AzTrials
AzTrials

Crohn's DiseasePhase 3AFFIRMNCT06063967

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease.

A Phase 3 study testing Risankizumab SC in people with Crohn's Disease, run by AbbVie at 179 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Risankizumab SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
289 participants
Where
179 sitesin 20 countries
Study dates
15 Nov 2023to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

179 sites in 20 countries.

179 sites in 20 countries

United States79 sites

  • Winship Cancer Institute of Emory University /ID# 261877

    Atlanta, Georgia, 30322

  • Mount Vernon Clinical Research /ID# 271813

    Atlanta, Georgia, 30328

  • Amel Med LLC. /ID# 259642

    Austin, Texas, 78705

  • Novel Research - Bellaire /ID# 269788

    Bellaire, Texas, 77401

  • Massachusetts General Hospital /Id# 261051

    Boston, Massachusetts, 02114

  • NY Scientific /ID# 261209

    Brooklyn, New York, 11235-3919

  • Univ NC Chapel Hill /ID# 256368

    Chapel Hill, North Carolina, 27514-4220

  • Clin Res Inst of Michigan, LLC /ID# 256609

    Chesterfield, Michigan, 48047

  • Clin Res Inst of Michigan, LLC /ID# 261017

    Chesterfield, Michigan, 48047

  • Duplicate_The University of Chicago DCAM /ID# 256577

    Chicago, Illinois, 60637

  • Novum Research /ID# 269223

    Clermont, Florida, 34711

  • Optimed Research, Ltd. /ID# 256573

    Columbus, Ohio, 43235

  • Research Associates of South Florida, LLC /ID# 261627

    Coral Gables, Florida, 33134-2442

  • Gastro One /ID# 256614

    Cordova, Tennessee, 38018

  • Kindred Medical Institute - Corona /ID# 262075

    Corona, California, 92879-3104

  • Southern California Res. Ctr. /ID# 256612

    Coronado, California, 92118-1408

  • Valley Clinical Trials, LLC dba Flourish Research /ID# 256610

    Covina, California, 91723

  • University of Texas - Southwestern Medical Center /ID# 268157

    Dallas, Texas, 75235

  • Danbury Hospital, Western Connecticut Health Network /ID# 261851

    Danbury, Connecticut, 06810

  • Atlanta Ctr. for Gastro /ID# 261181

    Decatur, Georgia, 30033

  • Allied Health Clinical Research Organization, LLC /ID# 261618

    Englewood, New Jersey, 07631-4152

  • Plains Clinical Research Center, LLC /ID# 256602

    Fargo, North Dakota, 58104-5925

  • University of Florida College of Medicine /ID# 261248

    Gainesville, Florida, 32610

  • Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 256596

    Garland, Texas, 75044

  • GI Alliance - Glenview /ID# 257744

    Glenview, Illinois, 60026-8000

  • Carolina Research /ID# 261435

    Greenville, North Carolina, 27834

  • GI Alliance - Gurnee /ID# 257735

    Gurnee, Illinois, 60031-5711

  • The Ohio State University - Hilliard /ID# 256623

    Hilliard, Ohio, 43210

  • Baylor College of Medicine /ID# 256600

    Houston, Texas, 77030

  • LinQ Research /ID# 267880

    Houston, Texas, 77087

  • University Physicians and Surgeons Inc. /ID# 259636

    Huntington, West Virginia, 25701

  • Newport Huntington Medical Group /ID# 256622

    Huntington Beach, California, 92648-5994

  • Grand Teton Research Group /ID# 267521

    Idaho Falls, Idaho, 83404

  • IU Health University Hospital /ID# 259633

    Indianapolis, Indiana, 46202-5149

  • Univ Kansas Med Ctr /ID# 262551

    Kansas City, Kansas, 66160

  • Saint Lukes Hospital of Kansas City /ID# 271816

    Kansas City, Missouri, 64111

  • Auzmer Research /ID# 261437

    Lakeland, Florida, 33813-4924

  • Om Research LLC /ID# 259645

    Lancaster, California, 93534

  • Om Research LLC /ID# 267523

    Lancaster, California, 93534

  • University of Louisville Hospital /ID# 256569

    Louisville, Kentucky, 40202

  • GI Alliance/TDDC /ID# 261623

    Lubbock, Texas, 79410-2014

  • Gastroenterology Associates of Central Georgia, LLC /ID# 256611

    Macon, Georgia, 31201

  • Cfagi Llc /Id# 262005

