AbbVie Announces Topline Results from the Phase 3 INTREPID Trial Showing Lutikizumab Significantly Improved Signs and Symptoms of Disease in Patients with Hidradenitis Suppurativa

AbbVie plans regulatory submissions in the second half of 2027, supported by additional blinded-extension data expected that year.

Rhea-AI Summary

AbbVie (ABBV) reported that investigational lutikizumab met the primary endpoint in its Phase 3 INTREPID trial for moderate to severe hidradenitis suppurativa. At Week 16, 31.4% versus 23.4% on placebo achieved HiSCR75: at least a 75% reduction in abscesses and inflammatory nodules, without increased abscesses or draining fistulas (p≤0.001).

The trial enrolled 1,400 adults and adolescents and met 8 ranked secondary endpoints. At Week 8, 26.2% versus 15.0% achieved at least a 3-point skin-pain reduction. Flares occurred in 18.4% versus 28.1% over 16 weeks. Overall adverse-event rates were 53.4% versus 53.7%; serious-event rates were 3.0% versus 2.9%. No new safety concerns were identified. AbbVie expects extension data in 2027 to support regulatory submissions in the second half of that year.

12 points · 1 major

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0 major · 2 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointWeek 16 HiSCR75 response reached 31.4% versus 23.4% with placebo, meeting the primary endpoint (p≤0.001).
• Moderate point8 ranked secondary endpoints were met in the Phase 3 INTREPID study.
• Moderate pointWeek 8 skin-pain reduction of at least 3 points occurred in 26.2% versus 15.0% with placebo (p<0.0001).
• Moderate pointWeek 8 skin-pain reduction of at least 30% and 2 units occurred in 36.0% versus 22.8% (p<0.0001).
• Moderate pointHS flares over the first 16 weeks affected 18.4% versus 28.1% with placebo (p<0.0001).
• Moderate pointQuality-of-life measures DLQI and HSIA improved from baseline, with p<0.0001 for each.

6 minor points

• Minor pointIL-17A and IL-17F levels, potential disease drivers, declined over the double-blind 16-week treatment period.
• Minor pointOverall adverse events occurred in 53.4% versus 53.7% with placebo; discontinuation-causing events were 1.7% versus 1.9%.
• Minor pointNo new safety concerns were identified; the safety profile was similar to prior studies.
• Minor pointNo deaths occurred with lutikizumab versus one with placebo; neither group had observed suicidal ideation.
• Minor point. Forward-looking: it has not happened yet and may not happen.2027 extension data are expected to support regulatory submissions in the second half of that year.
• Minor point. Forward-looking: it has not happened yet and may not happen.HS combination-study program is expected to begin later in 2026, evaluating lutikizumab with ABBV-295 and potentially other mechanisms.

Negative

• Minor pointSerious adverse events occurred in 3.0% of lutikizumab patients versus 2.9% with placebo.
• Minor pointCommon treatment-emergent adverse events (≥3%) included nasopharyngitis, upper respiratory tract infections, headache, fatigue and injection-site reactions.

News Explained

AbbVie reports positive Phase 3 topline results, but lutikizumab remains investigational and is not approved by regulatory authorities; the company states that its safety and efficacy have not been established.

Key Figures

HiSCR75 response at Week 16: 31.4% vs 23.4% Ranked secondary endpoints met: 8 NRS3 response at Week 8: 26.2% vs 15.0% +3 more

HiSCR75 response at Week 16

31.4% vs 23.4%

Lutikizumab vs placebo; primary endpoint; p≤0.001

Ranked secondary endpoints met

8

Phase 3 INTREPID study

NRS3 response at Week 8

26.2% vs 15.0%

Lutikizumab vs placebo; p<0.0001

NRS30 response at Week 8

36.0% vs 22.8%

Lutikizumab vs placebo; p<0.0001

Patients experiencing HS flares

18.4% vs 28.1%

Lutikizumab vs placebo during the first 16 weeks; p<0.0001

Patients randomized

1,400

Phase 3 INTREPID study

Key Terms

hiscr75, numeric rating scale (nrs), treatment-emergent adverse event (teae), interleukin (il)

4 terms

hiscr75 medical

"primary endpoint of HiSCR75 at Week 16"

HiSCR75 is a clinical-trial measure used in dermatology that indicates a 75% or greater reduction in the number of painful skin lesions and abscesses compared with baseline. For investors, it is an objective signal of a drug’s effectiveness in reducing disease burden—similar to saying a treatment cuts the symptom load by three-quarters—which can strongly influence regulatory decisions, market adoption and commercial value.

