Trial Outcomes & Findings for A Study of Oral Upadacitinib Tablet Compared to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa to Assess Change in Disease Symptoms (NCT NCT04430855)

Last Updated: 2023-02-06

Results Overview

HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

68 participants

Primary outcome timeframe

Baseline and Week 12

Results posted on

2023-02-06

Participant Flow

Participants were enrolled at 21 study sites in 3 countries (Canada, Japan, and United States/Puerto Rico).

Participants were randomized to upadacitinib or placebo in a 2:1 ratio. Randomization was stratified by anti-tumor necrosis factor (TNF) use prior to Baseline (yes or no) and Hurley stage (\< III or III).

Participant milestones

Participant milestones
Measure	Placebo / Upadacitinib 15 mg Participants received matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).	Upadacitinib 30 mg Participants received 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).
Period 1 (Weeks 1-12) STARTED	21	47
Period 1 (Weeks 1-12) Received Study Drug	21	47
Period 1 (Weeks 1-12) COMPLETED	19	41
Period 1 (Weeks 1-12) NOT COMPLETED	2	6
Period 2 (Weeks 12-48) STARTED	19	41
Period 2 (Weeks 12-48) COMPLETED	14	31
Period 2 (Weeks 12-48) NOT COMPLETED	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo / Upadacitinib 15 mg Participants received matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).	Upadacitinib 30 mg Participants received 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).
Period 1 (Weeks 1-12) Adverse Event	1	0
Period 1 (Weeks 1-12) Withdrawal by Subject	1	2
Period 1 (Weeks 1-12) Lost to Follow-up	0	2
Period 1 (Weeks 1-12) Lack of Efficacy	0	1
Period 1 (Weeks 1-12) Other	0	1
Period 2 (Weeks 12-48) Withdrawal by Subject	2	5
Period 2 (Weeks 12-48) Lost to Follow-up	1	2
Period 2 (Weeks 12-48) Lack of Efficacy	2	3

