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CompletedNCT03926169DETERMINED 1Updated Aug 11, 2022Results posted

A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

A Phase 2 interventional study of Risankizumab and Placebo for risankizumab in Hidradenitis Suppurativa, sponsored by AbbVie. Completed at 59 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-11.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
243
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.

02

Conditions studied

  • Hidradenitis Suppurativa

Keywords

  • Hidradenitis Suppurativa
  • Risankizumab
  • Placebo
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 243 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participant with moderate to severe HS for at least 1 year prior to baseline visit.
  • HS lesions present in at least two distinct anatomical areas.
  • Draining fistula count of ≤ 20 at Baseline visit.
  • Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.
  • Participants are required to use a daily antiseptic wash on their HS lesions.
  • Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.

Exclusion criteria

Exclusion Criteria:

  • Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
  • Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
  • Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
  • Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
  • Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
  • Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
243 participants (actual)

Study arms

  • Experimental
    Risankizumab 180 mg

    In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

    Drug: Risankizumab

  • Experimental
    Risankizumab 360 mg

    In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

    Drug: Risankizumab

  • Placebo comparator
    Placebo

    In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

    Drug: Placebo for risankizumab

  • Experimental
    Risankizumab 180 mg / Risankizumab 360 mg

    In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.

    Drug: Risankizumab · Drug: Placebo for risankizumab

  • Experimental
    Risankizumab 360 mg / Risankizumab 360 mg

    In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.

    Drug: Risankizumab · Drug: Placebo for risankizumab

  • Placebo comparator
    Placebo / Risankizumab 360 mg

    In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.

    Drug: Risankizumab · Drug: Placebo for risankizumab

Interventions

  • DrugRisankizumab

    Risankizumab is administered as a SC injection in pre-filled syringe (PFS)

    Also known as: ABBV-066, SKYRIZI

  • DrugPlacebo for risankizumab

    Placebo for risankizumab is administered as a SC injection in PFS

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

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

    Time frame: Baseline (Week 0), Week 16

Secondary outcomes

  1. Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3

    NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

    Time frame: Baseline (Week 0) to Week 8

  2. Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3

    NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

    Time frame: Baseline (Week 0) to Week 16

  3. Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline

    Time frame: Baseline (Week 0) to Week 16

  4. Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16

    The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.

    Time frame: Baseline (Week 0) to Week 16

  5. Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16

    HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

    Time frame: Baseline (Week 0) to Week 16

  6. Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16

    HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

    Time frame: Baseline (Week 0) to Week 16

  7. Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16

    HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

    Time frame: Baseline (Week 0) to Week 16

07

Results

Posted Aug 11, 2022

Participant flow

Period A
Participant flow — Period A
MilestonePlacebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mg
Started828081
Never received study drug001
Completed747075
Not completed8106
Withdrew: Adverse event221
Withdrew: Withdrawal by subject222
Withdrew: Lost to follow-up310
Withdrew: Lack of efficacy022
Withdrew: Covid-19 infection010
Withdrew: Covid-19 logistical restrictions021
Withdrew: Other, not specified100
Period B
Participant flow — Period B
MilestonePlacebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mg
Started747075
Entered period b and received study drug747074
Completed474
Not completed706371
Withdrew: Adverse event311
Withdrew: Withdrawal by subject130
Withdrew: Lack of efficacy311
Withdrew: Lost to follow-up114
Withdrew: Other, not specified625765

Outcome measures

PrimaryPercentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

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

Time frame:
Baseline (Week 0), Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
percentage of participantsPlaceboRisankizumab 180 mgRisankizumab 360 mg
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 1641.5 (29.3 to 53.7)46.8 (34.2 to 59.4)43.4 (31.0 to 55.8)
Statistical analysis
  • Placebo vs Risankizumab 180 mg · Cochran-Mantel-Haenszel · p = 0.422 (Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.) · Adjusted response rate difference (%): 6.0 · 97.5% CI -10.8 to 22.8
  • Placebo vs Risankizumab 360 mg · Cochran-Mantel-Haenszel · p = 0.858 (Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.) · Adjusted response rate difference (%): 1.3 · 97.5% CI -15.4 to 18.1
SecondaryPercentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3

NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

Time frame:
Baseline (Week 0) to Week 8
Reported as:
Number · percentage of participants
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
percentage of participantsPlaceboRisankizumab 180 mgRisankizumab 360 mg
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 333.0 (19.4 to 46.5)29.2 (15.9 to 42.6)40.0 (25.8 to 54.2)
Statistical analysis
  • Placebo vs Risankizumab 180 mg · Cochran-Mantel-Haenszel · p = 0.725 (Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.) · Adjusted response rate difference (%): -3.0 · 97.5% CI -21.8 to 15.9
  • Placebo vs Risankizumab 360 mg · Cochran-Mantel-Haenszel · p = 0.301 (Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.) · Adjusted response rate difference (%): 8.8 · 97.5% CI -10.3 to 27.8
SecondaryPercentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3

NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

Time frame:
Baseline (Week 0) to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3
percentage of participantsPlaceboRisankizumab 180 mgRisankizumab 360 mg
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 327.9 (15.0 to 40.7)31.1 (17.5 to 44.7)38.6 (24.4 to 52.7)
Statistical analysis
  • Placebo vs Risankizumab 180 mg · Cochran-Mantel-Haenszel · p = 0.650 (Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.) · Adjusted response rate difference (%): 3.7 · 97.5% CI -14.5 to 21.8
  • Placebo vs Risankizumab 360 mg · Cochran-Mantel-Haenszel · p = 0.147 (Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.) · Adjusted response rate difference (%): 12.3 · 97.5% CI -6.7 to 31.3
SecondaryPercentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline
Time frame:
Baseline (Week 0) to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline
percentage of participantsPlaceboRisankizumab 180 mgRisankizumab 360 mg
Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline29.3 (18.0 to 40.5)22.5 (12.0 to 33.0)18.5 (8.8 to 28.2)
Statistical analysis
  • Placebo vs Risankizumab 180 mg · Cochran-Mantel-Haenszel · p = 0.342 (Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.) · Adjusted response rate difference (%): -6.5 · 97.5% CI -21.8 to 8.8
  • Placebo vs Risankizumab 360 mg · Cochran-Mantel-Haenszel · p = 0.108 (Across the strata, 97.5% confidence interval for adjusted difference and P-value were calculated according to the Cochran-Mantel-Haenszel test adjusted for the actual values stratification factors under a two-sided alpha level 0.025 for each dose.) · Adjusted response rate difference (%): -10.6 · 97.5% CI -25.3 to 4.2
SecondaryChange From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16

The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.

Time frame:
Baseline (Week 0) to Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
score on a scalePlaceboRisankizumab 180 mgRisankizumab 360 mg
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16-2.1 (-3.9 to -0.4)-3.5 (-5.2 to -1.8)-3.7 (-5.5 to -2.0)
Statistical analysis
  • Placebo vs Risankizumab 180 mg · mixed-effect model repeat measures · p = 0.179 (Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.) · Ls mean difference: -1.3 · 97.5% CI -3.5 to 0.9
  • Placebo vs Risankizumab 360 mg · mixed-effect model repeat measures · p = 0.105 (Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.) · Ls mean difference: -1.6 · 97.5% CI -3.8 to 0.6
SecondaryChange From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16

HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

Time frame:
Baseline (Week 0) to Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
score on a scalePlaceboRisankizumab 180 mgRisankizumab 360 mg
Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16-0.870 (-1.416 to -0.324)-0.751 (-1.338 to -0.165)-0.885 (-1.436 to -0.334)
Statistical analysis
  • Placebo vs Risankizumab 180 mg · mixed-effect model repeat measures · p = 0.727 (Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.) · Ls mean difference: 0.118 · 97.5% CI -0.646 to 0.883
  • Placebo vs Risankizumab 360 mg · mixed-effect model repeat measures · p = 0.963 (Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.) · Ls mean difference: -0.015 · 97.5% CI -0.755 to 0.724
SecondaryChange From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16

HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

Time frame:
Baseline (Week 0) to Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
score on a scalePlaceboRisankizumab 180 mgRisankizumab 360 mg
Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16-0.677 (-1.160 to -0.195)-0.635 (-1.149 to -0.120)-0.442 (-0.928 to 0.044)
Statistical analysis
  • Placebo vs Risankizumab 180 mg · mixed-effect model repeat measures · p = 0.886 (Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.) · Ls mean difference: 0.042 · 97.5% CI -0.622 to 0.706
  • Placebo vs Risankizumab 360 mg · mixed-effect model repeat measures · p = 0.409 (Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.) · Ls mean difference: 0.236 · 97.5% CI -0.408 to 0.879
SecondaryChange From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16

HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

Time frame:
Baseline (Week 0) to Week 16
Reported as:
Least squares mean · score on a scale
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
score on a scalePlaceboRisankizumab 180 mgRisankizumab 360 mg
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16-0.630 (-1.154 to -0.107)-0.882 (-1.440 to -0.324)-0.705 (-1.233 to -0.176)
Statistical analysis
  • Placebo vs Risankizumab 180 mg · mixed-effect model repeat measures · p = 0.434 (Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.) · Ls mean difference: -0.252 · 97.5% CI -0.977 to 0.473
  • Placebo vs Risankizumab 360 mg · mixed-effect model repeat measures · p = 0.813 (Mixed-effect model repeat measures analysis with treatment, visit, treatment by visit interaction, stratification factor and baseline measurement in the model. An unstructured variance covariance matrix is used.) · Ls mean difference: -0.074 · 97.5% CI -0.779 to 0.631

Adverse events

Collected over From the first dose of study medication until 20 weeks after the last dose. Part A overall mean duration on study drug was 108.5 days. Part B overall mean duration on study drug was 179.9 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/82 (0%)2/82 (2.4%)19/82 (23.2%)
Risankizumab 180 mg0/80 (0%)3/80 (3.8%)21/80 (26.3%)
Risankizumab 360 mg0/80 (0%)2/80 (2.5%)26/80 (32.5%)
Placebo / Risankizumab 360 mg0/74 (0%)3/74 (4.1%)26/74 (35.1%)
Risankizumab 180 mg / Risankizumab 360 mg0/70 (0%)4/70 (5.7%)12/70 (17.1%)
Risankizumab 360 mg / Risankizumab 360 mg0/74 (0%)0/74 (0%)19/74 (25.7%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventPlaceboRisankizumab 180 mgRisankizumab 360 mgPlacebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mg
SMALL INTESTINAL OBSTRUCTIONGastrointestinal disorders0/820/801/800/741/700/74
TONSILLITISInfections and infestations0/820/800/800/741/700/74
URINARY TRACT INFECTIONInfections and infestations0/820/800/800/741/700/74
INTERVERTEBRAL DISC PROTRUSIONMusculoskeletal and connective tissue disorders0/820/800/800/741/700/74
DEEP VEIN THROMBOSISVascular disorders0/820/800/800/741/700/74
APPENDICITISInfections and infestations0/820/800/801/740/700/74
CELLULITISInfections and infestations0/820/800/801/740/700/74
BREAST CANCERNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/820/800/801/740/700/74
ENDOMETRIOSISReproductive system and breast disorders0/820/800/801/740/700/74
OVARIAN CYSTReproductive system and breast disorders0/820/800/801/740/700/74
Most frequent other events
Most frequent other events
EventPlaceboRisankizumab 180 mgRisankizumab 360 mgPlacebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mg
HEADACHENervous system disorders9/826/8011/807/741/704/74
HIDRADENITISSkin and subcutaneous tissue disorders7/823/802/806/748/7010/74
NASOPHARYNGITISInfections and infestations3/826/807/801/744/701/74
DIARRHOEAGastrointestinal disorders4/822/802/805/741/702/74
URINARY TRACT INFECTIONInfections and infestations1/824/803/804/740/700/74
ECZEMASkin and subcutaneous tissue disorders0/820/802/801/740/704/74
UPPER RESPIRATORY TRACT INFECTIONInfections and infestations1/821/804/802/740/700/74
BACK PAINMusculoskeletal and connective tissue disorders2/823/804/802/740/701/74