    Maitland, Florida, 32751-6108

  • Atlantic Medical Research /ID# 256471

    Margate, Florida, 33063-5737

  • Homestead Associates in Research /ID# 259643

    Miami, Florida, 33032

  • University of Miami /ID# 256587

    Miami, Florida, 33136

  • JD Medical Group, LLC /ID# 262185

    Miami, Florida, 33176-2302

  • Wisconsin Center for Advanced Research /ID# 256575

    Milwaukee, Wisconsin, 53215

  • Gastroenterology Group Naples /ID# 256566

    Naples, Florida, 34102

  • Quality Medical Research /ID# 262077

    Nashville, Tennessee, 37211

  • Columbia University Medical Center /ID# 261879

    New York, New York, 10032-3729

  • New York Gastroenterology Associates /ID# 257730

    New York, New York, 10075

  • North Hills Medical Research - North Richard Hills /ID# 268411

    North Richland Hills, Texas, 76180

  • Southwest Gastroenterology /ID# 256619

    Oak Lawn, Illinois, 60453

  • Sarkis Clinical Trials - Ocala /ID# 267840

    Ocala, Florida, 34474

  • Hightower Clinical /ID# 256613

    Oklahoma City, Oklahoma, 73102

  • Clinnova Research - Orange /ID# 270138

    Orange, California, 92868

  • University of California, Irvine Medical Center /ID# 259677

    Orange, California, 92868

  • Endoscopic Research, Inc. /ID# 256597

    Orlando, Florida, 32803

  • AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 261811

    Orlando, Florida, 32804-5505

  • Portland Gastroenterology Center - Portland - Congress Street /ID# 268428

    Portland, Maine, 04102

  • Prospective Research Innovations Inc. /ID# 267856

    Rancho Cucamonga, California, 91730

  • Mayo Clinic - Rochester /ID# 256594

    Rochester, Minnesota, 55905-0001

  • Boice-Willis Clinic, P.A. /ID# 262209

    Rocky Mount, North Carolina, 27804

  • Gastroenterology Consultants, P.C /ID# 260635

    Roswell, Georgia, 30076-4913

  • Clinical Associates in Research Therapeutics of America, LLC /ID# 256599

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC /ID# 256601

    San Antonio, Texas, 78229-5390

  • University of California San Francisco - Mission Bay /ID# 267529

    San Francisco, California, 94158

  • Louisiana Research Center, LLC /ID# 256598

    Shreveport, Louisiana, 71105-6800

  • Gi Alliance - Arizona Digestive Health - Sun City /ID# 268178

    Sun City, Arizona, 85351

  • GCP Clinical Research, LLC /ID# 260342

    Tampa, Florida, 33609

  • Avita Clinical Research /ID# 261640

    Tampa, Florida, 33613-1825

  • Cotton O'Neil Clinical Research Center, Digestive Health /ID# 256592

    Topeka, Kansas, 66606

  • Options Health Research /ID# 271243

    Tulsa, Oklahoma, 74104

  • Tyler Research Institute, LLC /ID# 256595

    Tyler, Texas, 75701

  • Amicis Research Center - Valencia /ID# 269158

    Valencia, California, 91355

  • OM Research LLC /ID# 268735

    Victorville, California, 92395

  • GI Alliance Bay Area Gastroenterology /ID# 261866

    Webster, Texas, 77598-4052

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 256568

    Wyoming, Michigan, 49519

Other trials in United States

China16 sites

  • The Second Xiangya Hospital Of Central South University /ID# 260938

    Changsha, Hunan, 410011

  • Changzhou No.2 Peoples Hospital /ID# 260935

    Changzhou, Jiangsu, 213000

  • Chongqing General Hospital /ID# 260941

    Chongqing, Chongqing Municipality, 400013

  • Guangzhou First People's Hospital /ID# 260943

    Guangzhou, Guangdong, 510180

  • Nanfang Hospital of Southern Medical University /ID# 260248

    Guangzhou, Guangdong, 510515

  • The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 260247

    Guangzhou, Guangdong, 510655

  • The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260251

    Hangzhou, Zhejiang, 310003

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 260246

    Hangzhou, Zhejiang, 310018

  • The First Affiliated Hospital of Henan University of Science and Technology /ID# 260933

