Lutikizumab for Hidradenitis Suppurativa

Recruiting at 78 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AbbVie

Must be taking: Anti-TNF

Disqualifiers: Active skin disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

210 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, you must have failed anti-TNF treatment for HS to be eligible.

How is the drug Lutikizumab different from other treatments for hidradenitis suppurativa?

Lutikizumab is unique because it targets specific inflammatory pathways by inhibiting interleukin-1, which is different from other treatments like adalimumab that target tumor necrosis factor-alpha. This novel approach may offer an alternative for patients who do not respond to existing therapies. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new drug called lutikizumab to help adults with a painful skin condition called hidradenitis suppurativa (HS) who haven't been helped by other treatments. The drug works by reducing inflammation in the skin.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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.

Inclusion Criteria

I have tried anti-TNF treatment for HS without success.

I have HS lesions in at least two different body areas.

Total abscess and inflammatory nodule (AN) count of >= 5 at Baseline

Exclusion Criteria

I have no active skin conditions that could affect HS assessment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment (Main Study)

Participants receive subcutaneous injections of lutikizumab (ABT-981) or placebo every week for 16 weeks

16 weeks

Weekly visits (in-person)

Treatment (Sub-study)

Participants 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

51 weeks

Weekly or bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long Term Extension (optional)

Participants who completed Week 52 of the Sub-study and have shown a therapeutic benefit may continue treatment for an additional 104 weeks

104 weeks

Treatment Details

Interventions

• Lutikizumab (ABT-981)

Trial Overview 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.

Participant Groups

Group I: Sub-study: Group 2 Experimental Treatment 1 Intervention

Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.

Group II: Sub-study: Group 1 Experimental Treatment 1 Intervention

Period 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.

Group III: Main Study: Lutikizumab Dose C Experimental Treatment 1 Intervention

Lutikizumab Dose C every other week

Group IV: Main Study: Lutikizumab Dose B Experimental Treatment 1 Intervention

Lutikizumab Dose B every other week

Group V: Main Study: Lutikizumab Dose A Experimental Treatment 1 Intervention

Lutikizumab Dose A every week

Group VI: Main Study: Placebo Placebo Group 1 Intervention

Placebo every week

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a phase II study involving 243 patients with moderate-to-severe hidradenitis suppurativa (HS), risankizumab did not meet the primary endpoint of achieving HS Clinical Response (HiSCR) at week 16, indicating it may not be an effective treatment for this condition.

The safety profile of risankizumab was generally favorable, with low rates of treatment-emergent adverse events across all treatment groups, suggesting that while it may not be effective, it is also not associated with significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. Kimball, AB., Prens, EP., Passeron, T., et al.[2023]

A patient with hidradenitis suppurativa (HS) initially responded well to infliximab, a TNF-alpha antagonist, but experienced an infusion reaction, highlighting the potential for adverse effects with certain treatments.

Switching to adalimumab, another TNF-alpha inhibitor, resulted in significant and sustained improvement in the patient's condition for over 15 months, suggesting that adalimumab is a safe and effective alternative for patients who cannot tolerate infliximab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Recalcitrant Hidradenitis Suppurativa with Adalimumab. Gorovoy, I., Berghoff, A., Ferris, L.[2021]

Adalimumab, a treatment for Crohn's disease, has recently been approved for hidradenitis suppurativa, but in this case, it paradoxically triggered the onset of hidradenitis suppurativa in a 40-year-old woman.

This case highlights the potential for unexpected side effects of medications, even those that are effective for other conditions, emphasizing the need for careful monitoring in patients receiving adalimumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa in Crohn's disease during adalimumab therapy: a paradox? Martina, E., Campanati, A., Giuliodori, K., et al.[2019]

In adult patients with hidradenitis suppurativa (HS), adalimumab reaches steady serum concentrations of 10-12 µg/mL by week 2 and maintains these levels through week 12, indicating effective dosing.

The development of anti-adalimumab antibodies (AAA) was low (10% in phase II and 7% in phase III studies), but the presence of AAA was associated with decreased drug concentrations, which could potentially reduce the treatment's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Immunogenicity of Adalimumab in Adult Patients with Moderate-to-Severe Hidradenitis Suppurativa. Nader, A., Beck, D., Noertersheuser, P., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Successful Treatment of Recalcitrant Hidradenitis Suppurativa with Adalimumab. [2021]

3. Australia pubmed.ncbi.nlm.nih.gov

Moderate to severe hidradenitis suppurativa treated with biological therapies. [2015]

4. Slovenia pubmed.ncbi.nlm.nih.gov

Hidradenitis suppurativa in Crohn's disease during adalimumab therapy: a paradox? [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Immunogenicity of Adalimumab in Adult Patients with Moderate-to-Severe Hidradenitis Suppurativa. [2018]