Baseline characteristics

Age, Continuous
Age, Continuous(years)Placebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mgTotal
Mean37.2 ± 11.9738.9 ± 11.4538.2 ± 11.9938.1 ± 11.77
Sex: Female, Male
Sex: Female, Male(Participants)Placebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mgTotal
Female485351152
Male34273091
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mgTotal
Hispanic or Latino910726
Not Hispanic or Latino737074217
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Placebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mgTotal
White686362193
Black or African American412925
Asian84921
American Indian or Alaska Native0101
Multiple Races2013
Abscess and Inflammatory Nodule (AN) Count
Abscess and Inflammatory Nodule (AN) Count(abscess and inflammatory nodules)Placebo / Risankizumab 360 mgRisankizumab 180 mg / Risankizumab 360 mgRisankizumab 360 mg / Risankizumab 360 mgTotal
Mean15.7 ± 28.4213.7 ± 11.4212.5 ± 8.2414.0 ± 18.36
08

Study locations

59 sites
  • Burke Pharmaceutical Research /ID# 211671
    Hot Springs, Arkansas 71913-6404, United States
  • Bakersfield Derma & Skin Cance /ID# 211684
    Bakersfield, California 93309, United States
  • Wallace Medical Group /ID# 215958
    Los Angeles, California 90056, United States
  • Integrative Skin Science and Research /ID# 212550
    Sacramento, California 95815-4500, United States
  • UC Davis Health /ID# 211436
    Sacramento, California 95816-3300, United States
  • California Dermatology Institute /ID# 211786
    Thousand Oaks, California 91320-2130, United States
  • CCD Research, PLLC /ID# 214479
    Cromwell, Connecticut 06416-1745, United States
  • Advanced Medical Research /ID# 215203
    Sandy Springs, Georgia 30328-6141, United States
  • Arlington Dermatology /ID# 219096
    Rolling Meadows, Illinois 60008, United States
  • Tufts Medical Center /ID# 212680
    Boston, Massachusetts 02111-1552, United States
  • Beth Israel Deaconess Medical Center /ID# 211794
    Boston, Massachusetts 02215-5400, United States
  • Hamzavi Dermatology /ID# 212318
    Fort Gratiot, Michigan 48059, United States
  • University of Minnesota /ID# 212319
    Minneapolis, Minnesota 55455-0356, United States
  • Minnesota Clinical Study Center /ID# 211979
    New Brighton, Minnesota 55112, United States
  • Skin Specialists, PC /ID# 211675
    Omaha, Nebraska 68144, United States
  • Montefiore Medical Center - Moses Campus /ID# 211800
    Bronx, New York 10467, United States
  • Oregon Medical Res Center PC /ID# 211796
    Portland, Oregon 97223, United States
  • Penn State Hershey Medical Ctr /ID# 211659
    Hershey, Pennsylvania 17033-2360, United States
  • Rhode Island Hospital /ID# 211807
    Providence, Rhode Island 02903, United States
  • Modern Research Associates, PL /ID# 215202
    Dallas, Texas 75231, United States
  • Virginia Clinical Research, Inc. /ID# 215959
    Norfolk, Virginia 23507, United States
  • Premier Clinical Research /ID# 211799
    Spokane, Washington 99202, United States
  • Woden Dermatology /ID# 212437
    Phillip, Australian Capital Territory 2606, Australia
  • Westmead Hospital /ID# 212438
    Westmead, New South Wales 2145, Australia
  • Veracity Clinical Research /ID# 212432
    Woolloongabba, Queensland 4102, Australia
