NCT05139602

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

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.

Interventional study

Status:
Recruiting
Conditions:
Hidradenitis Suppurativa
Enrollment:
160 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M20-262
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

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.

All the cities where the clinical studies are located

Calgary - T3E 0B2
Newmarket - L3Y 5G8
Saint-Jerome - J7Z 7E2
Winnipeg - R3M 3Z4

More information about this study

clinicaltrials.gov