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)
CompletedPhase 2, PHASE3Results postedLast updated 30 June 2022
What this trial tests
Phase 2, PHASE3 trial testing Placebo in Ulcerative Colitis (UC) in 1,302 participants. Completed in 13 December 2021.
Adults 16 to 75, any sex, with Ulcerative Colitis (UC). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8Primary· 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 o
Group
Value
95% CI
SS1: Placebo
0
SS1: Upadacitinib 7.5 mg
8.5
SS1: Upadacitinib 15 mg
14.3
SS1: Upadacitinib 30 mg
13.5
SS1: Upadacitinib 45 mg
21.4
Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8Primary· 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 no
Group
Value
95% CI
SS2: Placebo
4.8
SS2: Upadacitinib 45 mg
26.1
Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52Primary· 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
Group
Value
95% CI
SS3: Placebo
12.1
6.9 – 17.4
SS3: UPA 15 mg
42.3
34.3 – 50.3
SS3: UPA 30 mg
51.7
43.6 – 59.8
Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8Secondary· 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).
Group
Value
95% CI
SS1: Placebo
2.2
SS1: Upadacitinib 7.5 mg
14.9
SS1: Upadacitinib 15 mg
30.6
SS1: Upadacitinib 30 mg
26.9
SS1: Upadacitinib 45 mg
35.7
Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8Secondary· 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.
Group
Value
95% CI
SS1: Placebo
0
SS1: Upadacitinib 7.5 mg
10.6
SS1: Upadacitinib 15 mg
10.2
SS1: Upadacitinib 30 mg
11.5
SS1: Upadacitinib 45 mg
19.6
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8Secondary· 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 t
Group
Value
95% CI
SS1: Placebo
13.0
SS1: Upadacitinib 7.5 mg
29.8
SS1: Upadacitinib 15 mg
49.0
SS1: Upadacitinib 30 mg
46.2
SS1: Upadacitinib 45 mg
55.4
Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2Secondary· 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.
Group
Value
95% CI
SS1: Placebo
17.4
SS1: Upadacitinib 7.5 mg
23.4
SS1: Upadacitinib 15 mg
34.7
SS1: Upadacitinib 30 mg
36.5
SS1: Upadacitinib 45 mg
55.4
Substudy 1: Change in Full Mayo Score From Baseline to Week 8Secondary· 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.
Group
Value
95% CI
SS1: Placebo
-0.741
± 2.3302
SS1: Upadacitinib 7.5 mg
-2.870
± 2.9685
SS1: Upadacitinib 15 mg
-3.589
± 2.4984
SS1: Upadacitinib 30 mg
-4.211
± 3.0886
SS1: Upadacitinib 45 mg
-4.606
± 2.8976
Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8Secondary· 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).
Group
Value
95% CI
SS1: Placebo
0
SS1: Upadacitinib 7.5 mg
6.4
SS1: Upadacitinib 15 mg
4.1
SS1: Upadacitinib 30 mg
9.6
SS1: Upadacitinib 45 mg
17.9
Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8Secondary· 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.
Group
Value
95% CI
SS1: Placebo
6.5
SS1: Upadacitinib 7.5 mg
31.9
SS1: Upadacitinib 15 mg
51.0
SS1: Upadacitinib 30 mg
44.2
SS1: Upadacitinib 45 mg
48.2
Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8Secondary· 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).
Group
Value
95% CI
SS2: Placebo
7.4
3.2 – 11.5
SS2: Upadacitinib 45 mg
36.3
31.0 – 41.7
Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8Secondary· 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).
Group
Value
95% CI
SS2: Placebo
1.3
0.0 – 3.1
SS2: Upadacitinib 45 mg
13.7
9.9 – 17.6
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07502339 — Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis
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NCT07492251 — Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Ran
· Phase 2
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NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
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NCT07546097 — Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（U
· Phase 4
· recruiting
NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response
· Phase 4
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 30 June 2022
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