numeric rating scale (nrs) medical

"skin pain on the Numeric Rating Scale (NRS)"

A numeric rating scale (NRS) is a short patient-reported outcome tool that asks a person to quantify the intensity of a symptom (most commonly pain) by choosing a number on a fixed scale, typically 0–10 or 0–100, where the endpoints are defined (for example 0 = no pain, 10 = worst imaginable pain). Respondents pick a single number to represent current, worst, or average symptom intensity; researchers and clinicians use NRS scores to track changes over time or compare groups. The NRS produces ordinal data (numbers show order and direction but not equal intervals), so changes and averages should be interpreted with that limitation in mind and within the specific trial or clinical definitions of meaningful change.

treatment-emergent adverse event (teae) medical

"Overall, treatment-emergent adverse event (TEAE) rates were similar"

A treatment-emergent adverse event (TEAE) is any new or worsening health problem that appears after a patient begins a study drug or medical intervention during a clinical trial. Investors monitor TEAEs like warning lights on a car dashboard: frequent or severe TEAEs can signal safety concerns that may delay or block regulatory approval, require costly additional studies or label restrictions, and ultimately reduce a treatment’s commercial value.

interleukin (il) medical

"dual-variable-domain interleukin (IL) 1α/1β antagonist"

Interleukins (abbreviated IL) are a family of cytokine proteins that immune cells produce to communicate with one another and coordinate immune and inflammatory responses. Each interleukin is given a number (for example, IL-1, IL-6) and has specific effects—such as promoting cell growth, activating or suppressing immune cells, or driving inflammation—so the name refers to a class of related signaling molecules rather than a single substance.

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• In the Phase 3 INTREPID study, lutikizumab achieved the primary endpoint of Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) at Week 16 compared with placebo¹
• Lutikizumab met 8 ranked secondary endpoints, including significant improvements in HS-related skin pain at Week 8 and significant reductions in the occurrence of HS flares over the first 16 weeks,¹ reflecting outcomes assessed by both patients and physicians
• Lutikizumab was generally well tolerated, with no new safety concerns identified¹
• INTREPID provides Phase 3 data supporting the continued investigation of simultaneous inhibition of IL-1α and IL-1β as a potential treatment approach in adults and adolescents with moderate to severe HS¹

NORTH CHICAGO, Ill., Oct. 22, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive topline results from the Phase 3 INTREPID study evaluating the safety and efficacy of lutikizumab, an investigational dual-variable-domain interleukin (IL) 1α/1β antagonist, in adults and adolescents with moderate to severe hidradenitis suppurativa (HS). The study met its primary endpoint and 8 ranked secondary endpoints.

In the INTREPID study, patients treated with lutikizumab achieved significantly higher response rates for the primary endpoint of HiSCR75 at Week 16 compared with placebo (31.4% versus 23.4%; p≤0.001). HiSCR75 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. INTREPID is the first phase 3 study including adults and adolescents with HS to demonstrate statistically significant HiSCR75 response rates at Week 16 as the primary endpoint. 

Lutikizumab also demonstrated statistically significant improvements across key ranked secondary endpoints, including rapid reductions in HS-related pain and significantly fewer HS flares, compared to placebo. At Week 8, 26.2% of patients treated with lutikizumab achieved NRS3, defined as at least a 3-point reduction from baseline in HS-related skin pain on the Numeric Rating Scale (NRS), compared with 15.0% of patients receiving placebo (p<0.0001). Improvements in NRS3 were reported as early as Week 1. In addition, at Week 8, 36.0% of patients receiving lutikizumab achieved NRS30, defined as at least a 30% reduction and at least a 2-unit reduction from baseline in HS-related skin pain, compared with 22.8% of patients receiving placebo (p<0.0001). Lutikizumab also significantly reduced the occurrence of HS flares during the first 16 weeks compared with placebo (18.4% versus 28.1% patients experienced flares; p<0.0001).¹ 

Additional improvements were observed in quality-of-life measures, including changes from baseline in the dermatology life quality index (DLQI) and hidradenitis suppurativa impact assessment (HSIA) (p<0.0001 for each). Key potential disease drivers, including IL-17A and IL-17F levels were also reduced over the double-blind 16-week treatment period. These findings reinforce the potential for lutikizumab to address the burden of disease for people living with moderate to severe HS.

