A Phase 3 interventional study of Placebo and Upadacitinib in Ulcerative Colitis (UC), sponsored by AbbVie. Completed at 379 sites in 44 countries. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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).
Study M14-675 consists of 2 parts, Part 1 and Part 2. Part 1 is a randomized, double-blind, placebo-controlled 8-week induction period. Part 2 is an open-label, 8-week extended treatment period for participants who did not achieve clinical response at Week 8 in Part 1.
Eligible participants are randomized in a 2:1 ratio to one of the two treatment groups (upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization is stratified by biologic inadequate responder (bio-IR) status (bio-IR vs non-bio-IR), corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization is further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR, the randomization is further stratified by previous biologic use (yes or no).
Participants who achieve clinical response defined by Adapted Mayo Score at Week 8 or Week 16 and do not meet any study discontinuation criteria are eligible to enroll into Study M14-234 Substudy 3 (NCT02819635; 52-week maintenance study) or Study M14-533 Cohort 1 (NCT03006068; long-term follow-up study).
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 522 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Note: Adolescent participants at the age of 16 or 17 years old must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.
Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above.
Exclusion Criteria:
Participants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
Drug: Upadacitinib
Participants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
Drug: Placebo · Drug: Upadacitinib
Tablet for oral administration
Tablet for oral administration
Also known as: ABT-494, RINVOQ®
Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score 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 remission is defined as an Adapted Mayo score ≤ 2, with SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1.
Time frame: Week 8
Percentage of Participants With Endoscopic Improvement 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).
Time frame: Week 8
Percentage of Participants With Endoscopic Remission 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).
Time frame: Week 8
Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score 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 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 defined as a decrease in Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
Time frame: Week 8
Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at 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 or an absolute RBS ≤ 1.
Time frame: Week 2
Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at 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; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Time frame: Week 8
Percentage of Participants Who Reported No Bowel Urgency at Week 8
Bowel urgency was assessed by participants in a subject diary completed once a day.
Time frame: Week 8
Percentage of Participants Who Reported No Abdominal Pain at Week 8
Abdominal pain was assessed by participants in a subject diary completed once a day.
Time frame: Week 8
Percentage of Participants Who Achieved Histologic Improvement at 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.
Time frame: Week 8
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at 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.
Time frame: Baseline (Week 0) to Week 8
Percentage of Participants Who Achieved Mucosal Healing at 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 and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
Time frame: Week 8
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at 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.
Time frame: Baseline (Week 0) to Week 8
This study included a Screening Period of up to 5 weeks, Part 1, and Part 2. Part 1 was a randomized, double-blind, placebo-controlled 8-week induction period. Part 2 was an open-label, 8-week extended treatment period for participants who were clinical non-responders in Part 1. Participants with moderately to severely active ulcerative colitis (UC) were randomized at 204 sites in 41 countries.
| Milestone | Part 1: Upadacitinib 45 mg | Part 1: Placebo | Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg | Part 2: Placebo / Upadacitinib 45 mg |
|---|---|---|---|---|
| Started | 345 | 177 | 0 | 0 |
| Received treatment | 344 | 177 | 0 | 0 |
| Completed | 334 | 164 | 0 | 0 |
| Not completed | 11 | 13 | 0 | 0 |
| Withdrew: Adverse event | 5 | 6 | 0 | 0 |
| Withdrew: Withdrawal by subject | 6 | 4 | 0 | 0 |
| Withdrew: Other | 0 | 3 | 0 | 0 |
| Milestone | Part 1: Upadacitinib 45 mg | Part 1: Placebo | Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg | Part 2: Placebo / Upadacitinib 45 mg |
|---|---|---|---|---|
| Started | 0 | 0 | 68 | 116 |
| Completed | 0 | 0 | 65 | 111 |
| Not completed | 0 | 0 | 3 | 5 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 2 |
| Withdrew: Other | 0 | 0 | 1 | 2 |
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, with SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1.
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 | 33.5 (28.5 to 38.5) | 4.1 (1.1 to 7.1) |
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).
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants With Endoscopic Improvement at Week 8 | 44.0 (38.8 to 49.3) | 8.3 (4.1 to 12.5) |
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).
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants With Endoscopic Remission at Week 8 | 18.2 (14.1 to 22.3) | 1.7 (0.0 to 3.7) |
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 defined as a decrease in Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8 | 74.5 (69.9 to 79.1) | 25.4 (18.9 to 31.8) |
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 or an absolute RBS ≤ 1.
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2 | 63.3 (58.2 to 68.5) | 25.9 (19.4 to 32.4) |
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; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8 | 36.7 (31.6 to 41.8) | 5.9 (2.3 to 9.4) |
Bowel urgency was assessed by participants in a subject diary completed once a day.
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants Who Reported No Bowel Urgency at Week 8 | 53.7 (48.4 to 59.0) | 25.9 (19.4 to 32.4) |
Abdominal pain was assessed by participants in a subject diary completed once a day.
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants Who Reported No Abdominal Pain at Week 8 | 53.7 (48.4 to 59.0) | 24.1 (17.8 to 30.5) |
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.
