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Monoclonal Antibodies

Lutikizumab for Hidradenitis Suppurativa

Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have failed anti-TNF treatment for HS
HS lesions present in at least 2 distinct anatomic areas
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately week 68
Awards & highlights

Study Summary

This trial will compare the investigational drug lutikizumab (ABT-981) to placebo to see if it is effective in treating HS in people who have not responded to anti-TNF therapy.

Who is the study for?
Adults with moderate to severe Hidradenitis Suppurativa (HS) who didn't get better with anti-TNF therapy can join. They must have at least 5 abscesses and nodules in two different body areas, been diagnosed with HS for a year or more, and not tried biologic treatments yet.Check my eligibility
What is being tested?
The trial is testing Lutikizumab (ABT-981), an experimental drug, against a placebo. Participants will be randomly assigned to receive either the drug or placebo through weekly injections for up to 16 weeks in the main study, and possibly longer in a sub-study.See study design
What are the potential side effects?
Possible side effects of Lutikizumab are not detailed here but may include reactions at the injection site, increased risk of infections due to immune system suppression, and other immune-related conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have tried anti-TNF treatment for HS without success.
Select...
I have HS lesions in at least two different body areas.
Select...
I have not used biologic therapy for my HS condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately week 68
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately week 68 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Adverse Events (AEs)
Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)
Secondary outcome measures
Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Sub-study: Group 2Experimental Treatment1 Intervention
Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.
Group II: Sub-study: Group 1Experimental Treatment1 Intervention
Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.
Group III: Main Study: Lutikizumab Dose CExperimental Treatment1 Intervention
Lutikizumab Dose C every other week
Group IV: Main Study: Lutikizumab Dose BExperimental Treatment1 Intervention
Lutikizumab Dose B every other week
Group V: Main Study: Lutikizumab Dose AExperimental Treatment1 Intervention
Lutikizumab Dose A every week
Group VI: Main Study: PlaceboPlacebo Group1 Intervention
Placebo every week

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,190 Total Patients Enrolled
11 Trials studying Hidradenitis Suppurativa
2,748 Patients Enrolled for Hidradenitis Suppurativa
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,909 Total Patients Enrolled
4 Trials studying Hidradenitis Suppurativa
1,685 Patients Enrolled for Hidradenitis Suppurativa

Media Library

Lutikizumab (ABT-981) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05139602 — Phase 2
Hidradenitis Suppurativa Research Study Groups: Main Study: Lutikizumab Dose A, Main Study: Lutikizumab Dose C, Main Study: Placebo, Sub-study: Group 1, Sub-study: Group 2, Main Study: Lutikizumab Dose B
Hidradenitis Suppurativa Clinical Trial 2023: Lutikizumab (ABT-981) Highlights & Side Effects. Trial Name: NCT05139602 — Phase 2
Lutikizumab (ABT-981) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139602 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment process still open for participants in this trial?

"Affirmative. According to the information displayed on clinicaltrials.gov, this medical trial is currently recruiting patients; it was posted on December 28th 2021 and last updated November 7th 2022. The project requires 160 participants from 39 different sites for completion."

Answered by AI

Is this the inaugural endeavor of its kind?

"AbbVie is the sponsor for the single existing Lutikizumab study, which was first conducted in 2021 and has since involved 16,327 participants across 8 countries. At present, 51 cities are participating in this Phase 2 drug approval trial."

Answered by AI

Have any additional research projects focused on Lutikizumab been conducted?

"Lutikizumab was first tested at UC Davis Health /ID# 240725 in 2021, and with 18327 trials completed to date, there is presently one active trial being conducted from Seattle, Washington."

Answered by AI

Has the regulatory agency sanctioned Lutikizumab for public use?

"Our team at Power evaluated the safety of Lutikizumab to be a 2 since this is an early-stage clinical trial, with evidence validating its security but no data assessing its efficacy."

Answered by AI

Are there ample healthcare facilities executing this experiment across North America?

"This research initiative is actively recruiting participants from various medical centres, including Dermatology Associates of Seattle /ID# 250731 in Seattle, Washington; GSI Clinical Research, LLC /ID# 240901 in Margate, Florida; and Skin care Research - Boca Raton /ID# 240758 located in New york. Moreover 39 additional sites are also accepting patient enrolment."

Answered by AI

How many participants are partaking in this medical experiment?

"In order for the AbbVie sponsored investigation to launch, 160 patients that meet all criteria must be found. The two sites chosen are Dermatology Associates of Seattle (ID# 250731) located in Seattle, Washington and GSI Clinical Research LLC (ID# 240901) based out of Margate, Florida."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
California
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Medical Dermatology Specialist /ID# 240641
UC Davis Health /ID# 240725
Center for Clinical Studies - Houston (Binz) /ID# 240692
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Center for Clinical Studies - Houston (Binz) /ID# 240692: < 48 hours
Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05139602.
All > Hidradenitis Suppurativa
~83 spots leftby Jan 2026
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