Phase 2: testing Lutikizumab for 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.
Official registry: https://clinicaltrials.gov/study/NCT06865105 · AbbVie · enrollment listed as 300
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Lutikizumab, Risankizumab, or ABBV-701. The registry lists allocation as randomized. 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.
They plan to enroll about 300 people at 41 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis
Interventions: Lutikizumab, Risankizumab, ABBV-701, ABBV-547
Primary outcome (registry wording): Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Participant is willing and able to comply with procedures required in the Master Protocol and relevant, actively enrolling 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 Visit
- Participant has active plaque PsO, with at least one psoriatic plaque of \>= 2 cm diameter or nail changes consistent with PsO at Screening Visit
- 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 the registry excludes
- 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 active, chronic, or recurring 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
Public study contact (from the registry)
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
41 listed- Newport Huntington Medical Group /ID# 272764 — Huntington Beach, California (recruiting)
- Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085 — Avon Park, Florida (recruiting)
- Clinical Research Of West Florida - Phase I Unit /ID# 273198 — Clearwater, Florida (recruiting)
- HMD Research LLC /ID# 273086 — Orlando, Florida (recruiting)
- West Broward Rheumatology Associates /ID# 272892 — Tamarac, Florida (recruiting)
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199 — Tampa, Florida (recruiting)
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 275469 — Chicago, Illinois (recruiting)
- Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879 — Skokie, Illinois (completed)
- Willow Rheumatology and Wellness /ID# 277354 — Willowbrook, Illinois (recruiting)
- Klein & Associates /ID# 272829 — Cumberland, Maryland (completed)
- Dartmouth-Hitchcock Medical Center /ID# 272702 — Lebanon, New Hampshire (recruiting)
- Paramount Medical Research and Consulting /ID# 272757 — Middleburg Heights, Ohio (recruiting)
+ 22 sites outside the US on the same record
FAQ about this NCT record
Is NCT06865105 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06865105?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06865105?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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