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ABT-981

Phase 3

Erosive Hand Osteoarthritis | Monoclonal antibody | Musculoskeletal |AbbVie Inc.|Trials Updated: Oct 8, 2026

ABT-981 development status

Highest phase Phase 3 (NCT06468228)
Phase scored for ABBVPhase 2
Registered trials 11 across 2 sponsors since Aug 2012

ABT-981 target and mechanism

Molecular targetIL 1α/1β
Target classInterleukin Antagonist
ModalityMonoclonal antibody

Also known as lutikizumab

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials10
Total Enrollment2,727

FDA Designations

No designations recorded

ABT-981 clinical trials

ABT-981 · 10 trials · 9 indications

Phase 3 1Phase 2 8Phase 1 1
NCT06468228A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis Suppurativa
ACTIVE NOT_RECRUITING1,400 Analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Hidradenitis SuppurativaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75
At Week 16

HiSCR 75 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.

Number of Participants with Adverse Events (AEs)
Up to Approximately Week 62

An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
At Week 12

Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: 1. ≥ 50% improvement in 68-tender joint count; 2. ≥ 50% improvement in 66-swollen joint count; and 3. ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Health Assessment Questionnaire - Disability Index (HAQ-DI) * High-sensitivity C-reactive protein (hsCRP)

Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16
At Week 16

EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

Percentage of Participants Who Reported Adverse Events
Up to Week 52

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Percentage of Participants who Achieve Endoscopic Improvement
Week 12

Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR)
Week 16

HiSCR is defined as at least a 50% 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.

Australian/Canadian Hand Osteoarthritis Index (AUSCAN NR3.1) Pain Subdomain Score: Change From Baseline to Week 16
Week 0 (Baseline), Week 16

The AUSCAN NR3.1 is a self-report measure composed of a battery of 15 questions assessing the three dimensions of pain (5 questions), joint stiffness (1 question) and physical function (9 questions) using an 11-box Numerical Rating Scale (NRS-11) from 0 (low) to 10 (high). The pain subdomain score ranges from 0 to 50; lower scores indicate better status. A decrease in the pain subdomain score represents improvement in status. Last Observation Carried Forward (LOCF): Missing responses were imputed by calculation based on the last nonmissing postbaseline component values.

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scores of the Index Knee at Week 16
Baseline, Week 16

The WOMAC was developed to assess pain, stiffness, and physical function in subjects with hip and/or knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items); Stiffness (2 items); and Physical Function (17 items). Each item is rated on an 11-point (0 to 10) numerical rating scale (NRS). The pain sub-score has a range of 0 (no pain) to 50 (maximum pain). A negative change from baseline indicates improvement.

Change From Baseline in Quantitative Synovitis of the Index Knee at Week 26
Baseline, Week 26

Change in synovitis of the index knee was evaluated using quantitative magnetic resonance imaging (MRI) measurements. MRI quantitative synovitis of the index knee was defined by mean synovial membrane thickness.

Change From Baseline in Effusion Volume of the Index Knee at Week 26
Baseline, Week 26
Change From Baseline in Whole-Organ Magnetic Resonance Imaging Score (WORMS) Semi-Quantitative Synovitis/Effusion Score of the Index Knee at Week 26
Baseline, Week 26

Semi-quantitative synovitis/effusion volume WORMS scores were scored as normal (0), \< 33% of maximum estimated distention (1), 33% - 66% of maximum estimated distention (2), or \> 66% of maximum estimated distention (3).

Number of participants with Adverse Events
From date of first dose of ABT-981 until 70 days after the last dose of ABT-981

Collect all adverse events at each visit

Physical Exam including vital signs
From date of first dose of ABT-981 until 70 days after last dose of ABT-981

Blood pressure, heart rate and body temperature

Clinical Lab Testing
From date of first dose of ABT-981 until 70 days after the last dose of ABT-981

Hematology, Chemistry, and Urinalysis

Change from Baseline in Electrocardiogram (ECG)
Prior to dose and 8 hours post dose on each day of dosing

ECGs done in triplicate

Maximum observed serum concentration (Cmax) of ABT-981
Prior to first dose up to 70 days after the last dose of ABT-981

Cmax

Time to Cmax (Tmax) of ABT-981
Prior to first dose up to 70 days after the last dose of ABT-981

Time to Cmax

The area under the time curve (AUC) of ABT-981
Prior to first dose up until 70 days after the last dose of ABT-981

AUC

The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-981
Prior to the last dose up to 70 days after the last dose of ABT-981

