Trial Outcomes & Findings for A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT03653026)

Last Updated: 2022-03-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

522 participants

Primary outcome timeframe

Week 8

Results posted on

2022-03-02

Participant Flow

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.

In Part 1 participants were randomized in a 2:1 ratio to upadacitinib or placebo. Randomization was 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, randomization was further stratified by number of prior biologic treatments (≤ 1 or \> 1). Within non-bio-IR, randomization was further stratified by previous biologic use (yes or no).

Participant milestones

Participant milestones
Measure	Part 1: Upadacitinib 45 mg Participants received 45 mg upadacitinib once daily (QD) for 8 weeks.	Part 1: Placebo Participants received placebo matching to upadacitinib once daily for 8 weeks.	Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg Participants initially assigned to upadacitinib who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.	Part 2: Placebo / Upadacitinib 45 mg Participants initially assigned to placebo who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
Part 1: Placebo-controlled Period STARTED	345	177	0	0
Part 1: Placebo-controlled Period Received Treatment	344	177	0	0
Part 1: Placebo-controlled Period COMPLETED	334	164	0	0
Part 1: Placebo-controlled Period NOT COMPLETED	11	13	0	0
Part 2: Open-label Extension STARTED	0	0	68	116
Part 2: Open-label Extension COMPLETED	0	0	65	111
Part 2: Open-label Extension NOT COMPLETED	0	0	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Upadacitinib 45 mg Participants received 45 mg upadacitinib once daily (QD) for 8 weeks.	Part 1: Placebo Participants received placebo matching to upadacitinib once daily for 8 weeks.	Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg Participants initially assigned to upadacitinib who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.	Part 2: Placebo / Upadacitinib 45 mg Participants initially assigned to placebo who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
Part 1: Placebo-controlled Period Adverse Event	5	6	0	0
Part 1: Placebo-controlled Period Withdrawal by Subject	6	4	0	0
Part 1: Placebo-controlled Period Other	0	3	0	0
Part 2: Open-label Extension Adverse Event	0	0	1	1
Part 2: Open-label Extension Withdrawal by Subject	0	0	1	2
Part 2: Open-label Extension Other	0	0	1	2

