Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis

NCT ID
NCT07869134
Registry status
Not yet recruiting
Study type
Interventional
Phase
Phase 2
Sponsor
Forward Therapeutics
Conditions
Psoriatic Arthritis (PsA)

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Official title: A Proof-of-Concept Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Two Dose Levels of FT2109 in Biologic Naïve and Biologic Experienced Participants With Active Psoriatic Arthritis (PsA)

Enrollment: 210 participants (Estimated).

What is being studied

  • Drug: FT2109 Dosing Regimen 1
  • Drug: FT2109 Dosing Regimen 2
  • Drug: Matching Placebo

Who may be eligible

Ages
18 Years to 75 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Age 18-75 years * Body mass index (BMI) within the range 18 to 40 kg/m2 * Diagnosed with PsA for ≥6 months, and meeting Classification Criteria for Psoriatic Arthritis (CASPAR) at screening * Have active PsA: ≥3 tender joints and ≥3 swollen joints at screening and baseline and having hsCRP \>0.3 mg/dL (3 mg/L) * Having active plaque psoriasis (≥1 lesion ≥2cm) or nail psoriasis at screening * Biologic disease modifying anti-rheumatic drug (bDMARD) or targeted synthetic DMARD (tsDMARD) experienced participants can have received (a) up to one bDMARD (excluding TNF and IL-17 targeting therapies), and (b) up to one tsDMARD (excluding JAK targeting therapies) * bDMARD or tsDMARD naïve participants must have failed (a) at least one but no more than two csDMARDs AND/OR (b) Apremilast Exclusion Criteria: * Presence of other inflammatory or autoimmune conditions, including but not limited to rheumatoid arthritis, primary ankylosing spondylitis or non-radiographic axial spondyloarthritis without psoriasis, systemic lupus erythematosus, drug-induced dermatosis, inflammatory bowel disease, or Lyme disease * Current non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis) * Use of \>10mg/day prednisone equivalent or change in oral glucocorticoid dosage within 4 weeks prior to Baseline * Received targeted intra-articular, trigger point, tender point, intra-bursa, or intra-tendon sheath surgical or pharmacological treatment within 8 weeks of the Screening Visit * Undergone surgical treatment for PsA including synovectomy and arthroplasty in more than 3 joints and/or within the last 12 weeks prior to the Screening Visit.

Study locations

No study locations are listed in the registry data.

Study details

Start date
December 1, 2026
Primary completion date
October 1, 2027
Completion date
November 1, 2027
First posted
October 9, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07869134
Registry last updated
October 9, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07869134 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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