Secondary Endpoints

Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3
At Week 8
Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline
At Week 16
Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)
At Week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Period 1EXPERIMENTALParticipants will be randomized to either Lutikizumab Dose B at baseline followed by Lutikizumab Dose A, or a matching placebo dose equivalent for both, every week through Week 16 .
Period 2: Lutikizumab Every WeekEXPERIMENTALParticipants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A through Week 52
Period 2: Lutikizumab Every Other WeekEXPERIMENTALParticipants randomized to lutikizumab in Period 1 who complete Week 16 of the study will be re-randomized to lutikizumab Dose A every other week though week 52
Period 2: Placebo to Lutikizumab GroupEXPERIMENTALParticipants randomized to Placebo in Period 1 who complete Week 16 of the study will initiate lutikizumab with Dose B followed by Dose A every week.
Period 2: Placebo to Lutikizumab Group Every WeekEXPERIMENTALParticipants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every week through Week 52
Period 2: Placebo to Lutikizumab Group Every Other WeekEXPERIMENTALThe participants that were assigned Placebo in Period 1 and initiated lutikizumab in Period 2 will then be re-randomized to lutikizumab Dose A every other week through Week 52
Period 3: Open-label LutikizumabEXPERIMENTALStarting at Week 68 in Period 3, all participants will receive Open-label Lutikizumab every other week
Sub-Study: Lutikizumab Pre-Filled PenEXPERIMENTALLutikizumab solution for injection in prefilled pen (EOW) for 60 weeks, followed by lutikizumab solution for injection in prefilled syringes (EOW) for 96 weeks.
Substudy 1: Lutikizumab MonotherapyEXPERIMENTALParticipants will be randomized to initially receive Lutikizumab Dose A followed by Lutikizumab Dose B
Substudy 1: Matching Placebo MonotherapyPLACEBO_COMPARATORParticipants will be randomized to receive a matching placebo dose equivalent to the Lutikizumab monotherapy.
Substudy 2: Ravagalimab MonotherapyEXPERIMENTALParticipants will be randomized to receive Ravagalimab
Substudy 2: Matching Placebo MonotherapyPLACEBO_COMPARATORParticipants will be randomized to receive a matching placebo dose equivalent to the Ravagalimab monotherapy
SubStudy 3: Lutikizumab and Ravagalimab Combination TherapyEXPERIMENTALParticipants will be randomized to be administered Lutikizumab and Ravagalimab doses
Substudy 3: Matching Placebo Combination TherapyPLACEBO_COMPARATORParticipants will be randomized to receive matching placebo doses equivalent to the Lutikizumab and Ravagalimab combination therapy
Sub-Study 1: Risankizumab MonotherapyEXPERIMENTALParticipants will receive Risankizumab
Sub-Study 1: Lutikizumab MonotherapyEXPERIMENTALParticipants will initially receive Lutikizumab Dose A followed by Lutikizumab Dose B every other week.
SubStudy 1: Lutikizumab and Risankizumab Combination TherapyEXPERIMENTALParticipants will be administered Lutikizumab and Risankizumab at the same time following the same dosing regimen as the monotherapy arms.
Substudy 1: Placebo to LutikizumabEXPERIMENTALIn Period 1, participants will be receive a matching placebo Dose A at Baseline randomization, followed by matching placebo Dose B every other week starting at Week 2 for 16 weeks. At Week 16, participants that were assigned placebo will then enter Period 2 and receive open-label lutikizumab Dose A, followed by lutikizumab Dose B every other week starting at Week 18, and lutikizumab Dose C every other week starting at Week 32 until Week 52.
SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-NaïveEXPERIMENTALHS Bio-naïve participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration, with the option to enter an open-label LTE to continue to receive Lutikizumab Dose B at Week 16 and every week thereafter.
SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate ResponseEXPERIMENTALTumor Necrosis Factor-Inadequate Response (TNF-IR) participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration.
SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïveEXPERIMENTALAD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR)EXPERIMENTALAD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
Induction Group 1EXPERIMENTALParticipants will receive Dose 1 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.
Induction Group 2EXPERIMENTALParticipants will receive Dose 2 of IV lutikizumab at Baseline followed by SC lutikizumab throughout induction.
Induction Group 3EXPERIMENTALParticipants will receive adalimumab per label throughout induction.
Maintenance Group 1EXPERIMENTALParticipants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period.
Maintenance Group 2EXPERIMENTALParticipants who responded to lutikizumab induction group 1 or 2 will be re-randomized. Participants in this group will receive SC lutikizumab throughout the maintenance period.
Maintenance AdalimumabEXPERIMENTALParticipants who respond to adalimumab induction group 3 will continue to receive adalimumab per label in the maintenance period.
Maintenance Non-RespondersEXPERIMENTALParticipants who do not respond to study drug at the end of induction period will receive SC lutikizumab in the maintenance period.
Optional Long-Term Extension (LTE)EXPERIMENTALParticipants who complete the maintenance period, are willing/able to inject study drug at home, and in whom therapeutic benefit to study drug is confirmed by the investigator, may participate in the optional 52-week LTE.
Main Study: Lutikizumab Dose AEXPERIMENTALLutikizumab Dose A every week
Main Study: Lutikizumab Dose BEXPERIMENTALLutikizumab Dose B every other week
Main Study: Lutikizumab Dose CEXPERIMENTALLutikizumab Dose C every other week
Main Study: PlaceboPLACEBO_COMPARATORPlacebo every week
Sub-study: Group 1EXPERIMENTALPeriod 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every week.
Sub-study: Group 2EXPERIMENTALPeriod 1: Lutikizumab Dose A every week. Period 2: Lutikizumab Dose A every other week.
PlaceboPLACEBO_COMPARATORPlacebo for ABT-981 every two weeks (Q2W) for 24 weeks.
ABT-981EXPERIMENTALABT-981 200 mg every two weeks (Q2W) for 24 weeks.
ABT-981 low doseEXPERIMENTAL25 mg ABT-981 subcutaneous (SC) every 2 weeks (E2W)
ABT-981 medium doseEXPERIMENTAL100 mg ABT-981 SC E2W
ABT-981 high doseEXPERIMENTAL200 mg ABT-981 SC E2W
Group 1EXPERIMENTALRandomized 7 drug/2 placebo by group
Group 2EXPERIMENTALRandomized 7 drug/2 placebo by group
Group 3EXPERIMENTALRandomized 7 drug/2 placebo by group
Group 4EXPERIMENTALRandomized 7 drug/2 placebo by group

