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NCT05139602 · ClinicalTrials.gov registry record · Phase 2

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 and Who Are Naïve to Biologic Therapy

A Phase 2 study of Hidradenitis Suppurativa, sponsored by AbbVie.

Active
Registry status
Phase 2
Development phase
210
Enrollment target
20
Study locations

NCT05139602 is a Phase 2 study of Hidradenitis Suppurativa that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 210 participants, below the 594-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT05139602, a Phase 2 study of Hidradenitis Suppurativa, is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
210 participants
Enrollment target
20
Study locations

Study 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. In the Main Study, 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. In the Sub-study, participants will be put in 1 of 2 groups, called treatment arms. Both arms will receive treatment at different dosing intervals. Around 40 adult participants with moderate to severe HS who are naïve to biologic therapy will be enrolled in the study at approximately 20 sites. In the Main Study, participants will receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks. In the Sub-study, participants will receive subcutaneous injections of lutikizumab (ABT-981) every week for the first 15 weeks, then either every week or every other week for 36 weeks. There will be an optional Long Term Extension (LTE) for participants who completed Week 52 of the Sub-study and, as confirmed by the investigator, have shown a therapeutic benefit to study drug. Participants would then received lutikizumab using the same assigned dosing regimen as that from Period 2 of the Sub-study for an additional 104 weeks. There may be hi

Conditions Studied

Hidradenitis Suppurativa

Interventions

  • DRUG Placebo
  • BIOLOGICAL Lutikizumab

Study Locations (20)

Florida

  • Skin Care Research Boca Raton /ID# 240758 - Boca Raton
  • Apex Clinical Trials /ID# 248558 - Brandon
  • GSI Clinical Research, LLC /ID# 240901 - Margate
  • Florida International Rsrch cr /ID# 240902 - Miami
  • Park Avenue Dermatology, PA /ID# 240807 - Orange Park
  • Duplicate_TruDerm Dermatology of Wellington /ID# 240780 - Wellington

California

  • UCSF Fresno /ID# 240903 - Fresno
  • Medderm Associates /ID# 240729 - San Diego
  • Clinical Trials Research Institute /ID# 240642 - Thousand Oaks

Arizona

  • Medical Dermatology Specialists /ID# 240641 - Phoenix
  • Mayo Clinic - Scottsdale /ID# 241030 - Scottsdale

Missouri

  • MediSearch Clinical Trials /ID# 240810 - Saint Joseph
  • Washington University-School of Medicine /ID# 240797 - St Louis

Nebraska

  • Advanced Dermatology of the Midlands /ID# 249750 - Omaha
  • Duplicate_Skin Specialists, PC /ID# 240804 - Omaha

Arkansas

  • Burke Pharmaceutical Research /ID# 240811 - Hot Springs

Connecticut

  • CCD Research, PLLC /ID# 240728 - Cromwell

Indiana

  • Dawes Fretzin, LLC /ID# 240701 - Indianapolis

Trial Details

FieldValue
Enrollment Target 210 participants
Start Date 2021-12-28
Est. Completion 2027-12
Phase Phase 2

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05139602

The ClinicalTrials.gov registry entry for NCT05139602 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 594-participant average among 52 other Hidradenitis Suppurativa trials with a reported enrollment target (65% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hidradenitis Suppurativa appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05139602 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Arizona.

Frequently Asked Questions

What is clinical trial NCT05139602 about?

NCT05139602 is a clinical study titled "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 and Who Are Naïve to Biologic Therapy". 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 (TN...

What is the current status of trial NCT05139602?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2021-12-28. Estimated completion is 2027-12.

What conditions does trial NCT05139602 study?

This clinical trial studies the following conditions: Hidradenitis Suppurativa.

What interventions are being tested in trial NCT05139602?

The interventions under investigation include: Placebo (DRUG), Lutikizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT05139602?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05139602 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.