AzTrials
AzTrials

Crohn's DiseasePhase 2AIM-CDNCT05068284

A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease

A Phase 2 study testing ABBV-154 in people with Crohn's Disease, run by AbbVie at 166 sites in 24 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
ABBV-154
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
166 sitesin 24 countries
Study dates
31 Jan 2022to 20 Jul 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to Baseline of the Induction Period.
  • Crohn's Disease Activity Index (CDAI) score 220 to 450 at Baseline of the Induction Period.
  • Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of >= 6 for ileocolonic or colonic disease or SES-CD of >= 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component.
  • Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or risankizumab.

Who cannot join

  • Participants with prior intolerance to adalimumab.

Trial locations and contacts

166 sites in 24 countries.

166 sites in 24 countries

United States45 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 233765

    Ann Arbor, Michigan, 48109

  • Emory University /ID# 241014

    Atlanta, Georgia, 30322-1013

  • AGILE Clinical Research Trials /ID# 233739

    Atlanta, Georgia, 30328-5532

  • University of Colorado Hospital /ID# 239361

    Aurora, Colorado, 80045

  • Northshore Gastroentrology Research LLC /ID# 239307

    Brooklyn, Ohio, 44144

  • Univ NC Chapel Hill /ID# 233557

    Chapel Hill, North Carolina, 27514-4220

  • The University of Chicago DCAM /ID# 233824

    Chicago, Illinois, 60637

  • University of Cincinnati /ID# 234237

    Cincinnati, Ohio, 45267-0585

  • Gastro One /ID# 239748

    Cordova, Tennessee, 38018

  • Southern California Res. Ctr. /ID# 233512

    Coronado, California, 92118-1408

  • Digestive Health Specialists of the Southeast /ID# 239599

    Dothan, Alabama, 36305

  • Digestive Health Services /ID# 241177

    Downers Grove, Illinois, 60515-1552

  • Allied Health Clinical Research Organization, LLC /ID# 241935

    Englewood, New Jersey, 07631-4152

  • Gastro Health Research /ID# 240085

    Fairfax, Virginia, 22031-4622

  • Gastroenterology Associates, P.A. of Greenville /ID# 233544

    Greenville, South Carolina, 29607

  • Medical Research Center of CT /ID# 233542

    Hamden, Connecticut, 06518

  • Hoag Memorial Hosp Presbyterian /ID# 233555

    Irvine, California, 92618

  • Las Vegas Medical Research /ID# 233826

    Las Vegas, Nevada, 89113

  • University of Louisville /ID# 233766

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia, LLC /ID# 245604

    Macon, Georgia, 31201

  • Atlantic Medical Research /ID# 233506

    Margate, Florida, 33063-5737

  • GI Specialists of GA, PC /ID# 239261

    Marietta, Georgia, 30060

  • University of Miami /ID# 233811

    Miami, Florida, 33136

  • East View Medical Research, LLC /ID# 240030

    Mobile, Alabama, 36606

  • Gastroenterology Group Naples /ID# 233829

    Naples, Florida, 34102

  • The Mount Sinai Hospital /ID# 233823

    New York, New York, 10029

  • Lenox Hill Hospital /ID# 239312

    New York, New York, 10075

  • New York Gastroenterology Associates /ID# 241967

    New York, New York, 10075

  • Southwest Gastroenterology /ID# 234278

    Oak Lawn, Illinois, 60453

  • Hightower Clinical /ID# 239598

    Oklahoma City, Oklahoma, 73102

  • Digestive Disease Specialists /ID# 233825

    Oklahoma City, Oklahoma, 73112

  • Digestive Disease Consultants - Orange Park /ID# 241015

    Orange Park, Florida, 32073

  • Endoscopic Research, Inc. /ID# 234279

    Orlando, Florida, 32803

  • IMIC Inc. Medical Research /ID# 233821

    Palmetto Bay, Florida, 33157

  • University of Pennsylvania /ID# 239291

    Philadelphia, Pennsylvania, 19104-5502

  • Allegheny Health Network Research Institute /ID# 239334

    Pittsburgh, Pennsylvania, 15224

  • Hunter Holmes McGuire VA Medical Center /ID# 233759

    Richmond, Virginia, 23249

  • Mayo Clinic - Rochester /ID# 238516

    Rochester, Minnesota, 55905-0001

  • Gastroenterology Consultants, P.C /ID# 233552

    Roswell, Georgia, 30076-4913

  • University of Utah Hospitals and Clinics /ID# 239264

    Salt Lake City, Utah, 84132-0001

  • Southern Star Research Institute, LLC /ID# 240132

    San Antonio, Texas, 78229-5390

  • Louisiana Research Center, LLC /ID# 245370

    Shreveport, Louisiana, 71105-6800

  • Tyler Research Institute, LLC /ID# 233730

    Tyler, Texas, 75701-4464

  • Gastro Health & Nutrition - Victoria /ID# 240158

    Victoria, Texas, 77904

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 233763

    Wyoming, Michigan, 49519

Other trials in United States

Japan31 sites

  • Asahikawa City Hospital /ID# 248061

    Asahikawa-shi, Hokkaido, 070-8610

  • Tokyo Medical And Dental University Hospital /ID# 238950

    Bunkyo-ku, Tokyo, 113-8519

  • Fukushima Medical University Hospital /ID# 239314

    Fukushima, Fukushima, 960-1295

  • Hamamatsu University Hospital /ID# 238527

    Hamamatsu, Shizuoka, 431-3192

  • Hiroshima University Hospital /ID# 238947

    Hiroshima, Hiroshima, 734-8551

  • Kanazawa University Hospital /ID# 239670

    Kanazawa, Ishikawa-ken, 920-8641

  • Tsujinaka Hospital Kashiwanoha /ID# 239012

    Kashiwa-shi, Chiba, 277-0871

  • St. Marianna University Hospital /ID# 239167

    Kawasaki-shi, Kanagawa, 216-8511

  • University Hospital Kyoto Prefectural University of Medicine /ID# 239918

    Kyoto, Kyoto, 602-8566

  • Gunma University Hospital /ID# 239913

    Maebashi, Gunma, 371-8511

  • Kyorin University Hospital /ID# 239609

    Mitaka-shi, Tokyo, 181-8611

  • Iwate Medical University Uchimaru Medical Center /ID# 238953

    Morioka, Iwate, 020-8505

  • Aichi Medical University Hospital /ID# 238528

    Nagakute-shi, Aichi-ken, 480-1195

  • Daido Clinic /ID# 239730

    Nagoya, Aichi-ken, 457-8511

  • Nagoya University Hospital /ID# 238662

    Nagoya, Aichi-ken, 4668560

  • Nagoya City University Hospital /ID# 238368

    Nagoya, Aichi-ken, 467-8602

  • Hyogo Medical University Hospital /ID# 239049

    Nishinomiya-shi, Hyōgo, 663-8501

  • Okayama University Hospital /ID# 239757

    Okayama, Okayama-ken, 700-8558

  • Osaka Metropolitan University Hospital /ID# 238638

    Osaka, Osaka, 545-8586

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 238791

    Sapporo, Hokkaido, 060-0033

  • Sapporo Medical University Hospital /ID# 239201

    Sapporo, Hokkaido, 060-8543

  • Sapporo IBD Clinic /ID# 239054

    Sapporo, Hokkaido, 064-0919

  • Tohoku University Hospital /ID# 238476

    Sendai, Miyagi, 9808574

  • Tokyo Medical University Hospital /ID# 239668

    Shinjuku-ku, Tokyo, 160-0023

  • Center hospital of the National Center for Global Health and Medicine /ID# 239792

    Shinjuku-ku, Tokyo, 162-8655

  • Tokyo Women's Medical University Hospital /ID# 239760

    Shinjuku-ku, Tokyo, 162-8666

  • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 239554

    Shinjuku-ku, Tokyo, 169-0073

  • Osaka University Hospital /ID# 240485

    Suita-shi, Osaka, 565-0871

  • NHO Shizuoka Medical Center /ID# 239759

    Sunto-gun, Shizuoka, 411-8611

  • Mie University Hospital /ID# 239758

    Tsu, Mie-ken, 514-8507

  • Yamagata University Hospital /ID# 239572

    Yamagata, Yamagata, 990-9585

Other trials in Japan

Germany10 sites

  • DRK Kliniken Berlin Westend /ID# 233718

    Berlin, 14050

  • Universitaetsklinikum Erlangen /ID# 233529

    Erlangen, Bavaria, 91054

  • Universitaetsklinikum Freiburg /ID# 233719

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Medizinische Hochschule Hannover /ID# 238804

    Hanover, 30625

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 233527

    Kiel, Schleswig-Holstein, 24105

  • EUGASTRO GmbH /ID# 233717

    Leipzig, 04103

  • Klinikum Lueneburg /ID# 233720

    Lüneburg, 21339

  • Universitatsklinikum Mannheim /ID# 233716

    Mannheim, Baden-Wurttemberg, 68167

  • Universitatsklinik Regensburg /ID# 238702

    Regensburg, Bavaria, 93053

  • Universitaetsklinikum Ulm /ID# 233531

    Ulm, Baden-Wurttemberg, 89081

Other trials in Germany

Canada7 sites

  • University of Calgary /ID# 233838

    Calgary, Alberta, T2N 4Z6

  • Gastroenterology and Internal Medicine Research Institution /ID# 233831

    Edmonton, Alberta, T5R 1W2

  • QE II Health Sciences Centre /ID# 233839

    Halifax, Nova Scotia, B3H 1V7

  • London Health Sciences Center- University Hospital /ID# 234058

    London, Ontario, N6A 5W9

  • Scott Shulman Medicine Professional Corporation /ID# 239567

    North Bay, Ontario, P1B 2H3

  • Toronto Immune and Digestive Health Institute Inc /ID# 234142

    North York, Ontario, M6A 3B4

  • Toronto Digestive Disease Associates, Inc. /ID# 234143

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Australia6 sites

  • Royal Adelaide Hospital /ID# 233705

    Adelaide, South Australia, 5000

  • Monash Medical Centre /ID# 233469

    Clayton, Victoria, 3168

  • Concord Repatriation General /ID# 233467

    Concord, New South Wales, 2139

  • Fiona Stanley Hospital /ID# 240136

    Murdoch, Western Australia, 6150

  • The Queen Elizabeth Hospital /ID# 234242

    Woodville South, South Australia, 5011

  • Princess Alexandra Hospital /ID# 234243

    Woolloongabba, Queensland, 4102

Other trials in Australia

Israel6 sites

  • The Edith Wolfson Medical Center /ID# 234042

    Ashkelon, Southern District, 5822000

  • Soroka University Medical Center /ID# 233458

    Beersheba, Southern District, 8410101

  • Shaare Zedek Medical Center /ID# 233460

    Jerusalem, Jerusalem, 91031

  • Hadassah Medical Center-Hebrew University /ID# 233518

    Jerusalem, Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 233457

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 238525

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

United Kingdom6 sites

  • Royal Devon University Healthcare NHS Foundation Trust /ID# 234194

    Exeter, Devon, EX2 5DW

  • NHS Greater Glasgow and Clyde /ID# 234186

    Glasgow, Scotland, G12 0XH

  • Barts Health NHS Trust /ID# 234188

    London, London, City of, E1 2ES

  • Guys and St Thomas NHS Foundation Trust /ID# 234191

    London, London, City of, SE1 9RT

  • University Hospital Southampton NHS Foundation Trust /ID# 238960

    Southampton, Hampshire, SO16 6YD

  • St George's University Hospitals NHS Foundation Trust /ID# 234193

    Tooting, SW17 0QT

Other trials in United Kingdom

Belgium5 sites

  • UZ Gent /ID# 246877

    Ghent, Oost-Vlaanderen, 9000

  • AZ Maria Middelares /ID# 246880

    Ghent, 9000

  • CHU de Liege /ID# 232436

    Liège, 4000

  • AZ-Delta /ID# 232437

    Roeselare, West-Vlaanderen, 8800

  • UCL Saint-Luc /ID# 232435

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Bulgaria5 sites

  • UMHAT Kaspela /ID# 232468

    Plovdiv, 4001

  • Second MHAT Sofia /ID# 250706

    Sofia, 1202

  • UMHAT Sveti Ivan Rilski /ID# 233522

    Sofia, 1431

  • UMHAT Tsaritsa Joanna - ISUL /ID# 234135

    Sofia, 1527

  • Acibadem City Clinic University Hospital EOOD /ID# 240003

    Sofia, 1784

Other trials in Bulgaria

Czechia4 sites

  • Hepato-Gastroenterologie HK, s.r.o. /ID# 239965

    Hradec Králové, 500 12

  • ARTROSCAN s.r.o. /ID# 239882

    Ostrava, 722 00

  • Nemocnice Horovice - NH Hospital a.s /ID# 233915

    Prague, 155 00

  • Ustredni Vojenska Nemocnice - Vojenska fakultni nemocnice Praha /ID# 238486

    Prague, 162 00

Other trials in Czechia

France4 sites

  • CHU Montpellier - Hôpital Saint Eloi /ID# 241136

    Montpellier, Herault, 34295

  • AP-HP - Hopital Saint-Louis /ID# 234227

    Paris, 75010

  • CHU de SAINT ETIENNE - Hopital Nord /ID# 234225

    Saint Priest EN Jarez, Pays de la Loire Region, 42270

  • CHRU Nancy - Hopitaux de Brabois /ID# 234224

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500

Other trials in France

Greece4 sites

  • General Hospital of Athens Ippokratio /ID# 231655

    Athens, Attica, 11527

  • General Hospital of Chest Diseases of Athens SOTIRIA /ID# 231660

    Athens, Attica, 11527

  • University General Hospital of Heraklion PA.G.N.I /ID# 231657

    Heraklion, Crete, 71500

  • General Hospital of Nikaia-Piraeus "Agios Panteleimon" /ID# 231659

    Pireaus, 18454

Other trials in Greece

Italy4 sites

  • Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 233387

    Bari, 70124

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 233382

    Milan, 20122

  • ASST Rhodense/Presidio Ospedaliero di Rho /ID# 233386

    Rho, Milano, 20017

  • Policlinico Agostino Gemelli /ID# 233380

    Rome, Roma, 00168

Other trials in Italy

Poland4 sites

  • Endoskopia Sp. z o.o. /ID# 249906

    Sopot, Pomeranian Voivodeship, 81-756

  • WIP Warsaw IBD Point Profesor Kierkus /ID# 233533

    Warsaw, Masovian Voivodeship, 00-728

  • Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 238653

    Warsaw, Masovian Voivodeship, 02-507

  • Planetmed Sp. z o.o. /ID# 238447

    Wroclaw, Lower Silesian Voivodeship, 52-210

Other trials in Poland

Spain4 sites

  • Hospital Santa Creu i Sant Pau /ID# 232301

    Barcelona, 08041

  • Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 232299

    Ferrol, A Coruna, 15405

  • Hospital Universitario La Paz /ID# 232300

    Madrid, 28046

  • Hospital Clinico Universitario de Valencia /ID# 234103

    Valencia, 46010

Other trials in Spain

Austria3 sites

  • Medizinische Universitaet Innsbruck /ID# 234217

    Innsbruck, Tyrol, 6020

  • Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 234069

    Salzburg, 5020

  • Medizinische Universitaet Wien /ID# 234218

    Vienna, State of Vienna, 1090

Other trials in Austria

New Zealand3 sites

  • Hutt Hospital /ID# 238327

    Lower Hutt, 5010

  • Wellington Regional Hospital /ID# 238326

    Newtown, Wellington Region, 6021

  • Dunedin Hospital /ID# 238325

    Otago, Otago, 9016

Other trials in New Zealand

Slovakia3 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 232373

    Banská Bystrica, 975 17

  • ENDOMED s.r.o. /ID# 241855

    Košice, 040 01

  • KM Management, spol. s.r.o. /ID# 241849

    Nitra, 949 01

Other trials in Slovakia

South Korea3 sites

  • The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 233700

    Daejeon, 34943

  • Asan Medical Center /ID# 233701

    Seoul, 05505

  • Samsung Medical Center /ID# 233698

    Seoul, 06351

Other trials in South Korea

Taiwan3 sites

  • China Medical University Hospital /ID# 234132

    Taichung, 40447

  • Taichung Veterans General Hospital /ID# 234131

    Taichung, 40705

  • National Taiwan University Hospital /ID# 234134

    Taipei, 100

Other trials in Taiwan

Netherlands2 sites

  • Academisch Medisch Centrum /ID# 232123

    Amsterdam, 1105 AZ

  • Radboud Universitair Medisch Centrum /ID# 241292

    Nijmegen, Gelderland, 6525 GA

Other trials in Netherlands

Portugal2 sites

  • 2CA-Braga, Hospital de Braga /ID# 249049

    Braga, 4710-243

  • Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249047

    Guimarães, Braga District, 4835-044

Other trials in Portugal

Hungary1 site

  • Clinfan Szolgaltato Kft. /ID# 249662

    Szekszárd, 7100

Other trials in Hungary

Puerto Rico1 site

  • Mindful Medical Research /ID# 249609

    San Juan, 00918-3756

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Crohn's Disease (CD): AIM-CD

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide.

Read more

The study is comprised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period.

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. 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.

Conditions
Crohn's Disease
Being tested
ABBV-154, Placebo
Keywords
Crohn's Disease, ABBV-154
Medical subject headings
Crohn Disease

What participants receive

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

  • ABBV-154Drug

    Intravenous (IV) Infusion; Subcutaneous Injection

  • PlaceboDrug

    Intravenous (IV) infusion; Subcutaneous Injection

  • ABBV-154Drug

    Subcutaneous Injection

  • PlaceboDrug

    Subcutaneous Injection

Study groups in NCT05068284
Study groupRoleWhat they receive
Induction Phase: ABBV-154 Randomized Dose AExperimentalVarying doses of ABBV-154 as described in the protocol.
Receives: Drug: ABBV-154
Induction Phase: ABBV-154 Randomized Dose BExperimentalVarying doses of ABBV-154 as described in the protocol.
Receives: Drug: ABBV-154
Induction Phase: ABBV-154 Randomized Dose CExperimentalVarying doses of ABBV-154 as described in the protocol.
Receives: Drug: ABBV-154
Induction Phase: ABBV-154 Randomized Dose DExperimentalVarying doses of ABBV-154 as described in the protocol.
Receives: Drug: ABBV-154; Drug: Placebo
Induction Phase: Randomized PlaceboPlacebo comparatorFixed dose placebo as described in the protocol.
Receives: Drug: Placebo
Re-Induction Phase: ABBV-154 Randomized Dose AExperimentalVarying doses of ABBV-154 as described in the protocol.
Receives: Drug: ABBV-154
Re-Induction Phase: ABBV-154 Randomized Dose BExperimentalVarying doses of ABBV-154 as described in the protocol.
Receives: Drug: ABBV-154
Maintenance Phase: ABBV-154 Randomized Dose AExperimentalFixed dose ABBV-154 every other week.
Receives: Drug: ABBV-154
Maintenance Phase: ABBV-154 Randomized Dose BExperimentalFixed dose ABBV-154 every other week.
Receives: Drug: ABBV-154
Maintenance Phase: Randomized PlaceboPlacebo comparatorFixed dose placebo every other week.
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD)

    The 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). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 (worst) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.

    Measured: Baseline to Week 12

Secondary outcomes (5)

  1. Percentage of Participants Achieving Clinical Remission Per Crohn's Disease Activity Index (CDAI)

    The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Clinical remission is defined as CDAI < 150.

    Measured: Induction Period Week 12

  2. Percentage of Participants Achieving Clinical Remission Per Average Daily Liquid or Very Soft Stool Frequency (SF) and Average Daily Abdominal Pain (AP) Score (SF/AP)

    Clinical remission is defined as average daily liquid or very soft stool SF <= 2.8 and not worse than Baseline and average daily AP score <= 1 and not worse than Baseline.

    Measured: Induction Period Week 12

  3. Percentage of Participants Achieving Endoscopic Response Per SES-CD

    The 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 40 in the Maintenance Period

  4. Percentage of Participants Achieving Clinical Remission Per CDAI

    The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Clinical remission is defined as CDAI < 150.

    Measured: Week 40 in the Maintenance Period

  5. Percentage of Participants Achieving Clinical Remission Per SF/AP

    Clinical remission is defined as average daily liquid or very soft SF <= 2.8 and not worse than Baseline and average daily AP score <= 1 and not worse than Baseline.

    Measured: Week 40 in the Maintenance Period

Timeline

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

  1. First posted5 Oct 2021
  2. Study start31 Jan 2022
  3. Primary completion20 Jul 2023
  4. Study completion20 Jul 2023

Why it stopped: Strategic considerations

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05068284
Sponsor's protocol ID
M20-371
Other IDs
2021-002869-18
Acronym
AIM-CD
Status last verified
Sep 2024
First submitted
27 Sep 2021
Last updated
3 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-154 in people with Crohn's Disease, run by AbbVie at 166 sites in 24 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Japan, Germany, Canada, Australia and 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Achieving Endoscopic Response Per Simple Endoscopic Score for Crohn's Disease (SES-CD) (time frame: Baseline to Week 12). 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 NCT05068284.

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 3 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in