    Luoyang, 471000

  • The First Affiliated Hospital of Nanchang University /ID# 260936

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital /ID# 260942

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University /ID# 260934

    Nanjing, Jiangsu, 210009

  • Renji Hospital, Shanghai Jiaotong University School Of Medicine /ID# 270165

    Shanghai, Shanghai Municipality, 200127

  • Renmin Hospital of Wuhan University /ID# 261281

    Wuhan, Hubei, 430060

  • Wuxi PeopleS Hospital /ID# 270166

    Wuxi, Jiangsu, 214023

  • The First Affiliated Hospital of Xiamen University /ID# 260944

    Xiamen, Fujian, 361003

Other trials in China

South Korea9 sites

  • Inje University Haeundae Paik Hospital /ID# 268081

    Busan, Busan Gwang Yeogsi, 48108

  • Kyungpook National University Chilgok Hospital /ID# 262449

    Daegu, 41404

  • The Catholic University of Korea, Daejeon St. Mary's Hospital /ID# 259257

    Daejeon, Daejeon Gwang Yeogsi, 34943

  • Kangbuk Samsung Hospital /ID# 262248

    Seoul, Seoul Teugbyeolsi, 03181

  • Asan Medical Center /ID# 259255

    Seoul, Seoul Teugbyeolsi, 05505

  • Gangnam Severance Hospital /ID# 270780

    Seoul, Seoul Teugbyeolsi, 06273

  • Samsung Medical Center /ID# 259254

    Seoul, Seoul Teugbyeolsi, 06351

  • Yonsei University Health System Severance Hospital /ID# 259256

    Seoul, 03722

  • The Catholic University Of Korea St. Vincent's Hospital /ID# 268080

    Suwon, Gyeonggido, 16247

Other trials in South Korea

United Kingdom8 sites

  • University Hospitals Birmingham NHS Foundation Trust /ID# 256738

    Birmingham, B15 2TH

  • Addenbrookes Hospital /ID# 256735

    Cambridge, Cambridgeshire, CB2 2QQ

  • The Dudley Group NHS Foundation Trust /ID# 258681

    Dudley, DY1 2HQ

  • Velocity Clinical Research Ltd /ID# 271687

    High Wycombe, Buckinghamshire, HP11 2QW

  • St George University Hospitals NHS Foundation Trust /ID# 256729

    London, Greater London, SW17 0QT

  • Velocity North London /ID# 271900

    North Finchley, Greater London, N12 8BU

  • Whiston Hospital /ID# 261449

    Prescot, L35 5DR

  • Stepping Hill Hospital /ID# 259867

    Stockport, SK2 7JE

Other trials in United Kingdom

Chile7 sites

  • Hospital Guillermo Grant Benavente de Concepción /ID# 256398

    Concepción, Biobio, 4070038

  • Sociedad de Servicios Medicos Walsen Galmez Ltda. /ID# 256397

    Providencia, Region Metropolitana Santiago, 7510086

  • Centros Medicos Espacioeme Spa /Id# 262844

    Santiago, Region Metropolitana Santiago, 7770086

  • Pontificia Universidad Catolica de Chile /ID# 256935

    Santiago, Region Metropolitana Santiago, 8331150

  • Serv Salud Metropolitano Central Hospital Clinico San Borja Arriaran /Id# 260765