"Elevated levels of IL-1α and IL-1β have been identified in HS lesions, supporting the mechanistic rationale for evaluating lutikizumab in HS. These results further validate our science-led approach and demonstrate how AbbVie applies its deep immunology expertise in our efforts to advance potentially differentiated new treatments grounded in disease biology," said Kori Wallace, M.D., vice president, global head of immunology clinical development, AbbVie. "In addition to achieving the rigorous bar set by HiSCR75, lutikizumab also significantly improved HS-related skin pain and disease flares, reinforcing the importance of an approach to HS that addresses outcomes assessed by both physicians and most importantly, patients."

The safety profile of lutikizumab was similar to prior studies, with no new safety concerns identified. Overall, treatment-emergent adverse event (TEAE) rates were similar with lutikizumab and placebo: any adverse event (AE) (53.4% vs 53.7%), any serious AE (3.0% vs 2.9%), and AEs leading to discontinuation (1.7% vs 1.9%), respectively. The most frequently reported TEAEs associated with lutikizumab (≥ 3%) were nasopharyngitis, upper respiratory tract infections, headache, fatigue, and injection-site reactions. With the exception of injection-site reactions, their rates were similar to placebo. Similar rates of oral candidiasis were also observed between the lutikizumab and placebo groups (0.3% vs 0.4%, respectively). There was no suicidal ideation observed in either the lutikizumab or placebo group. There were no deaths in the lutikizumab group; one death occurred in the placebo group.

"Hidradenitis suppurativa remains an underserved disease and many patients continue to struggle with pain and disease flares despite available therapies," said Alexa B. Kimball, M.D., M.P.H., President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, and Professor of Dermatology at Harvard Medical School. "The INTREPID data are notable because the primary endpoint of HiSCR75 sets a rigorous bar for defining clinical response. These are also the first Phase 3 data evaluating the effect of targeting both IL-1α and IL-1β on this disease. Taken together, these results underscore the promising potential of this investigational treatment."

These data will be presented at a future medical congress. Additional data from the Phase 3 INTREPID study, including results from a 36-week blinded extension period, are expected in 2027 and will be used to support regulatory submissions for lutikizumab in hidradenitis suppurativa in the second half of the year.

These Phase 3 results for lutikizumab reinforce AbbVie's commitment to advancing innovation in hidradenitis suppurativa. Through its HS platform study program, expected to begin later this year, AbbVie plans to evaluate lutikizumab in combination with ABBV-295 (long-acting amylin analog) and potentially other complementary mechanisms, including ABBV-701 (anti-TL1A monoclonal antibody), to address multiple disease pathways that may improve outcomes for patients living with HS.

About the INTREPID Study
INTREPID is a Phase 3 multicenter, randomized, double-blind placebo-controlled study to evaluate the efficacy and safety of lutikizumab in adults and adolescents with moderate to severe hidradenitis suppurativa.² The primary endpoint, achievement of HiSCR75 at Week 16, 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 One of the key secondary endpoints, achievement of NRS30 at Week 8, is defined as at least a 30% reduction and at least a 2-unit reduction from baseline in worst skin pain (maximal daily pain) among subjects with NRS ≥3 at baseline, as assessed by the Patient's Global Assessment (PGA) of HS-related skin Pain NRS.²  Another key secondary endpoint, achievement of NRS3 at Week 8, is defined as at least a 3-unit reduction from baseline in worst skin pain (maximal daily pain) among subjects with NRS ≥3 at baseline, as assessed by the PGA of HS-related skin pain NRS.²  Another key secondary endpoint, occurrence of HS flare during the first 16 weeks, was defined as at least one occurrence of a ≥25% increase in AN count with a minimum absolute increase of 2 relative to baseline.² A total of 1400 patients were randomized, globally, across North America, South America, Europe and Asia, in a 1:1 ratio to lutikizumab SC or placebo. The study consists of three treatment periods: a placebo-controlled Period 1 (baseline to Week 16) to evaluate the efficacy and safety of lutikizumab, a Period 2 (Week 16 to 52) where patients receive blinded lutikizumab, and a 156-week long-term extension Period 3 where all patients continue to receive lutikizumab. The primary and ranked secondary endpoints were evaluated using a prespecified graphical testing approach to control the overall type I error rate. Additional information about the program can be found on clinicaltrials.gov under the identifier NCT06468228.

