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Cleaver Medical Group Dermatology | Dawsonville, GA

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A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa (Intrepid)

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AbbVie

Status and phase

Enrolling
Phase 3

Conditions

Hidradenitis Suppurativa

Treatments

Drug: Lutikizumab
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06468228
M20-465
2024-510730-40-00 (Other Identifier)

Details and patient eligibility

About

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. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with moderate to severe HS .

Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms.

In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 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.

Enrollment

1,280 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant).
  • Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline
  • Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline.
  • At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.

Exclusion criteria

  • Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  • Confirmed positive anti-HIV antibody (HIV Ab) test.
  • Evidence of active tuberculosis or meets tuberculosis exclusionary parameter

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,280 participants in 6 patient groups

Period 1
Experimental group
Description:
Participants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 .
Treatment:
Drug: Placebo
Drug: Lutikizumab
Period 2: Lutikizumab Every Week
Experimental group
Description:
Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52
Treatment:
Drug: Lutikizumab
Period 2: Lutikizumab Every Other Week
Experimental group
Description:
Participants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52
Treatment:
Drug: Placebo
Drug: Lutikizumab
Period 2: Placebo to Lutikizumab Group
Experimental group
Description:
Participants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week.
Treatment:
Drug: Lutikizumab
Period 2: Placebo to Lutikizumab Group Every Week
Experimental group
Description:
Participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52
Treatment:
Drug: Lutikizumab
Period 2: Placebo to Lutikizumab Group Every Other Week
Experimental group
Description:
The participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52
Treatment:
Drug: Placebo
Drug: Lutikizumab

Trial contacts and locations

89

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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