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Hidradenitis SuppurativaPhase 2DETERMINED 1NCT03926169

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

A Phase 2 study testing Risankizumab in people with Hidradenitis Suppurativa, run by AbbVie at 59 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
243 participants
Where
59 sitesin 8 countries
Study dates
3 Jun 2019to 2 Aug 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

59 sites in 8 countries.

59 sites in 8 countries

United States22 sites

  • Bakersfield Derma & Skin Cance /ID# 211684

    Bakersfield, California, 93309

  • Tufts Medical Center /ID# 212680

    Boston, Massachusetts, 02111-1552

  • Beth Israel Deaconess Medical Center /ID# 211794

    Boston, Massachusetts, 02215-5400

  • CCD Research, PLLC /ID# 214479

    Cromwell, Connecticut, 06416-1745

  • Modern Research Associates, PL /ID# 215202

    Dallas, Texas, 75231

  • Hamzavi Dermatology /ID# 212318

    Fort Gratiot, Michigan, 48059

  • Penn State Hershey Medical Ctr /ID# 211659

    Hershey, Pennsylvania, 17033-2360

  • Burke Pharmaceutical Research /ID# 211671

    Hot Springs, Arkansas, 71913-6404

  • Wallace Medical Group /ID# 215958

    Los Angeles, California, 90056

  • University of Minnesota /ID# 212319

    Minneapolis, Minnesota, 55455-0356

  • Minnesota Clinical Study Center /ID# 211979

    New Brighton, Minnesota, 55112

  • Virginia Clinical Research, Inc. /ID# 215959

    Norfolk, Virginia, 23507

  • Skin Specialists, PC /ID# 211675

    Omaha, Nebraska, 68144

  • Oregon Medical Res Center PC /ID# 211796

    Portland, Oregon, 97223

  • Rhode Island Hospital /ID# 211807

    Providence, Rhode Island, 02903

  • Arlington Dermatology /ID# 219096

    Rolling Meadows, Illinois, 60008

  • Integrative Skin Science and Research /ID# 212550

    Sacramento, California, 95815-4500

  • UC Davis Health /ID# 211436

    Sacramento, California, 95816-3300

  • Advanced Medical Research /ID# 215203

    Sandy Springs, Georgia, 30328-6141

  • Premier Clinical Research /ID# 211799

    Spokane, Washington, 99202

  • Montefiore Medical Center - Moses Campus /ID# 211800

    The Bronx, New York, 10467

  • California Dermatology Institute /ID# 211786

    Thousand Oaks, California, 91320-2130

Other trials in United States

Australia7 sites

  • Skin Health Institute Inc /ID# 212433

    Carlton, Victoria, 3053

  • Sinclair Dermatology /ID# 215548

    East Melbourne, Victoria, 3002

  • Fremantle Dermatology /ID# 212434

    Fremantle, Western Australia, 6160

  • The Royal Melbourne Hospital /ID# 212436

    Parkville, Victoria, 3050

  • Woden Dermatology /ID# 212437

    Phillip, Australian Capital Territory, 2606

  • Westmead Hospital /ID# 212438

    Westmead, New South Wales, 2145

  • Veracity Clinical Research /ID# 212432

    Woolloongabba, Queensland, 4102

Other trials in Australia

Spain7 sites

  • Hospital General Universitario Alicante /ID# 212010

    Alicante, 03010

  • Hospital Santa Creu i Sant Pau /ID# 212009

    Barcelona, 08041

  • Hospital Universitario Virgen de las Nieves /ID# 212014

    Granada, 18014

  • Hospital General Universitario Gregorio Maranon /ID# 212011

    Madrid, 28007

  • Hospital Universitario Virgen de la Victoria /ID# 212013

    Málaga, 29010

  • Hospital de Manises /ID# 211541

    Manises, Valencia, 46940

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015

    Sabadell, Barcelona, 08208

Other trials in Spain

France6 sites

  • Hopital Prive d'Antony /ID# 212566

    Antony, Île-de-France Region, 92160

  • HCL - Hopital Edouard Herriot /ID# 218408

    Lyon, 69003

  • Chu de Nice-Hopital L'Archet Ii /Id# 212563

    Nice, Alpes-Maritimes, 06200

  • Polyclinique Courlancy /ID# 212567

    Reims, 51100

  • CHU de SAINT ETIENNE - Hopital Nord /ID# 212564

    Saint Priest EN Jarez, Pays de la Loire Region, 42270

  • CHU Toulouse - Hopital Larrey /ID# 213581

    Toulouse, 31400

Other trials in France

Canada5 sites

  • Dr. Irina Turchin PC Inc. /ID# 212248

    Fredericton, New Brunswick, E3B 1G9

  • Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043

    Newmarket, Ontario, L3Y 5G8

  • Dre Angelique Gagne-Henley M.D. inc. /ID# 212249

    Saint-Jérôme, Quebec, J7Z 7E2

  • K. Papp Clinical Research /ID# 212166

    Waterloo, Ontario, N2J 1C4

  • Wiseman Dermatology Research /ID# 212243

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

Japan5 sites

  • Fukuoka University Hospital /ID# 211303

    Fukuoka, Fukuoka, 814-0180

  • Toranomon Hospital /ID# 211742

    Minato-ku, Tokyo, 105-8470

  • Nagoya City University Hospital /ID# 211155

    Nagoya, Aichi-ken, 467-8602

  • University of the Ryukyus Hospital /ID# 211373

    Nakagami-gun, Okinawa, 903-0215

  • Tohoku University Hospital /ID# 212214

    Sendai, Miyagi, 9808574

Other trials in Japan

Germany4 sites

  • Klinikum Ruhr Univ Bochum /ID# 211910

    Bochum, 44791

  • Staedtisches Klinikum Dessau /ID# 211914

    Dessau, 06847

  • Universitaetsklinikum Frankfurt /ID# 211913

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912

    Hamburg, 20246

Other trials in Germany

Netherlands3 sites

  • Bravis Ziekenhuis /ID# 212536

    Bergen op Zoom, North Brabant, 4624 VT

  • Amphia Ziekenhuis /ID# 212538

    Breda, 4818 CK

  • Erasmus Medisch Centrum /ID# 212535

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

About this study

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

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.

Being tested
Risankizumab, Placebo for risankizumab
Keywords
Hidradenitis Suppurativa, Risankizumab, Placebo
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisankizumabDrug

    Also called ABBV-066, SKYRIZI

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

  • Placebo for risankizumabDrug

    Placebo for risankizumab is administered as a SC injection in PFS

Study groups in NCT03926169
Study groupRoleWhat they receive
Risankizumab 180 mgExperimentalIn Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Receives: Drug: Risankizumab
Risankizumab 360 mgExperimentalIn Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Receives: Drug: Risankizumab
PlaceboPlacebo comparatorIn Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
Receives: Drug: Placebo for risankizumab
Risankizumab 180 mg / Risankizumab 360 mgExperimentalIn 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.
Receives: Drug: Risankizumab; Drug: Placebo for risankizumab
Risankizumab 360 mg / Risankizumab 360 mgExperimentalIn 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.
Receives: Drug: Risankizumab; Drug: Placebo for risankizumab
Placebo / Risankizumab 360 mgPlacebo comparatorIn 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.
Receives: Drug: Risankizumab; Drug: Placebo for risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Week 0), Week 16

Secondary outcomes (7)

  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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline (Week 0) to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start3 Jun 2019
  3. Primary completion2 Feb 2021
  4. Study completion2 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03926169
Sponsor's protocol ID
M16-833
Other IDs
2019-000122-21, 2019
Acronym
DETERMINED 1
Status last verified
Jul 2022
First submitted
23 Apr 2019
Last updated
11 Aug 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Kimball AB, Prens EP, Passeron T, Maverakis E, Turchin I, Beeck S, Drogaris L, Geng Z, Zhan T, Messina I, Bechara FG. Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2023 May;13(5):1099-1111. doi: 10.1007/s13555-023-00913-3. Epub 2023 Mar 9.

    PubMed 36892753

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Risankizumab in people with Hidradenitis Suppurativa, run by AbbVie at 59 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Australia, Spain, France, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 (time frame: Baseline (Week 0), Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03926169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.

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