A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (DETERMINED 1)
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ClinicalTrials.gov Identifier: NCT03926169 |
Recruitment Status :
Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : January 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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Hidradenitis Suppurativa | Drug: Risankizumab Drug: Placebo for risankizumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 3, 2019 |
Estimated Primary Completion Date : | February 2, 2021 |
Estimated Study Completion Date : | April 26, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Risankizumab: Dose A
Participants randomized to receive risankizumab dose A in treatment period A and placebo followed by risankizumab dose B in treatment period B
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Drug: Risankizumab
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Other Names:
Drug: Placebo for risankizumab Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS) |
Experimental: Risankizumab: Dose B
Participants randomized to receive risankizumab dose B in treatment period A and placebo followed by risankizumab dose B in treatment period B
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Drug: Risankizumab
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Other Names:
Drug: Placebo for risankizumab Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS) |
Placebo Comparator: Placebo
Participants randomized to receive Placebo in treatment period A and risankizumab dose B in treatment period B
|
Drug: Risankizumab
Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
Other Names:
Drug: Placebo for risankizumab Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS) |
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) [ Time Frame: 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.
- Percentage of participants achieving at least 30% reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) at Week 8 among participants with Baseline Numerical Rating Scale (NRS) >= 3 [ Time Frame: Baseline (Week 0) to approximately Week 8 ]NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain).
- Percentage of participants achieving at least 30% reduction from Baseline in Numerical Rating Scale (NRS30) in Patient's Global Assessment of Skin Pain (PGA Skin Pain) at Week 16 among participants with Baseline Numerical Rating Scale (NRS) >= 3 [ Time Frame: Baseline (Week 0) to approximately Week 16 ]NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain).
- Percentage of participants who experience at least 25% increase in AN counts with a minimum increase of 2 relative to Baseline [ Time Frame: Baseline (Week 0) to approximately Week 16 ]Percentage of participants who experience at least 25% increase in AN counts with a minimum increase of 2 relative to Baseline is evaluated
- Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline (Week 0) to approximately 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.
- Change from Baseline in HS-related swelling assessed based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) [ Time Frame: Baseline (Week 0) to approximately Week 16 ]HSSA is a 9-item patient reported outcome (PRO) questionnaire developed to assess the symptoms of HS on a 0 to 11-point numerical rating scale (NRS), where 0 represents no symptoms and 10 represents extreme symptom experience.
- Change from Baseline in HS-related odor assessed based on the HSSA [ Time Frame: Baseline (Week 0) to approximately Week 16 ]HSSA is a 9-item patient reported outcome (PRO) questionnaire developed to assess the symptoms of HS on a 0 to 11-point numerical rating scale (NRS), where 0 represents no symptoms and 10 represents extreme symptom experience.
- Change from Baseline in HS-related worst drainage assessed based on the HSSA [ Time Frame: Baseline (Week 0) to approximately Week 16 ]HSSA is a 9-item patient reported outcome (PRO) questionnaire developed to assess the symptoms of HS on a 0 to 11-point numerical rating scale (NRS), where 0 represents no symptoms and 10 represents extreme symptom experience.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participant with moderate to severe Hidradenitis Suppurativa (HS) for at least one year prior to baseline visit.
- HS lesions present in at least two distinct anatomical areas.
- Draining fistula count of <=20 at Baseline visit.
- Total abscesses and nodule count (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 immuno deficiency 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926169

Study Director: | AbbVie Inc. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT03926169 |
Other Study ID Numbers: |
M16-833 2019-000122-21 ( EudraCT Number ) |
First Posted: | April 24, 2019 Key Record Dates |
Last Update Posted: | January 8, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | 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 Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. |
Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. |
URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Hidradenitis Suppurativa Risankizumab Placebo |
Hidradenitis Suppurativa Hidradenitis Sweat Gland Diseases Skin Diseases Skin Diseases, Bacterial Bacterial Infections |
Skin Diseases, Infectious Infection Suppuration Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |