Brief 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.
Brief Title
A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
Categories
Completion Date
Completion Date Type
Actual
Conditions
Hidradenitis Suppurativa
Eligibility Criteria
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:
* 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.
* 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:
* 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.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
Hidradenitis Suppurativa
Risankizumab
Placebo
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03926169
Org Class
Industry
Org Full Name
AbbVie
Org Study Id
M16-833
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
Outcome Time Frame
Baseline (Week 0), Week 16
Secondary Ids
Secondary Id
2019-000122-21
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0) to Week 8
Outcome Measure
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
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0) to Week 16
Outcome Measure
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
Outcome Time Frame
Baseline (Week 0) to Week 16
Outcome Measure
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
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0) to Week 16
Outcome Measure
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0) to Week 16
Outcome Measure
Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0) to Week 16
Outcome Measure
Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
Outcome Description
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.
Outcome Time Frame
Baseline (Week 0) to Week 16
Outcome Measure
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kristina Campton
Investigator Email
kcampton@montefiore.org
Investigator Phone