    Santiago, Region Metropolitana Santiago, 8360156

  • Hospital Clinico Universidad De Los Andes /ID# 256856

    Santiago, 7501504

  • Clinica Dermacross /ID# 260769

    Vitacura, Region Metropolitana Santiago, 7640881

Other trials in Chile

Serbia7 sites

  • Clinical Hosp Center Zvezdara /ID# 256727

    Belgrade, Beograd, 11000

  • University Clinical Center Serbia /ID# 256904

    Belgrade, Beograd, 11000

  • Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 256844

    Belgrade, Beograd, 11040

  • Clin Hosp Ctr Bezanijska Kosa /ID# 257899

    Belgrade, Beograd, 11080

  • General Hospital Leskovac /ID# 261812

    Leskovac, Jablanicki Okrug, 16000

  • University Clinical Center Vojvodina /ID# 256843

    Novi Sad, 21000

  • Opsta Bolnica Pancevo /ID# 266881

    Pančevo, Vojvodina, 26101

Other trials in Serbia

Turkey (Türkiye)7 sites

  • Ankara City Hospital /ID# 261906

    Ankara, 06800

  • Antalya Egitim Ve Arastirma Hastanesi /ID# 259746

    Antalya, 07100

  • Kocaeli University Research and Application Hospital /ID# 259750

    Dilovası, Kocaeli, 41455

  • Ege University Medical Faculty /ID# 259749

    Izmir, 35040

  • Dokuz Eylul University Medical Faculty /ID# 262041

    Izmir, 35340

  • Mersin University Medical /ID# 259748

    Mersin, 33343

  • Gazi Universitesi Tip Fakultes /ID# 259747

    Yenimahalle, Ankara, 06560

Other trials in Turkey (Türkiye)

Brazil6 sites

  • Upeclin Fmb - Unesp /Id# 261490

    Botucatu, São Paulo, 18618-686

  • L2ip - Instituto De Pesquisas Clínicas /ID# 261491

    Brasília, Federal District, 70200-730

  • Galileo Medical Research Ltda /ID# 261493

    Juiz de Fora, Minas Gerais, 36033-318

  • Hospital de Clinicas de Porto Alegre /ID# 261496

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 261489

    Ribeirão Preto, São Paulo, 14049-900

  • Rocco & Nazato Servicos Medicos /ID# 261497

    São Paulo, São Paulo, 04543-011

Other trials in Brazil

Taiwan6 sites

  • Show Chwan Memorial Hospital /ID# 272483

    Changhua, 500

  • Chiayi Chang Gung Memorial Hospital /ID# 272484

    Chiayi City, 613

  • Far Eastern Memorial Hospital /ID# 256893

    New Taipei City, 22060

  • China Medical University Hospital /ID# 256890

    Taichung, 40447

  • National Taiwan University Hospital /ID# 256891

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 256892

    Taoyuan City, 333

Other trials in Taiwan

Canada5 sites

  • University of Calgary /ID# 264640

    Calgary, Alberta, T2N 4Z6

  • Allen Whey Khye Lim Professional Corporation /ID# 261155

    Edmonton, Alberta, T5R 1W2

  • Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 257072

    Halifax, Nova Scotia, B3H 2Y9

  • Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 262179

    Montreal, Quebec, H4A 3J1

  • Toronto Digestive Disease Associates /ID# 260532

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Japan5 sites

  • Gamagori City Hospital /ID# 261372

    Gamagori-shi, Aichi-ken, 443-8501

  • Hamamatsu University Hospital /ID# 268612

    Hamamatsu, Shizuoka, 431-3192

  • Tsujinaka Hospital - Kashiwanoha /ID# 261370

    Kashiwa-shi, Chiba, 277-0871

  • Hyogo Medical University Hospital /ID# 261371

    Nishinomiya-shi, Hyōgo, 663-8501

  • NHO Shizuoka Medical Center /ID# 261373

    Sunto-gun, Shizuoka, 411-8611

Other trials in Japan

Saudi Arabia4 sites

  • King Fahad Specialist Hospital /ID# 264441

    Dammam, 32253

  • King Abdulaziz Medical City- National Guard Hospital /ID# 264542

    Riyadh, 11426

  • King Saud University /ID# 264536

    Riyadh, 12372

  • King Faisal Specialist Hospital and Research Center /ID# 264539

    Riyadh, 12713

Other trials in Saudi Arabia

Argentina3 sites

  • Hospital Britanico de Buenos Aires /ID# 256011

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1280

  • Gedyt /ID# 258984

    Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., 1115

  • Hospital Privado Universitario - Hospital Privado Centro Medico de Cordoba S.A. /ID# 256690

