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NCT Number: NCT06468228

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

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 the signs and symptoms of 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.

Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks.

Participants in the US that complete Periods 1 & 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consultorios Reumatologicos Pampa /ID# 265911, Ciudad Autonoma de Buenos Aire, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lutikizumab

Drug

Subcutaneous injection

Other names: ABT-981

Placebo

Drug

Subcutaneous injection

Primary outcomes

  1. Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75

    Time frame: At Week 16

    HiSCR 75 is defined as at least a 75% 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.

  2. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Approximately Week 62

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary outcomes

  1. Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3

    Time frame: At Week 8

    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.

  2. Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline

    Time frame: At Week 16

    DLQI (Dermatology Life Quality Index) assesses symptoms and impacts of dermatologic diseases on quality of life. DLQI scores range from 0 (no effect) to 30 (very large effect), with a higher score indicating a more impaired quality of life.

  3. Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)

    Time frame: At Week 16

    The HSIA is an 18-item PRO questionnaire developed to assess the impact of HS on the daily lives of subjects in the 7 days prior to the assessment. Items 1 - 16 of the HSIA are scored on a 0 to 10 NRS, where 0 represents no impact and 10 represents extreme impact.

  4. Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score

    Time frame: At Week 16

    The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of Hidradenitis Suppurativa (HS) in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

  5. Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline

    Time frame: At Week 16

  6. Percentage of Participants Achieving HiSCR 90

    Time frame: At Week 16

    HiSCR 90 is defined as at least a 90% 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.

  7. Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS)

    Time frame: At Week 8

  8. Change from Baseline in HSSA

    Time frame: At Week 16

    The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of Hidradenitis Suppurativa (HS) in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

  9. Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8

    Time frame: At Week 16

    The HSSA (24-hour recall) is a 9-item PRO questionnaire developed to assess the primary symptoms of HS in the 7 consecutive days prior to assessments. Each item of the HSSA is scored on an 11-point (0 to 10) NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.

  10. Percentage of Participants with an Occurrence of HS Flare in Period 1

    Time frame: Baseline to Week 16

    HS Flare is defined as at least one occurrence of a ≥ 25% increase in AN count with a minimum absolute increase of 2 relative to Baseline.

  11. Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Emotional Domain

    Time frame: At Week 16

  12. Change from Baseline in HSIA Mobility Domain

    Time frame: at Week 16

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects With Moderate to Severe Hidradenitis Suppurativa

Acronym: Intrepid

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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