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved Histologic Improvement at Week 8 | 62.2 (57.0 to 67.3) | 24.5 (18.0 to 30.9) |
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.
| units on a scale | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8 | 52.2 (48.57 to 55.92) | 21.1 (15.98 to 26.17) |
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.
| percentage of participants | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Percentage of Participants Who Achieved Mucosal Healing at Week 8 | 13.5 (9.9 to 17.1) | 1.7 (0.0 to 3.7) |
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.
| units on a scale | Upadacitinib 45 mg | Placebo |
|---|---|---|
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8 | 9.4 (8.38 to 10.48) | 3.5 (2.02 to 4.92) |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Upadacitinib 45 mg | 0/344 (0%) | 11/344 (3.2%) | 32/344 (9.3%) |
| Part 1: Placebo | 0/177 (0%) | 8/177 (4.5%) | 11/177 (6.2%) |
| Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg | 0/68 (0%) | 1/68 (1.5%) | 10/68 (14.7%) |
| Part 2: Placebo / Upadacitinib 45 mg | 0/116 (0%) | 4/116 (3.4%) | 17/116 (14.7%) |
| Event | Part 1: Upadacitinib 45 mg | Part 1: Placebo | Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg | Part 2: Placebo / Upadacitinib 45 mg |
|---|---|---|---|---|
| COLITIS ULCERATIVEGastrointestinal disorders | 4/344 | 3/177 | 1/68 | 1/116 |
| ABDOMINAL DISCOMFORTGastrointestinal disorders | 0/344 | 0/177 | 0/68 | 1/116 |
| ABDOMINAL PAIN LOWERGastrointestinal disorders | 0/344 | 0/177 | 0/68 | 1/116 |
| COVID-19 PNEUMONIAInfections and infestations | 1/344 | 0/177 | 0/68 | 1/116 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASERespiratory, thoracic and mediastinal disorders | 0/344 | 0/177 | 0/68 | 1/116 |
| ANAEMIABlood and lymphatic system disorders | 1/344 | 1/177 | 0/68 | 0/116 |
| COLITISGastrointestinal disorders | 0/344 | 1/177 | 0/68 | 0/116 |
| LARGE INTESTINE PERFORATIONGastrointestinal disorders | 0/344 | 1/177 | 0/68 | 0/116 |
| ENTEROCOCCAL INFECTIONInfections and infestations | 0/344 | 1/177 | 0/68 | 0/116 |
| ESCHERICHIA INFECTIONInfections and infestations | 0/344 | 1/177 | 0/68 | 0/116 |
| Event | Part 1: Upadacitinib 45 mg | Part 1: Placebo | Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg | Part 2: Placebo / Upadacitinib 45 mg |
|---|---|---|---|---|
| ACNESkin and subcutaneous tissue disorders | 24/344 | 3/177 | 0/68 | 6/116 |
| ANAEMIABlood and lymphatic system disorders | 0/344 | 0/177 | 4/68 | 3/116 |
| PYREXIAGeneral disorders | 0/344 | 0/177 | 4/68 | 4/116 |
| BLOOD CREATINE PHOSPHOKINASE INCREASEDInvestigations | 0/344 | 0/177 | 4/68 | 5/116 |
| HEADACHENervous system disorders | 8/344 | 9/177 | 0/68 | 0/116 |
| Age, Continuous(years) | Upadacitinib 45 mg | Placebo | Total |
|---|---|---|---|
| Mean | 42.2 ± 14.73 | 42.2 ± 14.44 | 42.2 ± 14.62 |
| Age, Customized(Participants) | Upadacitinib 45 mg | Placebo | Total |
|---|---|---|---|
| < 18 years | 6 | 3 | 9 |
| ≥ 18 years to < 40 years | 160 | 81 | 241 |
| ≥ 40 years to < 65 years | 146 | 79 | 225 |
| ≥ 65 years | 33 | 14 | 47 |
| Sex: Female, Male(Participants) | Upadacitinib 45 mg | Placebo | Total |
|---|---|---|---|
| Female | 129 | 67 | 196 |
| Male | 216 | 110 | 326 |
| Ethnicity (NIH/OMB)(Participants) | Upadacitinib 45 mg | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 26 | 16 | 42 |
| Not Hispanic or Latino | 319 | 161 | 480 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Upadacitinib 45 mg | Placebo | Total |
|---|---|---|---|
| White | 238 | 127 | 365 |
| Black or African American | 11 | 6 | 17 |
| Asian | 94 | 41 | 135 |
| American Indian or Alaska Native | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Multiple | 2 | 1 | 3 |
| Biologic-inadequate Responder (Bio-IR) Status(Participants) | Upadacitinib 45 mg | Placebo | Total |
|---|---|---|---|
| Bio-IR | 175 | 91 | 266 |
| Non-Bio-IR | 170 | 86 | 256 |
| Baseline Corticosteroid Use(Participants) | Upadacitinib 45 mg | Placebo | Total |
|---|---|---|---|
| Yes | 123 | 75 | 198 |
| No | 222 | 102 | 324 |
| Adapted Mayo Score Strata(Participants) | Upadacitinib 45 mg | Placebo | Total |
|---|---|---|---|
| ≤ 7 | 205 | 104 | 309 |
| > 7 | 138 | 73 | 211 |
| Missing | 2 | 0 | 2 |
7 further baseline measures are reported on the registry.
Showing the first 100 of 379 sites across 44 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting information: Study protocol, Sap, Csr
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