Baseline Characteristics

Biologic-inadequate responders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Upadacitinib 45 mg n=345 Participants Participants received 45 mg upadacitinib once daily (QD) for 8 weeks.	Placebo n=177 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.	Total n=522 Participants Total of all reporting groups
Age, Continuous	42.2 years STANDARD_DEVIATION 14.73 • n=345 Participants	42.2 years STANDARD_DEVIATION 14.44 • n=177 Participants	42.2 years STANDARD_DEVIATION 14.62 • n=522 Participants
Age, Customized < 18 years	6 Participants n=345 Participants	3 Participants n=177 Participants	9 Participants n=522 Participants
Age, Customized ≥ 18 years to < 40 years	160 Participants n=345 Participants	81 Participants n=177 Participants	241 Participants n=522 Participants
Age, Customized ≥ 40 years to < 65 years	146 Participants n=345 Participants	79 Participants n=177 Participants	225 Participants n=522 Participants
Age, Customized ≥ 65 years	33 Participants n=345 Participants	14 Participants n=177 Participants	47 Participants n=522 Participants
Sex: Female, Male Female	129 Participants n=345 Participants	67 Participants n=177 Participants	196 Participants n=522 Participants
Sex: Female, Male Male	216 Participants n=345 Participants	110 Participants n=177 Participants	326 Participants n=522 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=345 Participants	16 Participants n=177 Participants	42 Participants n=522 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	319 Participants n=345 Participants	161 Participants n=177 Participants	480 Participants n=522 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=345 Participants	0 Participants n=177 Participants	0 Participants n=522 Participants
Race/Ethnicity, Customized White	238 Participants n=345 Participants	127 Participants n=177 Participants	365 Participants n=522 Participants
Race/Ethnicity, Customized Black or African American	11 Participants n=345 Participants	6 Participants n=177 Participants	17 Participants n=522 Participants
Race/Ethnicity, Customized Asian	94 Participants n=345 Participants	41 Participants n=177 Participants	135 Participants n=522 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=345 Participants	1 Participants n=177 Participants	1 Participants n=522 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=345 Participants	1 Participants n=177 Participants	1 Participants n=522 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=345 Participants	1 Participants n=177 Participants	3 Participants n=522 Participants
Biologic-inadequate Responder (Bio-IR) Status Bio-IR	175 Participants n=345 Participants	91 Participants n=177 Participants	266 Participants n=522 Participants
Biologic-inadequate Responder (Bio-IR) Status Non-Bio-IR	170 Participants n=345 Participants	86 Participants n=177 Participants	256 Participants n=522 Participants
Baseline Corticosteroid Use Yes	123 Participants n=345 Participants	75 Participants n=177 Participants	198 Participants n=522 Participants
Baseline Corticosteroid Use No	222 Participants n=345 Participants	102 Participants n=177 Participants	324 Participants n=522 Participants
Adapted Mayo Score Strata ≤ 7	205 Participants n=345 Participants	104 Participants n=177 Participants	309 Participants n=522 Participants
Adapted Mayo Score Strata > 7	138 Participants n=345 Participants	73 Participants n=177 Participants	211 Participants n=522 Participants
Adapted Mayo Score Strata Missing	2 Participants n=345 Participants	0 Participants n=177 Participants	2 Participants n=522 Participants
Bio-IR: Number of Prior Biologic Treatments ≤ 1 prior biologic	58 Participants n=175 Participants • Biologic-inadequate responders	33 Participants n=91 Participants • Biologic-inadequate responders	91 Participants n=266 Participants • Biologic-inadequate responders
Bio-IR: Number of Prior Biologic Treatments > 1 prior biologic	117 Participants n=175 Participants • Biologic-inadequate responders	58 Participants n=91 Participants • Biologic-inadequate responders	175 Participants n=266 Participants • Biologic-inadequate responders
Non-Bio-IR: Prior Exposure to Biologic Therapy Yes	1 Participants n=170 Participants • Non-biologic-inadequate responders	5 Participants n=86 Participants • Non-biologic-inadequate responders	6 Participants n=256 Participants • Non-biologic-inadequate responders
Non-Bio-IR: Prior Exposure to Biologic Therapy No	169 Participants n=170 Participants • Non-biologic-inadequate responders	81 Participants n=86 Participants • Non-biologic-inadequate responders	250 Participants n=256 Participants • Non-biologic-inadequate responders
Disease Duration	7.273 years STANDARD_DEVIATION 6.4459 • n=345 Participants	7.584 years STANDARD_DEVIATION 7.6701 • n=177 Participants	7.379 years STANDARD_DEVIATION 6.8804 • n=522 Participants
Adapted Mayo Score	7.00 units on a scale STANDARD_DEVIATION 1.216 • n=343 Participants • Participants with available data	7.05 units on a scale STANDARD_DEVIATION 1.236 • n=177 Participants • Participants with available data	7.02 units on a scale STANDARD_DEVIATION 1.222 • n=520 Participants • Participants with available data
Average Stool Frequency Subscore	2.55 units on a scale STANDARD_DEVIATION 0.626 • n=343 Participants • Participants with available data	2.64 units on a scale STANDARD_DEVIATION 0.551 • n=177 Participants • Participants with available data	2.58 units on a scale STANDARD_DEVIATION 0.603 • n=520 Participants • Participants with available data
Average Rectal Bleeding Subscore	1.77 units on a scale STANDARD_DEVIATION 0.966 • n=343 Participants • Participants with available data	1.71 units on a scale STANDARD_DEVIATION 1.049 • n=177 Participants • Participants with available data	1.75 units on a scale STANDARD_DEVIATION 0.995 • n=520 Participants • Participants with available data
Average Endoscopy Subscore	2.7 units on a scale STANDARD_DEVIATION 0.47 • n=344 Participants • Participants with available data	2.7 units on a scale STANDARD_DEVIATION 0.46 • n=177 Participants • Participants with available data	2.7 units on a scale STANDARD_DEVIATION 0.46 • n=521 Participants • Participants with available data

PRIMARY outcome

Timeframe: Week 8

Population: The Part 1 intent-to-treat population (ITT1) includes randomized participants who received at least 1 dose of study drug in Part 1. The ITT1 population excludes 6 participants from 1 site with non-compliance. Non-responder imputation incorporating multiple imputation to handle missing data due to Coronavirus Disease - 2019 (COVID-19) was used.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8	33.5 percentage of participants Interval 28.5 to 38.5	4.1 percentage of participants Interval 1.1 to 7.1

SECONDARY outcome

Timeframe: Week 8

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

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).

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants With Endoscopic Improvement at Week 8	44.0 percentage of participants Interval 38.8 to 49.3	8.3 percentage of participants Interval 4.1 to 12.5

SECONDARY outcome

Timeframe: Week 8

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

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).

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants With Endoscopic Remission at Week 8	18.2 percentage of participants Interval 14.1 to 22.3	1.7 percentage of participants Interval 0.0 to 3.7

SECONDARY outcome

Timeframe: Week 8

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

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.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8	74.5 percentage of participants Interval 69.9 to 79.1	25.4 percentage of participants Interval 18.9 to 31.8

SECONDARY outcome

Timeframe: Week 2

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

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.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2	63.3 percentage of participants Interval 58.2 to 68.5	25.9 percentage of participants Interval 19.4 to 32.4

SECONDARY outcome

Timeframe: Week 8

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

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.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8	36.7 percentage of participants Interval 31.6 to 41.8	5.9 percentage of participants Interval 2.3 to 9.4

SECONDARY outcome

Timeframe: Week 8

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

Bowel urgency was assessed by participants in a subject diary completed once a day.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants Who Reported No Bowel Urgency at Week 8	53.7 percentage of participants Interval 48.4 to 59.0	25.9 percentage of participants Interval 19.4 to 32.4

SECONDARY outcome

Timeframe: Week 8

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

Abdominal pain was assessed by participants in a subject diary completed once a day.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants Who Reported No Abdominal Pain at Week 8	53.7 percentage of participants Interval 48.4 to 59.0	24.1 percentage of participants Interval 17.8 to 30.5

SECONDARY outcome

Timeframe: Week 8

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

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.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants Who Achieved Histologic Improvement at Week 8	62.2 percentage of participants Interval 57.0 to 67.3	24.5 percentage of participants Interval 18.0 to 30.9

SECONDARY outcome

Timeframe: Baseline (Week 0) to Week 8

Population: ITT1 population with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases up to Week 8 was used except for measurements at or after the occurrence of UC-related corticosteroids intercurrent event were excluded.

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.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=315 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=156 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8	52.2 units on a scale Interval 48.57 to 55.92	21.1 units on a scale Interval 15.98 to 26.17

SECONDARY outcome

Timeframe: Week 8

Population: ITT1 population; non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 was used.

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.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=341 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=174 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Percentage of Participants Who Achieved Mucosal Healing at Week 8	13.5 percentage of participants Interval 9.9 to 17.1	1.7 percentage of participants Interval 0.0 to 3.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Upadacitinib 45 mg n=312 Participants Participants received 45 mg upadacitinib once daily for 8 weeks.	Placebo n=155 Participants Participants received placebo matching to upadacitinib once daily for 8 weeks.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8	9.4 units on a scale Interval 8.38 to 10.48	3.5 units on a scale Interval 2.02 to 4.92

Adverse Events

Part 1: Upadacitinib 45 mg

Serious events: 11 serious events

Other events: 32 other events

Deaths: 0 deaths

Part 1: Placebo

Serious events: 8 serious events

Other events: 11 other events

Deaths: 0 deaths

Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Part 2: Placebo / Upadacitinib 45 mg

Serious events: 4 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Part 1: Upadacitinib 45 mg n=344 participants at risk Participants received 45 mg upadacitinib once daily (QD) for 8 weeks.	Part 1: Placebo n=177 participants at risk Participants received placebo matching to upadacitinib once daily for 8 weeks.	Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg n=68 participants at risk Participants initially assigned to upadacitinib who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.	Part 2: Placebo / Upadacitinib 45 mg n=116 participants at risk Participants initially assigned to placebo who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/344 • 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).	0.00% 0/177 • 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).	5.9% 4/68 • Number of events 4 • 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).	2.6% 3/116 • Number of events 3 • 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).
General disorders PYREXIA	0.00% 0/344 • 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).	0.00% 0/177 • 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).	5.9% 4/68 • Number of events 4 • 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).	3.4% 4/116 • Number of events 4 • 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).
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.00% 0/344 • 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).	0.00% 0/177 • 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).	5.9% 4/68 • Number of events 4 • 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).	4.3% 5/116 • Number of events 5 • 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).
Nervous system disorders HEADACHE	2.3% 8/344 • Number of events 9 • 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).	5.1% 9/177 • Number of events 10 • 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).	0.00% 0/68 • 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).	0.00% 0/116 • 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).
Skin and subcutaneous tissue disorders ACNE	7.0% 24/344 • Number of events 25 • 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).	1.7% 3/177 • Number of events 3 • 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).	0.00% 0/68 • 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).	5.2% 6/116 • Number of events 6 • 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).

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