Trial · NCT03398148
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
NCT03398148, Phase 2, Phase 3, Completed, AbbVie; results first posted 2025-01-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. Trials, record NCT03398148. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03398148
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
- NCT number
- NCT03398148
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 1,558 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Ulcerative Colitis (UC)
- Interventions
- risankizumab IV, placebo for risankizumab, risankizumab SC
- First posted
- 2018-01-12
- Last updated
- 2025-01-16
- Other registries' IDs
- eudract:2016-004677-40
- Results first posted
- 2025-01-16
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Week 12 | 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 Sub-Study 1, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. |
| Primary | Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Week 12 | 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 Sub-Study 2, clinical remission was defined as SFS ≤ 1, and not greater than baseline, RBS of 0, and endoscopic subscore ≤ 1. Evidence of friability during endoscopy in subjects with otherwise "mild" endoscopic activity will confer an endoscopic subscore of 2. |
| Secondary | Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Week 12 | Endoscopic improvement is defined as endoscopy 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 | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Full Mayo Score in Participants With a Full Mayo Score of 6 to 12 at Baseline | Week 12 | 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 | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | Week 12 | 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 per Adapted Mayo Score was defined as decrease from baseline in Adapted Mayo Score ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. |
| Secondary | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | Week 4 | Clinical response per Partial Adapted Mayo Score (without endoscopy). 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 \>= 1 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. |
| Secondary | Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | Week 12 | Endoscopic remission was defined as endoscopy subscore of 0. |
| Secondary | Sub-Study 1: Percentage of Participants With Hospitalization | Through Week 12 | Participants with an event that results in admission to the hospital. |
| Secondary | Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | Week 12 | Mucosal healing defined as endoscopic and histologic remission. Mucosal healing is defined as an endoscopic score of 0 and Geboes score \< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration). 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. |
| Secondary | Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | Baseline Through Week 12 | The US-SQ is a patient questionnaire to assess severity of Ulcerative Colitis (UC) related gastrointestinal symptoms (e.g., frequent bowel movements, abdominal pain, cramping) and non-gastrointestinal symptoms (e.g., joint pain and sleep difficulties). It consists of 17 questions and each question is answered on a scale from can be answered on a scale from 1 (Not at all/ never) to 5 (Very much/Always) with overall symptom score range from 17 to 85. A lower score indicates lower UC severity. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Week 12 | ITT1A includes all randomized subjects who received at least one dose of study drug during Induction Period 1 from Substudy 1.~ITT1B includes all the additional subjects who received at least one dose of risankizumab 1800 mg IV treatment group after 240 subjects were randomized during Induction Period 1 from Substudy 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Week 12 | ITT2 population. | percentage of participants | NUMBER |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Full Mayo Score in Participants With a Full Mayo Score of 6 to 12 at Baseline | Week 12 | No data was collected. | ||
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score | Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score | Week 4 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Endoscopic Remission | Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants With Hospitalization | Through Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Percentage of Participants Achieving Histologic Endoscopic Mucosal Remission (HEMR) | Week 12 | Includes ITT1A and ITT1B populations. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Sub-Study 1: Change in Ulcerative Colitis Symptom Questionnaire (UC-SQ) | Baseline Through Week 12 | Includes ITT1A and ITT1B participants with data available for analysis. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group97
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Substudy 1, Induction Period 1: Double-blind Placebo IV | 1 | Participants | ||
| Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | 7 | Participants | ||
| Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | 6 | Participants | ||
| Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | 6 | Participants | ||
| Sub-Study 1: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | 42 | Participants | ||
| Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Substudy 2, Induction Period 1: Double-blind Placebo IV | 6.2 | 95% Confidence Interval 3.6 to 8.9 | percentage of participants | |
| Sub-Study 2: Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score | Substudy 2, Induction Period 1: Double-blind Risankizumab 1200mg IV | 20.3 | 95% Confidence Interval 17.2 to 23.4 | percentage of participants | |
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Substudy 1, Induction Period 1: Double-blind Placebo IV | 3 | Participants | ||
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | 15 | Participants | ||
| Sub-Study 1: Percentage of Participants Achieving Endoscopic Improvement | Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | 8 | Participants |
1 to 10 of 97Source ClinicalTrials.gov
See all 97 results by groupParticipant flow180
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 1: Double-blind Placebo IV | 60 | |
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | 61 | |
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | 61 | |
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | 58 | |
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 1: Open-label Risankizumab 1800mg IV | 341 | |
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC | 0 | |
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC | 0 | |
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV | 0 | |
| Substudy 1 Period 1 | STARTED | Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo | 0 | |
| Substudy 1 Period 1 | STARTED | Substudy 2, Induction Period 1: Double-blind Placebo IV | 0 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 participant flowAdverse events1,305
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 | Substudy 1, Induction Period 1: Double-blind Placebo IV | 2 | 59 | 2 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | 0 | 62 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | 2 | 61 | 3 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | 1 | 58 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 1, Induction Period 1: Openlabel Risankizumab 1800mg IV | 12 | 341 | 12 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo | 0 | 36 | 0 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV | 1 | 37 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC | 1 | 71 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC | 1 | 71 | 1 |
| other | ANAEMIA | Blood and lymphatic system disorders | Substudy 2, Induction Period 1: Double-blind Placebo IV | 19 | 324 | 21 |
1 to 10 of 1,305Source ClinicalTrials.gov
See all 1,305 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Substudy 1, Induction Period 1: Double-blind Placebo IV | 0 | 59 |
| Total, all-cause mortality | Substudy 1, Induction Period 1: Double-blind Risankizumab 600mg IV | 0 | 62 |
| Total, all-cause mortality | Substudy 1, Induction Period 1: Double-blind Risankizumab 1200mg IV | 0 | 61 |
| Total, all-cause mortality | Substudy 1, Induction Period 1: Double-blind Risankizumab 1800mg IV | 0 | 58 |
| Total, all-cause mortality | Substudy 1, Induction Period 1: Openlabel Risankizumab 1800mg IV | 0 | 341 |
| Total, all-cause mortality | Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV Pbo | 0 | 36 |
| Total, all-cause mortality | Substudy 1, Induction Period 2: Double-blind Risankizumab 1800mg IV | 0 | 37 |
| Total, all-cause mortality | Substudy 1, Induction Period 2: Double-blind Risankizumab 180mg SC | 0 | 71 |
| Total, all-cause mortality | Substudy 1, Induction Period 2: Double-blind Risankizumab 360mg SC | 0 | 71 |
| Total, all-cause mortality | Substudy 2, Induction Period 1: Double-blind Placebo IV | 0 | 324 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers5
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/NCT03398148
GET https://conductscience.org/api/trials/v1/NCT03398148/registered?page=2