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.
Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8Primary· 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 remission is defined as an Adapted Mayo score ≤ 2,
Group
Value
95% CI
Upadacitinib 45 mg
33.5
28.5 – 38.5
Placebo
4.1
1.1 – 7.1
Percentage of Participants With Endoscopic Improvement at Week 8Secondary· 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
Upadacitinib 45 mg
44.0
38.8 – 49.3
Placebo
8.3
4.1 – 12.5
Percentage of Participants With Endoscopic Remission at Week 8Secondary· 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
Upadacitinib 45 mg
18.2
14.1 – 22.3
Placebo
1.7
0.0 – 3.7
Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8Secondary· 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 with spontaneous bleeding, ulceration).
The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease.
Clinical response per the Adapted Mayo Score is define
Group
Value
95% CI
Upadacitinib 45 mg
74.5
69.9 – 79.1
Placebo
25.4
18.9 – 31.8
Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2Secondary· Week 2
The Partial Adapted 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 Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease.
Clinical response per Partial Adapted Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1
Group
Value
95% CI
Upadacitinib 45 mg
63.3
58.2 – 68.5
Placebo
25.9
19.4 – 32.4
Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8Secondary· Week 8
Histologic endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.
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; G
Group
Value
95% CI
Upadacitinib 45 mg
36.7
31.6 – 41.8
Placebo
5.9
2.3 – 9.4
Percentage of Participants Who Reported No Bowel Urgency at Week 8Secondary· Week 8
Bowel urgency was assessed by participants in a subject diary completed once a day.
Group
Value
95% CI
Upadacitinib 45 mg
53.7
48.4 – 59.0
Placebo
25.9
19.4 – 32.4
Percentage of Participants Who Reported No Abdominal Pain at Week 8Secondary· Week 8
Abdominal pain was assessed by participants in a subject diary completed once a day.
Group
Value
95% CI
Upadacitinib 45 mg
53.7
48.4 – 59.0
Placebo
24.1
17.8 – 30.5
Percentage of Participants Who Achieved Histologic Improvement at Week 8Secondary· Week 8
Histologic improvement is defined as a decrease from Baseline in Geboes score. 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.
Group
Value
95% CI
Upadacitinib 45 mg
62.2
57.0 – 67.3
Placebo
24.5
18.0 – 30.9
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8Secondary· Baseline (Week 0) to Week 8
The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
Group
Value
95% CI
Upadacitinib 45 mg
52.2
48.57 – 55.92
Placebo
21.1
15.98 – 26.17
Percentage of Participants Who Achieved Mucosal Healing at Week 8Secondary· Week 8
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 a
Group
Value
95% CI
Upadacitinib 45 mg
13.5
9.9 – 17.1
Placebo
1.7
0.0 – 3.7
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8Secondary· Baseline (Week 0) to Week 8
The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.
Group
Value
95% CI
Upadacitinib 45 mg
9.4
8.38 – 10.48
Placebo
3.5
2.02 – 4.92
Adverse events — posted to ClinicalTrials.gov
Time frame: Part 1: From first dose of study drug up to 30 days after the last dose (up to 12 weeks) or until first dose of study drug in Part 2 or first dose of study drug in M14-234 (NCT02819635; maintenance study) or M14-533 (NCT03006068; long term extension). Part 2: From the first dose of study drug in Part 2 up to 30 days after last dose (up to 12 weeks) or until first dose of study drug in M14-234 (maintenance study) or the first dose date of study drug in M14-533 (long-term extension study)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07502339 — Upadacitinib in Patients Hospitalized With Acute Severe Ulcerative Colitis
· Phase 4
· not yet recruiting
NCT07492251 — Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Ran
· Phase 2
· not yet recruiting
NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
· not yet recruiting
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
Other recruiting trials for Ulcerative Colitis (UC)
Currently open trials in the same condition.
NCT07335055 — A Study for HSK47388 in Participants With Ulcerative Colitis
· Phase 2
· recruiting
NCT07271069 — Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
· recruiting
NCT07245394 — Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)
· recruiting
NCT07237516 — Zymfentra (Infliximab-dyyb) REal World Cohort STudy
· recruiting
NCT07350577 — Evaluate the Safety, Tolerability, PK and PD of SAD of Intravenously Adminsterted ALTB-268 in Healthy Participants
· Phase 1
· recruiting
Other AbbVie trials
Trials by the same sponsor.
NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants
· Phase 1
· completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W
· Phase 3
· withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult
· Phase 1
· completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China
· completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled
· Phase 1
· completed
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: 2 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03653026.