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo / Upadacitinib 15 mg n=21 Participants Participants received matching placebo orally once a day for 12 weeks (Period 1) followed by 15 mg upadacitinib orally once a day for 36 weeks (Period 2).	Upadacitinib 30 mg n=47 Participants Participants received 30 mg upadacitinib orally once a day for 12 weeks (Period 1) followed by 30 mg upadacitinib orally once a day for 36 weeks (Period 2).	Total n=68 Participants Total of all reporting groups
Age, Continuous	36.6 years STANDARD_DEVIATION 12.49 • n=21 Participants	36.7 years STANDARD_DEVIATION 11.70 • n=47 Participants	36.6 years STANDARD_DEVIATION 11.85 • n=68 Participants
Age, Customized < 40 years	15 Participants n=21 Participants	29 Participants n=47 Participants	44 Participants n=68 Participants
Age, Customized 40 - < 65 years	5 Participants n=21 Participants	17 Participants n=47 Participants	22 Participants n=68 Participants
Age, Customized ≥ 65 years	1 Participants n=21 Participants	1 Participants n=47 Participants	2 Participants n=68 Participants
Sex: Female, Male Female	16 Participants n=21 Participants	37 Participants n=47 Participants	53 Participants n=68 Participants
Sex: Female, Male Male	5 Participants n=21 Participants	10 Participants n=47 Participants	15 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=21 Participants	9 Participants n=47 Participants	14 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=21 Participants	38 Participants n=47 Participants	54 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants	0 Participants n=47 Participants	0 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=21 Participants	1 Participants n=47 Participants	1 Participants n=68 Participants
Race (NIH/OMB) Asian	3 Participants n=21 Participants	3 Participants n=47 Participants	6 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants	0 Participants n=47 Participants	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	7 Participants n=21 Participants	12 Participants n=47 Participants	19 Participants n=68 Participants
Race (NIH/OMB) White	11 Participants n=21 Participants	30 Participants n=47 Participants	41 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=21 Participants	1 Participants n=47 Participants	1 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants	0 Participants n=47 Participants	0 Participants n=68 Participants
Prior Exposure to Tumor Necrosis Factor (TNF) Antagonists Yes	6 Participants n=21 Participants	12 Participants n=47 Participants	18 Participants n=68 Participants
Prior Exposure to Tumor Necrosis Factor (TNF) Antagonists No	15 Participants n=21 Participants	35 Participants n=47 Participants	50 Participants n=68 Participants
Hurley Stage Stage I	1 Participants n=21 Participants	0 Participants n=47 Participants	1 Participants n=68 Participants
Hurley Stage Stage II	11 Participants n=21 Participants	24 Participants n=47 Participants	35 Participants n=68 Participants
Hurley Stage Stage III	9 Participants n=21 Participants	23 Participants n=47 Participants	32 Participants n=68 Participants
Duration of Hidradenitis Suppurativa (HS) Disease	9.83 years STANDARD_DEVIATION 4.990 • n=21 Participants	11.52 years STANDARD_DEVIATION 9.401 • n=47 Participants	11.00 years STANDARD_DEVIATION 8.290 • n=68 Participants
Abscess Lesion Count	4.0 abscess lesions STANDARD_DEVIATION 3.29 • n=21 Participants	4.8 abscess lesions STANDARD_DEVIATION 6.39 • n=47 Participants	4.6 abscess lesions STANDARD_DEVIATION 5.60 • n=68 Participants
Inflammatory Nodule Lesion Count	15.7 nodule lesions STANDARD_DEVIATION 12.77 • n=21 Participants	18.4 nodule lesions STANDARD_DEVIATION 20.98 • n=47 Participants	17.6 nodule lesions STANDARD_DEVIATION 18.78 • n=68 Participants
Draining Fistula Lesion Count	4.3 draining fistula lesions STANDARD_DEVIATION 6.17 • n=21 Participants	3.4 draining fistula lesions STANDARD_DEVIATION 4.74 • n=47 Participants	3.7 draining fistula lesions STANDARD_DEVIATION 5.19 • n=68 Participants
Abscess and Inflammatory Nodule (AN) Count	19.8 abscesses and inflammatory nodules STANDARD_DEVIATION 12.87 • n=21 Participants	23.2 abscesses and inflammatory nodules STANDARD_DEVIATION 24.64 • n=47 Participants	22.1 abscesses and inflammatory nodules STANDARD_DEVIATION 21.65 • n=68 Participants
Patient's Global Assessment (PGA) of Skin Pain Score	4.852 units on a scale STANDARD_DEVIATION 3.3237 • n=20 Participants • Participants with available data	4.987 units on a scale STANDARD_DEVIATION 2.7120 • n=45 Participants • Participants with available data	4.945 units on a scale STANDARD_DEVIATION 2.8879 • n=65 Participants • Participants with available data
PGA Skin Pain Score In Participants with a Baseline Value ≥ 3	7.168 units on a scale STANDARD_DEVIATION 2.0395 • n=12 Participants • Participants with a Baseline PGA skin pain score ≥ 3	6.180 units on a scale STANDARD_DEVIATION 2.1107 • n=33 Participants • Participants with a Baseline PGA skin pain score ≥ 3	6.444 units on a scale STANDARD_DEVIATION 2.1155 • n=45 Participants • Participants with a Baseline PGA skin pain score ≥ 3

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-treat population; participants with missing data at Week 12 due to a missing assessment or early discontinuation, for reasons other than coronavirus disease 2019 (COVID-19), and participants who initiated antibiotics for HS-related infections prior to Week 12 were counted as non-responders (non-responder imputation); missing data due to COVID-19 infection or logistical restriction were handled by multiple imputation.

HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

Outcome measures

Outcome measures
Measure	Placebo n=21 Participants Participants received matching placebo orally once a day for 12 weeks.	Upadacitinib 30 mg n=47 Participants Participants received 30 mg upadacitinib orally once a day for 12 weeks.
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12	23.8 percentage of participants Interval 5.6 to 42.0	38.3 percentage of participants Interval 24.4 to 52.2

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-treat population with Baseline skin pain NRS ≥ 3; participants with missing data at Week 12 due to a missing assessment or early discontinuation, for reasons other than COVID-19, and participants who initiated antibiotics for HS-related infections prior to Week 12 and under the impact of analgesic use at Week 12 were counted as non-responders (non-responder imputation); missing data due to COVID-19 infection or logistical restriction were handled by multiple imputation.

The Patient's Global Assessment (PGA) of Skin Pain Numeric Rating Scale (NRS) was used to assess the worst skin pain due to HS. Participants were asked to rate their worst skin pain in the last 24 hours on an 11-point numerical rating scale ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine) on a daily basis using an electronic diary. The weekly average score was calculated based on the daily scores from the 7 days prior to the visit (with non-missing values in 4 or more days of the 7 day period). NRS30 is defined as the percentage of participants who achieved at least a 30% reduction and at least 1 unit reduction from Baseline in the PGA of skin pain NRS in participants with Baseline skin pain NRS ≥ 3.

Outcome measures

Outcome measures
Measure	Placebo n=12 Participants Participants received matching placebo orally once a day for 12 weeks.	Upadacitinib 30 mg n=33 Participants Participants received 30 mg upadacitinib orally once a day for 12 weeks.
Percentage of Participants Achieving PGA Skin Pain Numeric Rating Scale 30 (NRS30) Response at Week 12 Among Participants With Baseline NRS ≥ 3	33.3 percentage of participants Interval 6.7 to 60.0	36.4 percentage of participants Interval 20.0 to 52.8

Adverse Events

Period 1: Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Period 1: Upadacitinib 30 mg

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Period 2: Upadacitinib 15 mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Period 2: Upadacitinib 30 mg

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Period 1: Placebo n=21 participants at risk Participants received matching placebo orally once a day for 12 weeks in Period 1.	Period 1: Upadacitinib 30 mg n=47 participants at risk Participants received 30 mg upadacitinib orally once a day for 12 weeks in Period 1.	Period 2: Upadacitinib 15 mg n=19 participants at risk Participants originally assigned to placebo received 15 mg upadacitinib orally once a day for 36 weeks in Period 2.	Period 2: Upadacitinib 30 mg n=41 participants at risk Participants originally assigned to upadacitinib 30 mg continued to receive 30 mg upadacitinib orally once a day for 36 weeks in Period 2.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/47 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.4% 1/41 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Infections and infestations COVID-19 PNEUMONIA	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.1% 1/47 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/41 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Infections and infestations CELLULITIS	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/47 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.4% 1/41 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Psychiatric disorders ADJUSTMENT DISORDER	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/47 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.4% 1/41 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Psychiatric disorders DEPRESSION	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/47 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.4% 1/41 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Psychiatric disorders SUICIDAL BEHAVIOUR	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/47 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.4% 1/41 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/47 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.4% 1/41 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.1% 1/47 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/41 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Skin and subcutaneous tissue disorders HIDRADENITIS	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.1% 1/47 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/41 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Skin and subcutaneous tissue disorders SKIN PLAQUE	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/47 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.4% 1/41 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Surgical and medical procedures ABORTION INDUCED	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.1% 1/47 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/41 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).
Vascular disorders HYPOTENSION	0.00% 0/21 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/47 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	0.00% 0/19 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).	2.4% 1/41 • Number of events 1 • Period 1: From first dose of study drug up to the first dose of study drug during Period 2 (12 weeks). Period 2: From first dose of study drug in Period 2 up to 30 days after the last dose of study drug (maximum of 40 weeks).

Other adverse events

Additional Information

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