    Córdoba, 5016

Other trials in Argentina

Hungary3 sites

  • Semmelweis Egyetem /ID# 260030

    Budapest, 1085

  • Semmelweis Egyetem /ID# 274289

    Budapest, 1085

  • Duplicate_Clinfan Szolgaltato Kft. /ID# 260032

    Szekszárd, Tolna County, 7100

Other trials in Hungary

Israel3 sites

  • Bnai Zion Medical Center /ID# 264457

    Haifa, 3104802

  • Shaare Zedek Medical Center /ID# 256253

    Jerusalem, Jerusalem, 91031

  • The Chaim Sheba Medical Center /ID# 256251

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Poland3 sites

  • CenterMed Krakow Sp. z o.o. /ID# 273038

    Krakow, Lesser Poland Voivodeship, 31-530

  • Panstwowy Instytut Medyczny MSWiA /ID# 273024

    Warsaw, Masovian Voivodeship, 02-507

  • WSD MEDI Clinical Sp. z o.o. /ID# 273053

    Warsaw, Masovian Voivodeship, 02-786

Other trials in Poland

Czechia2 sites

  • Nemocnice Ceske Budejovice a.s. /ID# 256414

    České Budějovice, 370 01

  • Fakultni Thomayerova nemocnice /ID# 272944

    Prague, Praha 4, 140 00

Other trials in Czechia

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 269630

    Kaunas, 50161

  • Vilnius University Hospital Santaros Klinikos /ID# 269628

    Vilnius, 08661

Other trials in Lithuania

Puerto Rico2 sites

  • Caribbean Medical Research Center /ID# 268398

    San Juan, 00918-3501

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 262250

    San Juan, 00935

Other trials in Puerto Rico

United Arab Emirates2 sites

  • Burjeel Medical City /ID# 269671

    Abu Dhabi, 0

  • Sheikh Shakhbout Medical City /ID# 269680

    Abu Dhabi, 11001

Other trials in United Arab Emirates

About this study

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

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.

Conditions
Crohn's Disease
Being tested
Risankizumab SC, Placebo for risankizumab
Keywords
Risankizumab, Skyrizi, Crohn's Disease, ABBV-066
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risankizumab SCDrug

    Also called ABBV-066, SKYRIZI

    subcutaneous (SC) injection

  • Placebo for risankizumabDrug

    subcutaneous (SC) injection

Study groups in NCT06063967
Study groupRoleWhat they receive
Period A: Risankizumab Dose AExperimentalParticipants randomized to receive risankizumab Dose A administered by subcutaneous (SC) injection for up to 12 weeks during Period A.
Receives: Drug: Risankizumab SC
Period A: PlaceboPlacebo comparatorParticipants randomized to receive placebo for risankizumab administered by Subcutaneous (SC) injection for up to 12 weeks during Period A.
Receives: Drug: Placebo for risankizumab
Period B: Risankizumab Dose BExperimentalParticipants 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.
Receives: Drug: Risankizumab SC
Period B: PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo for risankizumab
Period B: Risankizumab Dose CExperimentalParticipants with inadequate response in Period A to receive Dose C administered by Subcutaneous (SC) injection for up to 12 weeks during Period B.
Receives: Drug: Risankizumab SC
Period C: Open-Label Risankizumab Dose DExperimentalParticipants 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.
Receives: Drug: Risankizumab SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150)

    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

    Measured: Week 12

  2. Percentage of Participants With Endoscopic Response

    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)

    Measured: Week 12

  3. Number of Participants Experiencing Adverse Events

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Measured: Up to approximately 96 weeks

Secondary outcomes (5)

  1. Percentage of Participants With Clinical Remission

    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.

    Measured: Week 12

  2. Percentage of Participants With Endoscopic Remission

    Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable

    Measured: Week 12

  3. Percentage of Participants With Ulcer-Free Endoscopy

    Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in participants with SES-CD ulcerated surface subscore ≥ 1 at Baseline

    Measured: Week 12

  4. Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue

    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.

    Measured: Week 12

  5. Percentage of Participants with a CR-100 Clinical Response

    CR-100 defined as at least a 100-point reduction from Baseline in CDAI

    Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start15 Nov 2023
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06063967
Sponsor's protocol ID
M23-784
Other IDs
2024-516023-13-00
Acronym
AFFIRM
Status last verified
Sep 2025
First submitted
26 Sep 2023
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab SC in people with Crohn's Disease, run by AbbVie at 179 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States, China, South Korea, United Kingdom, Chile and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission (CDAI < 150) (time frame: Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06063967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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