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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    160
  • sponsor
    AbbVie
Updated on 27 October 2022
Investigator
AbbVie_Call Center
Primary Contact
Beacon Dermatology Inc /ID# 240741 (2.8 mi away) Contact
+46 other location
abscess

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.

Details
Condition Hidradenitis Suppurativa
Treatment Placebo, Lutikizumab
Clinical Study IdentifierNCT05139602
SponsorAbbVie
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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