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NCT06865105 · ClinicalTrials.gov registry record · Phase 2
Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis
A Phase 2 study of Psoriatic Arthritis, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT06865105: Recruiting Phase 2 study of Psoriatic Arthritis, sponsored by AbbVie.
NCT06865105 is a Phase 2 study of Psoriatic Arthritis that is actively recruiting participants, run by AbbVie. The registered enrollment target is 120 participants, below the 850-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06865105, a Phase 2 study of Psoriatic Arthritis, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study 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. 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Lutikizumab
- DRUG Risankizumab
Study Locations (20)
Florida
- Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085 - Avon Park
- Clinical Research Of West Florida - Phase I Unit /ID# 273198 - Clearwater
- HMD Research LLC /ID# 273086 - Orlando
- West Broward Rheumatology Associates /ID# 272892 - Tamarac
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199 - Tampa
Texas
- Tekton Research - West Gate /ID# 272765 - Austin
- Accurate Clinical Research - Houston /ID# 272754 - Houston
- Tekton Research, LLC /ID# 272901 - San Antonio
- Dynamed Clinical Research - Tomball /ID# 272760 - Tomball
Illinois
- Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879 - Skokie
- Willow Rheumatology and Wellness, PLLC /ID# 277354 - Willowbrook
California
- Newport Huntington Medical Group /ID# 272764 - Huntington Beach
Maryland
- Klein And Associates /ID# 272829 - Hagerstown
Ohio
- Paramount Medical Research and Consulting /ID# 272757 - Middleburg Heights
Pennsylvania
- Altoona Center For Clinical Research /ID# 272593 - Duncansville
Tennessee
- Private Practice - Dr. Ramesh C. Gupta I /ID# 272897 - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-04-11 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
What NCT06865105 shows while recruiting
NCT06865105 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 850-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Psoriatic Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Lutikizumab is the first listed.
NCT06865105 names 20 study sites across 12 states, led by Florida, Texas, Illinois.
Frequently Asked Questions
What is clinical trial NCT06865105 about?
NCT06865105 is a clinical study titled "Study of Targeted Therapies for the Treatment of Adult Participants 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 th...
What is the current status of trial NCT06865105?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-04-11. Estimated completion is 2028-01.
What conditions does trial NCT06865105 study?
This clinical trial studies the following conditions: Psoriatic Arthritis.
What interventions are being tested in trial NCT06865105?
The interventions under investigation include: Lutikizumab (DRUG), Risankizumab (DRUG).
Who is sponsoring clinical trial NCT06865105?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06865105 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06865105's enrollment target sits among peer trials
120 35th of 48 higher than 14 of 48 other Psoriatic Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriatic Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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