Interventions

NameTypeDescription
LutikizumabDRUGSubcutaneous injection
PlaceboDRUGSubcutaneous injection
RavagalimabDRUGSubcutaneous (SC) injection
RisankizumabDRUGSubcutaneous (SC) Injection
AdalimumabDRUGSC Injection
ABT-981BIOLOGICALABT-981 administered by subcutaneous injection
Placebo for ABT-981BIOLOGICALPlacebo for ABT-981 administered by subcutaneous injection
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites279

Inclusion Criteria: * Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant). * Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline * Hidradenitis suppurativa (HS) lesi...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBosnia and HerzegovinaBulgariaCanadaChileColombiaCroatiaCzechiaDenmarkFranceGermanyGreeceGuatemalaHungaryIrelandIsraelItalyJapanLithuaniaMexicoNetherlandsNew ZealandNorwayPolandPortugalPuerto RicoRomaniaSaudi ArabiaSerbiaSingaporeSlovakiaSloveniaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTaiwanTurkey (Türkiye)United KingdomEstoniaLatvia
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Recent Changes (Last 90 Days)

MEDIUMOct 8, 2026NCT06972446lastUpdatePostDate: changed
MEDIUMOct 8, 2026NCT06972446lastUpdatePostDate: changed
MEDIUMSep 22, 2026NCT06972446lastUpdatePostDate: changed
MEDIUMSep 22, 2026NCT06972446lastUpdatePostDate: changed
LOWSep 2, 2026NCT06468228lastUpdatePostDate: changed
LOWSep 2, 2026NCT06468228lastUpdatePostDate: changed
LOWSep 2, 2026NCT06468228lastUpdatePostDate: changed
LOWAug 21, 2026NCT06468228lastUpdatePostDate: changed
LOWAug 21, 2026NCT06468228lastUpdatePostDate: changed
LOWAug 14, 2026NCT06718101lastUpdatePostDate: changed
LOWAug 14, 2026NCT06468228lastUpdatePostDate: changed
LOWAug 14, 2026NCT06718101lastUpdatePostDate: changed
LOWAug 14, 2026NCT06468228lastUpdatePostDate: changed
MEDIUMAug 4, 2026NCT06718101lastUpdatePostDate: changed
MEDIUMAug 4, 2026NCT06718101lastUpdatePostDate: changed
MEDIUMAug 3, 2026NCT06718101lastUpdatePostDate: changed
MEDIUMAug 3, 2026NCT06718101lastUpdatePostDate: changed

Frequently asked questions about ABT-981

What is ABT-981 used for?

ABT-981 is an investigational monoclonal antibody being studied for osteoarthritis, including erosive hand osteoarthritis and knee osteoarthritis. It was developed to treat the signs and symptoms of these musculoskeletal conditions. It has not been approved for any indication and remains in clinical development.

What does ABT-981 target?

ABT-981 targets interleukin-1 alpha and interleukin-1 beta, two forms of the IL-1 cytokine. It is an interleukin antagonist monoclonal antibody designed to bind and neutralize both IL-1α and IL-1β, which are mediators of inflammation and cartilage degradation in osteoarthritis.

Who makes ABT-981?

ABT-981 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the clinical trials evaluating the drug in osteoarthritis, including studies in erosive hand osteoarthritis and knee osteoarthritis.

What phase is ABT-981 in?

ABT-981 is in Phase 2 clinical development. It has completed a Phase 2a trial in erosive hand osteoarthritis and a Phase 2 trial in knee osteoarthritis, along with an earlier Phase 1 pharmacokinetics study. It is investigational and has not been approved by the FDA.

What clinical trials is ABT-981 in?

ABT-981 has been evaluated in three completed trials: NCT02384538, a Phase 2a study in erosive hand osteoarthritis with 132 patients; NCT02087904, a Phase 2 study in knee osteoarthritis with 350 patients; and NCT01668511, a Phase 1 pharmacokinetics study in knee osteoarthritis with 36 patients.

Is ABT-981 FDA approved?

No, ABT-981 is not FDA approved. It is an investigational monoclonal antibody that has completed Phase 2 clinical trials in erosive hand osteoarthritis and knee osteoarthritis. Further clinical development would be required before any potential regulatory approval.