Lutikizumab for Hidradenitis Suppurativa

Not currently recruiting at 86 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of lutikizumab, an investigational drug, for individuals with hidradenitis suppurativa (HS), a painful skin condition that causes lumps and scars. It targets those who have tried anti-TNF therapy for HS without sufficient relief. Participants will be divided into groups to compare lutikizumab with a placebo (a non-active substance) and to test different dosing schedules. Suitable candidates have had HS for over a year, have lumps in at least two body areas, and have not benefitted from previous anti-TNF treatment. Participants should expect regular hospital or clinic visits for evaluations and side effect monitoring. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to potential advancements in HS treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lutikizumab, tested on patients with moderate to severe hidradenitis suppurativa (HS), demonstrates promising safety results. In one study, patients receiving lutikizumab weekly or every other week experienced improved skin conditions without major safety issues. The trials assessed side effects and found the treatment generally well-tolerated.

Some participants experienced mild to moderate side effects, similar to those from other treatments. It is important to note that lutikizumab remains under study, and ongoing research will continue to provide more safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Lutikizumab for treating Hidradenitis Suppurativa because it offers a different approach compared to existing treatments like antibiotics, anti-inflammatory drugs, or biologics such as adalimumab. Unlike these treatments, Lutikizumab is an antibody that specifically targets and neutralizes interleukin-1 alpha and beta, proteins involved in inflammation. This targeted mechanism could potentially reduce inflammation more effectively and with fewer side effects. Additionally, the trial explores various dosing schedules, offering flexibility that might better suit individual patient needs.

What evidence suggests that this trial's treatments could be effective for hidradenitis suppurativa?

Research has shown that lutikizumab may help treat hidradenitis suppurativa (HS). In this trial, participants will receive different doses of lutikizumab, either weekly or every other week, or a placebo. Earlier studies found that patients who took lutikizumab weekly or every other week experienced less skin pain and fewer symptoms than those who did not. Specifically, these patients had more success in reducing skin pain and other HS symptoms. Lutikizumab also improved draining tunnels, which are common and painful in HS. These results suggest that lutikizumab could be a good treatment option for people with moderate to severe HS, especially if other treatments have not worked for them. ^{1 3 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrialsarena.com clinicaltrialsarena.com/news/abbvie-trial-lutikizumab/

AbbVie reports data from trial of hidradenitis suppurativa drug According to the findings, subjects who received 300mg of lutikizumab weekly or every other week demonstrated significantly higher response ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-922

A Study to Assess Molecular Changes in Adult Participants ... Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD. This study will consist of 2 sub-studies: Sub-Study 1 moderate ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05139602

NCT05139602 | A Study to Assess Disease Activity and ... A Study to Assess Disease Activity and Safety of Subcutaneous Lutikizumab (ABT-981) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa Who ...

4. news.abbvie.com news.abbvie.com/2024-01-08-Lutikizumab-Showed-Positive-Results-in-a-Phase-2-Trial-of-Adults-with-Moderate-to-Severe-Hidradenitis-Suppurativa-as-Program-Advances-to-Phase-3

Lutikizumab Showed Positive Results in a Phase 2 Trial of ... Patients receiving lutikizumab 300 mg weekly and 300 mg every other week achieved higher rates of improved skin pain via NRS30 and HiSCR75, a higher threshold ...

5. jaad.org jaad.org/article/S0190-9622(25)00962-4/fulltext

63539 Improvement in Draining Tunnels in Response to ... Conclusion: In this hard-to-treat HS patient population, treatment with lutikizumab resulted in greater numerical improvements in dTs than placebo. Article ...

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M20-465

A Study to Assess Disease Activity and Safety of ... A study to assess disease activity and safety of Lutikizumab in adult and adolescent participants with moderate to severe hidradenitis Suppurativa.

7. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M20-262

M20-262 A study to assess disease activity and safety of subcutaneous Lutikizumab (ABT-981) in adult participants with moderate to severe hidradenitis Suppurativa.