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Psoriatic ArthritisPhase 2NCT06865105

Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis

A Phase 2 study testing Lutikizumab and Risankizumab in people with Psoriatic Arthritis, run by AbbVie at 37 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Lutikizumab and Risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
37 sitesin 6 countries
Study dates
11 Apr 2025to Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant is willing and able to comply with procedures required in the Master Protocol and substudies.
  • Participant has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening Visit.
  • Participant has active disease defined as greater than or equal to 3 tender joints (based on 68 joint count) and greater than or equal to 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline.
  • Participant has active plaque PsO and/or a documented history of plaque PsO.
  • Participant must demonstrate intolerance or inadequate response to 1 to 2 targeted therapies (biologic or targeted synthetic disease-modifying antirheumatic drugs) approved for the treatment of PsA

Who cannot join

  • Participants who have had major surgery performed within 12 weeks prior to randomization or plan to have a major surgery during conduct of the study (e.g., aneurysm removal, stomach ligation).
  • Participants with the following chronic or active infections: Are infected with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB)
  • Active skin disease other than psoriasis (PsO) which could interfere with the assessment of PsO.
  • History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).

Trial locations and contacts

37 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

37 sites in 6 countries

United States16 sites, 15 recruiting

  • Tekton Research - West Gate /ID# 272765

    Austin, Texas, 78745

    Recruiting

  • Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085

    Avon Park, Florida, 33825

    Site Coordinator, 863-314-8555

    Recruiting

  • Clinical Research Of West Florida - Phase I Unit /ID# 273198

    Clearwater, Florida, 33765

    Recruiting

  • Altoona Center For Clinical Research /ID# 272593

    Duncansville, Pennsylvania, 16635

    Site Coordinator, 814-296-6108

    Recruiting

  • Klein And Associates /ID# 272829

    Hagerstown, Maryland, 21740

    Completed

  • Accurate Clinical Research - Houston /ID# 272754

    Houston, Texas, 77089-6142

    Site Coordinator, 281-481-8557

    Recruiting

  • Newport Huntington Medical Group /ID# 272764

    Huntington Beach, California, 92648-5994

    Site Coordinator, 714-923-7112

    Recruiting

  • Private Practice - Dr. Ramesh C. Gupta I /ID# 272897

    Memphis, Tennessee, 38119

    Recruiting

  • Paramount Medical Research and Consulting /ID# 272757

    Middleburg Heights, Ohio, 44130

    Recruiting

  • HMD Research LLC /ID# 273086

    Orlando, Florida, 32819

    Recruiting

  • Tekton Research, LLC /ID# 272901

    San Antonio, Texas, 78251

    Recruiting

  • Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879

    Skokie, Illinois, 60076

    Site Coordinator, 847-599-2492

    Recruiting

  • West Broward Rheumatology Associates /ID# 272892

    Tamarac, Florida, 33321

    Recruiting

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199

    Tampa, Florida, 33606

    Site Coordinator, (813) 870-1292

    Recruiting

  • Dynamed Clinical Research - Tomball /ID# 272760

    Tomball, Texas, 77375

    Recruiting

  • Willow Rheumatology and Wellness, PLLC /ID# 277354

    Willowbrook, Illinois, 60527

    Recruiting

Other trials in United States

France5 sites, 5 recruiting

  • CHU Bordeaux - Hopital Pellegrin /ID# 273390

    Bordeaux, New Aquitaine, 33076

    Recruiting

  • Infirmerie Protestante De Lyon /ID# 273731

    Caluire-et-Cuire, Auvergne-Rhône-Alpes, 69300

    Recruiting

  • Centre Hospitalier Régional Universitaire De Tours - Hôpital Trousseau /ID# 272762

