland Hills
country: United States
facility: North Hills Medical Research - North Richard Hills /ID# 268411
state: Texas
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 256599
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC /ID# 256601
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC /ID# 256595
state: Texas
city: Webster
country: United States
facility: GI Alliance Bay Area Gastroenterology /ID# 261866
state: Texas
city: Huntington
country: United States
facility: University Physicians and Surgeons Inc. /ID# 259636
state: West Virginia
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research /ID# 256575
state: Wisconsin
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Gedyt /ID# 258984
state: Ciudad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Britanico de Buenos Aires /ID# 256011
state: Ciudad Autonoma De Buenos Aires
city: Cordoba
country: Argentina
facility: Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 256690
city: Brasilia
country: Brazil
facility: L2IP Instituto de Pesquisas Clínicas /ID# 261491
state: Distrito Federal
city: Juiz de Fora
country: Brazil
facility: Galileo Medical Research Ltda /ID# 261493
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre /ID# 261496
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Upeclin Fmb - Unesp /Id# 261490
state: Sao Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 261489
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Rocco & Nazato Servicos Medicos /ID# 261497
state: Sao Paulo
city: Calgary
country: Canada
facility: University of Calgary /ID# 264640
state: Alberta
city: Edmonton
country: Canada
facility: Allen Whey Khye Lim Professional Corporation /ID# 261155
state: Alberta
city: Halifax
country: Canada
facility: QE II Health Sciences Centre /ID# 257072
state: Nova Scotia
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates /ID# 260532
state: Ontario
city: Montreal
country: Canada
facility: Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 262179
state: Quebec
city: Concepción
country: Chile
facility: Hospital Guillermo Grant Benavente de Concepción /ID# 256398
state: Bio-Bio
city: Providencia
country: Chile
facility: Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 256397
state: Region Metropolitana Santiago
city: Santiago
country: Chile
facility: Centros Medicos Espacioeme Spa /Id# 262844
state: Region Metropolitana Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile /ID# 256935
state: Region Metropolitana Santiago
city: Vitacura
country: Chile
facility: Clinica Dermacross /ID# 260769
state: Region Metropolitana Santiago
city: Santiago
country: Chile
facility: Hospital Clinico Universidad De Los Andes /ID# 256856
city: Santiago
country: Chile
facility: Serv Salud Metropolitano Central Hospital Clinico San Borja Arriaran /Id# 260765
city: Chongqing
country: China
facility: Chongqing General Hospital /ID# 260941
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University /ID# 260944
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital /ID# 260943
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University /ID# 260248
state: Guangdong
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 260247
state: Guangdong
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University /ID# 261281
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University /ID# 260938
state: Hunan
city: Changzhou
country: China
facility: Changzhou No.2 People's Hospital /ID# 260935
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital /ID# 260942
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 260934
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People'S Hospital /ID# 270166
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 260936
state: Jiangxi
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School Of Medicine /ID# 270165
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260251
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 260246
state: Zhejiang
city: Luo Yang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology /ID# 260933
city: Prague
country: Czechia
facility: Fakultni Thomayerova nemocnice /ID# 272944
state: Praha 4
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a.s. /ID# 256414
city: Szekszard
country: Hungary
facility: Duplicate_Clinfan Szolgaltato Kft. /ID# 260032
state: Tolna
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 260030
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 274289
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 256251
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 256253
state: Yerushalayim
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 264457
city: Gamagori-shi
country: Japan
facility: Gamagori City Hospital /ID# 261372
state: Aichi
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha /ID# 261370
state: Chiba
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital /ID# 261371
state: Hyogo
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 268612
state: Shizuoka
city: Sunto-gun
country: Japan
facility: NHO Shizuoka Medical Center /ID# 261373
state: Shizuoka
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital /ID# 268081
state: Busan Gwang Yeogsi
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 259257
state: Daejeon Gwang Yeogsi
city: Suwon
country: Korea, Republic of
facility: The Catholic University Of Korea St. Vincent's Hospital /ID# 268080
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital /ID# 262248
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 259255
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 270780
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 259254
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital /ID# 262449
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 259256
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas /ID# 269630
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos /ID# 269628
city: Krakow
country: Poland
facility: CenterMed Krakow Sp. z o.o. /ID# 273038
state: Malopolskie
city: Warsaw
country: Poland
facility: WSD MEDI Clinical Sp. z o.o. /ID# 273053
state: Mazowieckie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 273024
state: Mazowieckie
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center /ID# 268398
city: San Juan
country: Puerto Rico
facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 262250
city: Ad Dammam
country: Saudi Arabia
facility: King Fahad Specialist Hospital /ID# 264441
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City- National Guard Hospital /ID# 264542
city: Riyadh
country: Saudi Arabia
facility: King Saud University /ID# 264536
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Center /ID# 264539
city: Belgrade
country: Serbia
facility: Clinical Hosp Center Zvezdara /ID# 256727
state: Beograd
city: Belgrade
country: Serbia
facility: University Clinical Center Serbia /ID# 256904
state: Beograd
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 256844
state: Beograd
city: Belgrade
country: Serbia
facility: Clin Hosp Ctr Bezanijska Kosa /ID# 257899
state: Beograd
city: Leskovac
country: Serbia
facility: General Hospital Leskovac /ID# 261812
state: Jablanicki Okrug
city: Pančevo
country: Serbia
facility: Opsta Bolnica Pancevo /ID# 266881
state: Vojvodina
city: Novi Sad
country: Serbia
facility: University Clinical Center Vojvodina /ID# 256843
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 256891
state: Taipei
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital /ID# 272483
city: Chiayi City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital /ID# 272484
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital /ID# 256893
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 256890
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital /ID# 256892
city: Yenimahalle
country: Turkey
facility: Gazi Universitesi Tip Fakultes /ID# 259747
state: Ankara
city: Dilovası
country: Turkey
facility: Kocaeli University Research and Application Hospital /ID# 259750
state: Kocaeli
city: Ankara
country: Turkey
facility: Ankara City Hospital /ID# 261906
city: Antalya
country: Turkey
facility: Antalya Egitim Ve Arastirma Hastanesi /ID# 259746
city: Izmir
country: Turkey
facility: Ege University Medical Faculty /ID# 259749
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty /ID# 262041
city: Mersin
country: Turkey
facility: Mersin University Medical /ID# 259748
city: Abu Dhabi
country: United Arab Emirates
facility: Burjeel Medical City /ID# 269671
city: Abu Dhabi
country: United Arab Emirates
facility: Sheikh Shakhbout Medical City /ID# 269680
city: High Wycombe
country: United Kingdom
facility: Velocity Clinical Research Ltd /ID# 271687
state: Buckinghamshire
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital /ID# 256735
state: Cambridgeshire
city: North Finchley
country: United Kingdom
facility: Velocity North London /ID# 271900
state: Greater London
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust /ID# 256738
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust /ID# 258681
city: Prescot
country: United Kingdom
facility: Whiston Hospital /ID# 261449
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital /ID# 259867
city: Tooting
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust /ID# 256729
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: