Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501263-41-00 | Other Identifier | EU CT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed.
ABBV-668 is an investigational drug being developed for the treatment of moderate to severe UC. Approximately 40 adult participants diagnosed with UC will be enrolled in approximately 30 sites globally.
Participants will receive oral capsules of ABBV-668 twice daily for 16 weeks and will undergo a 30 day follow-up period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-668 | Experimental | Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-668 | Drug | Oral Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Endoscopic Improvement | Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes. | Week 8 |
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | From the time of first study drug administration until 30 days after the last dose of study drug (Up to approximately 20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission per Adapted Mayo Score was defined as SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1. Data are reported for the percentage of participants achieving clinical remission per adapted Mayo score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastro SB /ID# 249271 | Chula Vista | California | 91910-5619 | United States | ||
| Ctr for Advanced Gastroenterol /ID# 249226 |
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.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ABBV-668 | Participants received ABBV-668 twice daily for 16 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2023 | Dec 8, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline, Week 8 |
| Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response per Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per adapted Mayo score. | Baseline, Week 8 |
| Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 where higher scores represent more severe disease. Clinical response per Partial Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 1 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per partial adapted Mayo score. | Baseline, Week 8 |
| Percentage of Participants Achieving Endoscopic Remission | Endoscopic remission was defined as Mayo endoscopic subscore of 0. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes. | Week 8 |
| Maitland |
| Florida |
| 32751-6108 |
| United States |
| Atlantic Medical Research /ID# 249213 | Margate | Florida | 33063-5737 | United States |
| Endoscopic Research, Inc. /ID# 249202 | Orlando | Florida | 32803 | United States |
| Gastroenterology Associates of Central Georgia, LLC /ID# 249278 | Macon | Georgia | 31201 | United States |
| NYU Langone Long Island Clinical Research Associates /ID# 250075 | Lake Success | New York | 11042 | United States |
| Columbia University Medical Center /ID# 250189 | New York | New York | 10032-3729 | United States |
| Lenox Hill Hospital /ID# 250008 | New York | New York | 10075 | United States |
| Atrium Health /ID# 249273 | Charlotte | North Carolina | 28204-2963 | United States |
| Options Health Research, LLC /ID# 249216 | Tulsa | Oklahoma | 74104 | United States |
| University of Pennsylvania /ID# 250012 | Philadelphia | Pennsylvania | 19104-5502 | United States |
| Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079 | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh MC /ID# 250071 | Pittsburgh | Pennsylvania | 15260 | United States |
| Gastroenterology Associates, P.A. of Greenville /ID# 249217 | Greenville | South Carolina | 29607 | United States |
| Quality Medical Research /ID# 251125 | Nashville | Tennessee | 37211 | United States |
| Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208 | Garland | Texas | 75044 | United States |
| Baylor College of Medicine /ID# 249203 | Houston | Texas | 77030 | United States |
| Southern Star Research Institute, LLC /ID# 249212 | San Antonio | Texas | 78229-5390 | United States |
| UZ Gent /ID# 248605 | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| Vitaz /Id# 248607 | Sint-Niklaas | Oost-Vlaanderen | 9100 | Belgium |
| Universitair Ziekenhuis Leuven /ID# 248598 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Groupe Sante CHC - Clinique du MontLegia /ID# 248928 | Liège | 4000 | Belgium |
| CHU Montpellier - Hopital Saint Eloi /ID# 251876 | Montpellier | Herault | 34295 | France |
| CHU Grenoble - Hopital Michallon /ID# 252108 | La Tronche | Isere | 38700 | France |
| Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875 | St-Priest-en-Jarez | Pays de la Loire Region | 42270 | France |
| Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357 | Neuilly-sur-Seine | ÃŽle-de-France Region | 92200 | France |
| Gastromed Sp. z o.o /ID# 255664 | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663 | Warsaw | Masovian Voivodeship | 00-728 | Poland |
| Endoskopia Sp. z o.o. /ID# 255667 | Sopot | Pomeranian Voivodeship | 81-756 | Poland |
| H-T Centrum Medyczne Endoterapia /ID# 255666 | Tychy | Silesian Voivodeship | 43-100 | Poland |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Intent-to-Treat (ITT) population consisted of all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABBV-668 | Participants received ABBV-668 twice daily for 16 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Endoscopic Improvement | Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes. | The ITT Population consisted of all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | The Safety Population consisted of all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From the time of first study drug administration until 30 days after the last dose of study drug (Up to approximately 20 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:
The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission per Adapted Mayo Score was defined as SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1. Data are reported for the percentage of participants achieving clinical remission per adapted Mayo score. | The ITT Population consisted of all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response per Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per adapted Mayo score. | The ITT Population consisted of all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 where higher scores represent more severe disease. Clinical response per Partial Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 1 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per partial adapted Mayo score. | The ITT Population consisted of all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Endoscopic Remission | Endoscopic remission was defined as Mayo endoscopic subscore of 0. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes. | The ITT Population consisted of all participants who received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
|
All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days.
All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABBV-668 | Participants received ABBV-668 twice daily for 16 weeks. | 0 | 30 | 4 | 30 | 12 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ANOGENITAL DYSPLASIA | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2024 | Dec 8, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|