    Chambray-lès-Tours, Indre-et-Loire, 37170

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771

    Nice, Alpes-Maritimes, 06001

    Recruiting

  • Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 272877

    Orléans, 45067

    Recruiting

Other trials in France

Hungary5 sites, 5 recruiting

  • Semmelweis Egyetem Reumatológiai és Immunológiai Klinika /ID# 273195

    Budapest, 1023

    Recruiting

  • Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857

    Budapest, 1027

    Recruiting

  • Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572

    Miskolc, Borsod-Abauj Zemplen county, 3529

    Recruiting

  • Complex Rendelo Med Zrt. /ID# 272570

    Székesfehérvár, Fejér, 8000

    Recruiting

  • Vital-Medicina Kft. /ID# 272855

    Veszprém, Fejér, 8200

    Recruiting

Other trials in Hungary

Poland5 sites, 5 recruiting

  • Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304

    Bialystok, Podlaskie Voivodeship, 15-351

    Recruiting

  • Mics Centrum Medyczne Bydgoszcz /ID# 273297

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-068

    Recruiting

  • Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306

    Elblag, Warmian-Masurian Voivodeship, 82-300

    Recruiting

  • MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305

    Pruszków, Masovian Voivodeship, 05-800

    Recruiting

  • Centrum Medyczne Reuma Park /ID# 273301

    Warsaw, Masovian Voivodeship, 02-665

    Recruiting

Other trials in Poland

Czechia4 sites, 4 recruiting

  • Revmatologie /ID# 272367

    Brno, Brno-mesto, 638 00

    Recruiting

  • L.K.N. Arthrocentrum /ID# 272366

    Hlučín, Moravian-Silesian Region, 748 01

    Recruiting

  • Medical Plus s.r.o. /ID# 272363

    Uherské Hradiště, 686 01

    Recruiting

  • PV Medical Services s.r.o. /ID# 272368

    Zlín, 760 01

    Recruiting

Other trials in Czechia

Canada2 sites, 2 recruiting

  • Dr. Latha Naik Medical Professional Corporation /ID# 272803

    Saskatoon, Saskatchewan, S7H 0P4

    Recruiting

  • Centre de Recherche Musculo-Squelettique /ID# 274397

    Trois-Rivières, Quebec, G9A 3X2

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.

The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being tested
Lutikizumab, Risankizumab
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LutikizumabDrug

    Subcutaneous (SC) Injection

  • RisankizumabDrug

    Subcutaneous (SC) Injection

Study groups in NCT06865105
Study groupRoleWhat they receive
Sub-Study 1: Risankizumab MonotherapyExperimentalParticipants will receive Risankizumab
Receives: Drug: Risankizumab
Sub-Study 1: Lutikizumab MonotherapyExperimentalParticipants will initially receive Lutikizumab Dose A followed by Lutikizumab Dose B every other week.
Receives: Drug: Lutikizumab
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.
Receives: Drug: Lutikizumab; Drug: Risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response

    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).

    Measured: At Week 16

  2. Number of Participants With Adverse Events (AEs)

    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.

    Measured: Up to Week 52

Secondary outcomes (4)

  1. Percentage of Participants Achieving Minimal Disease Activity (MDA) Response

    A participant was classified as achieving MDA if 5 of the following 7 criteria were met:

    • Tender joint count (out of 68 joints) ≤ 1
    • Swollen joint count (out of 66 joints) ≤ 1
    • PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
    • Participant's assessment of pain ≤ 1.5 (NRS from 0 to 10)
    • Participant's Global Assessment of disease activity ≤ 2 (NRS from 0 to 10)
    • HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
    • Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, with an overall score range from 0 to 6)

    Measured: At Week 16

  2. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

    1. ≥ 20% improvement in 68-tender joint count;
    2. ≥ 20% improvement in 66-swollen joint count; and
    3. ≥ 20% 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).

    Measured: At Week 16

  3. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:

    1. ≥ 70% improvement in 68-tender joint count;
    2. ≥ 70% improvement in 66-swollen joint count; and
    3. ≥ 70% 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).

    Measured: At Week 16

  4. Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Response (in the subset of participants with a PsO BSA ≥ 3% at Baseline)

    PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).

    The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from Baseline in PASI score, and was assessed in participants with Baseline psoriasis BSA involvement ≥ 3%.

    Measured: At Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2025
  2. Study start11 Apr 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06865105
Sponsor's protocol ID
M25-191
Status last verified
Dec 2025
First submitted
4 Mar 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutikizumab and Risankizumab in people with Psoriatic Arthritis, run by AbbVie at 37 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, France, Hungary, Poland, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response (time frame: At Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06865105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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