About Hidradenitis Suppurativa
Hidradenitis suppurativa is a chronic, recurrent, inflammatory and progressive disease that causes irreversible skin damage and disability due to the formation of painful cysts, abscesses and draining fistulas.^3,4,5,6,7 While advances in treatment have been made, limited treatment options are available. Globally, HS affects approximately 1 percent of the population⁸ and can take on average 7-10 years for a person to be diagnosed.^9,10

About Lutikizumab (ABT-981) 
Lutikizumab (ABT-981) is a dual-variable-domain interleukin (IL) 1α/1β antagonist being investigated in HS. Studies have shown that IL-1α and IL-1β are elevated in HS lesions.¹¹ Lutikizumab is an investigational agent and is not approved by regulatory authorities. Safety and efficacy have not been established.

About AbbVie in Immunology
AbbVie is relentless in our pursuit to redefine the standard of care for patients living with immune-mediated conditions, with the goal of helping them live a life free from the limitations of their disease. For almost 30 years, AbbVie has led and helped shape the field of immunology through groundbreaking science and trusted medicines. Building on deep expertise across gastroenterology, rheumatology, dermatology and other areas of high unmet need, we continue to invest in a broad and differentiated pipeline – spanning innovative modalities, novel mechanisms of action and next-generation approaches designed to conquer the complex biology underlying immune-mediated disease.

Today, more than 1 million patients worldwide are treated with AbbVie's immunology medicines, approved in more than 175 countries across 20+ immune-mediated diseases that impact adult and pediatric populations. As we work to strengthen our legacy and drive the next wave of innovation, we remain focused on delivering meaningful progress for patients and expanding access to our medicines. For more information, please visit www.abbvie.com/immunology.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Dr. Kimball is a consultant for AbbVie.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References
¹ AbbVie Data on File ABVRRTI83883.
² A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa (Intrepid). ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT06468228. Accessed September 29, 2026.
³ Negus D, Ahn C, Huang W. An update on the pathogenesis of hidradenitis suppurativa: implications for therapy. Expert Rev Clin Immunol. 2018;14(4):275-283.
⁴ Patel ZS et al. Pain, Psychological Comorbidities, Disability, and Impaired Quality of Life in Hidradenitis Suppurativa [corrected]. Curr Pain Headache Rep. 2017;21(12):49.
⁵ Chen WT, et al. JAMA Dermatol. 2019 Jul 10.
⁶ Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.
⁷ Kimball A, et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. New England Journal of Medicine 375.5; 2016: 422-34.
⁸ Egeberg A, et al. JAMA Dermatol 2016;152:429–34.
⁹ Garg A, et al. JAMA Dermatol. 2018 Jul 1;154(7):814-818.
¹⁰ Saunte DM, et al. Br J Dermatol 2015;173:1546–9.
¹¹ VanderZee et al British Journal of Dermatology (2011) 164, p1292–98; Kanni et al (2015) PLoS ONE 10(6): e0130522.

Media: Olipriya Das, Ph.D. olipriya.das@abbvie.com   Jit Bhowmick, Ph.D. jit.bhowmick@abbvie.com

Investors: Liz Shea liz.shea@abbvie.com

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SOURCE AbbVie

FAQ

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What did AbbVie's Phase 3 INTREPID trial show for lutikizumab?

Lutikizumab met the primary endpoint, with 31.4% achieving HiSCR75 at Week 16 versus 23.4% with placebo (p≤0.001). HiSCR75 requires at least a 75% reduction in abscesses and inflammatory nodules, without increased abscesses or draining fistulas. The study also met 8 ranked secondary endpoints.

When does AbbVie plan regulatory submissions for lutikizumab in hidradenitis suppurativa?

AbbVie plans regulatory submissions in the second half of 2027, supported by additional INTREPID data expected in 2027. Those data include results from a 36-week blinded extension period.

How was AbbVie's INTREPID lutikizumab study designed?

INTREPID randomized 1,400 adults and adolescents with moderate to severe hidradenitis suppurativa in a 1:1 ratio to subcutaneous lutikizumab or placebo. The study includes a placebo-controlled period through Week 16, blinded lutikizumab treatment from Weeks 16 to 52, and a 156-week long-term extension in which all patients continue lutikizumab.

Which combinations does AbbVie plan to study with lutikizumab for hidradenitis suppurativa?

AbbVie plans to evaluate lutikizumab with ABBV-295, a long-acting amylin analog, and potentially other complementary mechanisms, including ABBV-701, an anti-TL1A monoclonal antibody. The HS platform study program is expected to begin later in 2026.