  • Skin Health Institute Inc /ID# 212433
    Carlton, Victoria 3053, Australia
  • Sinclair Dermatology /ID# 215548
    East Melbourne, Victoria 3002, Australia
  • The Royal Melbourne Hospital /ID# 212436
    Parkville, Victoria 3050, Australia
  • Fremantle Dermatology /ID# 212434
    Fremantle, Western Australia 6160, Australia
  • Wiseman Dermatology Research /ID# 212243
    Winnipeg, Manitoba R3M 3Z4, Canada
  • Dr. Irina Turchin PC Inc. /ID# 212248
    Fredericton, New Brunswick E3B 1G9, Canada
  • Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043
    Newmarket, Ontario L3Y 5G8, Canada
  • K. Papp Clinical Research /ID# 212166
    Waterloo, Ontario N2J 1C4, Canada
  • Dre Angelique Gagne-Henley M.D. inc. /ID# 212249
    Saint-Jerome, Quebec J7Z 7E2, Canada
  • Chu de Nice-Hopital L'Archet Ii /Id# 212563
    Nice, Alpes-Maritimes 06200, France
  • Hopital Prive d'Antony /ID# 212566
    Antony, Ile-de-France 92160, France
  • CHU de SAINT ETIENNE - Hopital Nord /ID# 212564
    St. Priest En Jarez, Loire 42270, France
  • HCL - Hopital Edouard Herriot /ID# 218408
    Lyon, 69003, France
  • Polyclinique Courlancy /ID# 212567
    Reims, 51100, France
  • CHU Toulouse - Hopital Larrey /ID# 213581
    Toulouse, 31400, France
  • Universitaetsklinikum Frankfurt /ID# 211913
    Frankfurt am Main, Hessen 60590, Germany
  • Klinikum Ruhr Univ Bochum /ID# 211910
    Bochum, 44791, Germany
  • Staedtisches Klinikum Dessau /ID# 211914
    Dessau, 06847, Germany
  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912
    Hamburg, 20246, Germany
  • Nagoya City University Hospital /ID# 211155
    Nagoya shi, Aichi 467-8602, Japan
  • Fukuoka University Hospital /ID# 211303
    Fukuoka-shi, Fukuoka 814-0180, Japan
  • Tohoku University Hospital /ID# 212214
    Sendai-shi, Miyagi 9808574, Japan
  • University of the Ryukyus Hospital /ID# 211373
    Nakagami-gun, Okinawa 903-0215, Japan
  • Toranomon Hospital /ID# 211742
    Minato-ku, Tokyo 105-8470, Japan
  • Bravis Ziekenhuis /ID# 212536
    Bergen op Zoom, Noord-Brabant 4624 VT, Netherlands
  • Erasmus Medisch Centrum /ID# 212535
    Rotterdam, Zuid-Holland 3015 GD, Netherlands
  • Amphia Ziekenhuis /ID# 212538
    Breda, 4818 CK, Netherlands
  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015
    Sabadell, Barcelona 08208, Spain
  • Hospital de Manises /ID# 211541
    Manises, Valencia 46940, Spain
  • Hospital General Universitario Alicante /ID# 212010
    Alicante, 03010, Spain
  • Hospital Santa Creu i Sant Pau /ID# 212009
    Barcelona, 08041, Spain
  • Hospital Universitario Virgen de las Nieves /ID# 212014
    Granada, 18014, Spain
  • Hospital General Universitario Gregorio Maranon /ID# 212011
    Madrid, 28007, Spain
  • Hospital Universitario Virgen de la Victoria /ID# 212013
    Malaga, 29010, Spain
09

References and documents

Study documents

  • Study protocol · Dec 15, 2020
  • Statistical analysis plan · Jan 19, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03926169
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Apr 24, 2019
Start date
Jun 3, 2019
Primary completion
Feb 2, 2021
Completion
Aug 2, 2021
Results posted
Aug 11, 2022
Last update
Aug 11, 2022

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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