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A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-Tumor Necrosis Factor (TNF) Therapy

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ClinicalTrials.gov Identifier: NCT05139602
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. Despite the clinical benefit anti-tumor necrosis factor (TNF) therapy offers to patients with HS, there remains a significant unmet medical need for patients who fail to achieve adequate benefit with anti-TNF therapy. This study will compare lutikizumab (ABT-981) versus placebo for the treatment of adult participants with moderate to severe HS who have failed anti-TNF therapy.

Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS. Participants will be put in 1 of 4 groups, called treatment arms. There is a 1 in 4 chance that participants will be assigned to placebo. Around 160 adult participants with moderate to severe HS who have failed anti-TNF therapy will be enrolled in the study at approximately 50 sites worldwide.

Participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries.


Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Biological: Lutikizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lutikizumab (ABT-981) in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : October 22, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lutikizumab Dose A
Lutikizumab Dose A every week
Biological: Lutikizumab
Subcutaneous Injection
Other Name: ABT-981

Experimental: Lutikizumab Dose B
Lutikizumab Dose B every other week
Biological: Lutikizumab
Subcutaneous Injection
Other Name: ABT-981

Experimental: Lutikizumab Dose C
Lutikizumab Dose C every other week
Biological: Lutikizumab
Subcutaneous Injection
Other Name: ABT-981

Placebo Comparator: Placebo
Placebo every week
Drug: Placebo
Subcutaneous Injection




Primary Outcome Measures :
  1. Percentage of Participants Achieving Hidradenitis Suppurative 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 count and no increase in draining fistula-count relative to Baseline.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3 [ Time Frame: Week 16 ]
    NRS 30 is defined as at least a 30% reduction and at least 1-unit reduction from Baseline in worst skin pain (maximal daily pain), as assessed by the Patient's Global Assessment (PGA) of Skin Pain.



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of hidradenitis suppurativa (HS) for at least 1 year prior to Baseline as determined by the investigator.
  • A total abscess and inflammatory nodule (AN) count of >= 5 at Baseline
  • HS lesions must be present in at least 2 distinct anatomic areas.
  • Must have failed anti-TNF treatment for HS.

Exclusion Criteria:

- History of active skin disease other than HS that could interfere with the assessment of HS, including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline visit.


Information from the National Library of Medicine

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): NCT05139602


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
Show Show 55 study locations
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05139602    
Other Study ID Numbers: M20-262
2020-004108-33 ( EudraCT Number )
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
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, analyses plans, 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: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
URL: https://vivli.org/ourmember/abbvie/

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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.: Yes
Keywords provided by AbbVie:
Hidradenitis Suppurativa
Lutikizumab
ABT-981
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration