Trial · NCT02819635
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
NCT02819635, Phase 2, Phase 3, Completed, AbbVie; results first posted 2022-06-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC). Trials, record NCT02819635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02819635
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
- NCT number
- NCT02819635
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,302 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Ulcerative Colitis (UC)
- Interventions
- Placebo, Upadacitinib
- First posted
- 2016-06-30
- Last updated
- 2022-06-30
- Other registries' IDs
- eudract:2016-000641-31
- Results first posted
- 2022-06-30
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | At Week 8 | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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. For Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1. |
| Primary | Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | At Week 8 | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal) 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed) 3. 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. For Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2. |
| Primary | Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52 | At Week 52 | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. 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. For Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2. |
| Secondary | Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8 | At Week 8 | Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). |
| Secondary | Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8 | At Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1. |
| Secondary | Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8 | At Week 8 | The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. 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 is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1). |
| Secondary | Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2 | At Week 2 | The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease. Clinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. |
| Secondary | Substudy 1: Change in Full Mayo Score From Baseline to Week 8 | Baseline (Week 0), Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1. |
| Secondary | Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8 | At Week 8 | Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). |
| Secondary | Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8 | At Week 8 | The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | At Week 8 | SS1 main population (ITT1A): those randomized to ≥1 dose of study drug during the initial part of SS1. Non-responder imputation (NRI) was used to impute missing values. | percentage of participants | NUMBER |
| PRIMARY | Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | At Week 8 | SS2, Part 1 population (ITT1): all randomized participants in the 8-week double-blind induction period who received ≥1 dose of study drug. NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used for SS2, with participants analyzed according to treatment groups to which they were randomized. | percentage of participants | NUMBER |
| PRIMARY | Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52 | At Week 52 | Substudy 3 ITT\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2 | At Week 2 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Change in Full Mayo Score From Baseline to Week 8 | Baseline (Week 0), Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Last observation carried forward (LOCF) was used for missing data. | units on a scale | MEAN |
| SECONDARY | Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
| SECONDARY | Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8 | At Week 8 | The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population. | percentage of participants | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group103
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | SS1: Placebo | 0 | percentage of participants | ||
| Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | SS1: Upadacitinib 7.5 mg | 8.5 | percentage of participants | ||
| Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | SS1: Upadacitinib 15 mg | 14.3 | percentage of participants | ||
| Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | SS1: Upadacitinib 30 mg | 13.5 | percentage of participants | ||
| Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | SS1: Upadacitinib 45 mg | 21.4 | percentage of participants | ||
| Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | SS2: Placebo | 4.8 | percentage of participants | ||
| Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | SS2: Upadacitinib 45 mg | 26.1 | percentage of participants | ||
| Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52 | SS3: Placebo | 12.1 | 95% Confidence Interval 6.9 to 17.4 | percentage of participants | |
| Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52 | SS3: UPA 15 mg | 42.3 | 95% Confidence Interval 34.3 to 50.3 | percentage of participants | |
| Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52 | SS3: UPA 30 mg | 51.7 | 95% Confidence Interval 43.6 to 59.8 | percentage of participants |
1 to 10 of 103Source ClinicalTrials.gov
See all 103 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS1: Placebo | 46 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS1: Upadacitinib 7.5 mg | 47 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS1: Upadacitinib 15 mg | 49 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS1: Upadacitinib 30 mg | 117 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS1: Upadacitinib 45 mg | 123 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS2: Placebo/Upadacitinib 45 mg | 155 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS2: Upadacitinib 45 mg/Upadacitinib 45 mg | 319 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS3: M14-675 Clinical Responders | 446 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS3: Placebo | 0 | |
| Substudy 1 and Substudy 2, Part 1 | STARTED | SS3: UPA 7.5 mg | 0 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events1,924
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | SS1: Placebo | 3 | 46 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS1: Upadacitinib 7.5 mg | 0 | 47 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS1: Upadacitinib 15 mg | 3 | 49 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS1: Upadacitinib 30 mg | 4 | 117 | 4 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS1: Upadacitinib 45 mg | 1 | 123 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS2: Placebo | 9 | 155 | 9 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS2: Upadacitinib 45 mg | 8 | 319 | 8 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS2: Placebo/Upadacitinib 45 mg | 5 | 85 | 5 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS2: Upadacitinib 45 mg/Upadacitinib 45 mg | 1 | 59 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | SS3: Placebo | 20 | 385 | 24 |
1 to 10 of 1,924Source ClinicalTrials.gov
See all 1,924 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SS1: Placebo | 0 | 46 |
| Total, all-cause mortality | SS1: Upadacitinib 7.5 mg | 0 | 47 |
| Total, all-cause mortality | SS1: Upadacitinib 15 mg | 0 | 49 |
| Total, all-cause mortality | SS1: Upadacitinib 30 mg | 0 | 117 |
| Total, all-cause mortality | SS1: Upadacitinib 45 mg | 0 | 123 |
| Total, all-cause mortality | SS2: Placebo | 0 | 155 |
| Total, all-cause mortality | SS2: Upadacitinib 45 mg | 0 | 319 |
| Total, all-cause mortality | SS2: Placebo/Upadacitinib 45 mg | 0 | 85 |
| Total, all-cause mortality | SS2: Upadacitinib 45 mg/Upadacitinib 45 mg | 0 | 59 |
| Total, all-cause mortality | SS3: Placebo | 0 | 385 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers14
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02819635
GET https://conductscience.org/api/trials/v1/NCT02819635/registered?page=2