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Lutikizumab

Phase 3

Hidradenitis Suppurativa | Monoclonal antibody | Dermatology |AbbVie Inc.|Last Updated: Jul 16, 2026

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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment1,670
FDA Designations
No designations recorded
Clinical trial landscape

Lutikizumab · 7 trials · 5 indications

Phase 3 1Phase 2 6
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.

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.
Sub-Study 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.
Interventions
NameTypeDescription
LutikizumabDRUGSubcutaneous injection
PlaceboDRUGSubcutaneous injection
RavagalimabDRUGSubcutaneous (SC) injection
RisankizumabDRUGSubcutaneous (SC) Injection
AdalimumabDRUGSC 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...

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Recent Changes (Last 90 Days)
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