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Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis

ConditionPsoriatic Arthritis (PsA)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorForward Therapeutics

About this trial

This study will investigate if the study medicine FT2109 can treat symptoms of active Psoriatic Arthritis (PsA). This study assesses the safety and efficacy of FT2109 in adult participants with active PsA who may or may not have been treated previously with advanced therapy and who may be on stable background therapy.

In this study, researchers will look at different doses of FT2109 compared to placebo (a treatment with no active study drug in it). Researchers will try to learn if at least one of the study doses of FT2109 works better than placebo to treat PsA symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • FT2109 Dosing Regimen 1

    Drug

    Administered daily for 12 weeks

  • FT2109 Dosing Regimen 2

    Drug

    Administered daily for 12 weeks

  • Matching Placebo

    Drug

    Administered daily for 12 weeks

Treatment groups

210 Participants
are divided into 3 treatment groups
Group A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants who achieved an American College of Rheumatology (ACR) 20 response at Week 12

The ACR20 response is defined as the proportion of participants with at least a 20% improvement in tender joint count (TJC) out of 68 joints, a 20% improvement in swollen joint count (SJC) out of 66 joints, and a 20% improvement in three of the following five criteria: participant pain, participant global assessment of disease, physician global assessment of disease, physical functioning assessment (HAQ-DI), and high-sensitivity C-reactive protein (hsCRP).

Time frame
Week 12

Secondary outcomes

1

Incidence of TEAEs, SAEs, and clinically significant laboratory findings, vital signs, and 12-lead ECGs

Treatment-Emergent Adverse Events (TEAEs) are defined as adverse events (AEs) that occurred or worsened after the first dose of trial intervention. A Serious Adverse Event (SAE) is defined as an AE that results in death, is life-threatening, requires or prolongs a hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Time frame
Baseline to Week 16
2

Proportion of participants with ACR20 response at Weeks 2, 4, and 8

Time frame
Baseline to Weeks 2, 4, and 8
3

Proportion of participants with ACR50 and ACR70 response at Weeks 2, 4, 8, and 12

ACR50 and ACR70 use the same criteria as ACR20 with improvement levels defined as 50% and 70%, respectively, versus 20% for ACR20.

Time frame
Baseline to Weeks 2, 4, 8, and 12
4

Proportion of participants with MDA and VLDA at Weeks 2, 4, 8, and 12

Minimal Disease Activity (MDA) meets ≥5 of 7 and Very Low Disease Activity (VLDA) meets 7 of 7 of the following criteria: TJC ≤1; SJC ≤1; tender entheseal points ≤1; participant global visual analog scale (VAS) ≤20 mm; participant pain VAS ≤15 mm; HAQ ≤0.5; and Psoriasis Area and Severity Index (PASI) ≤1 or body surface area (BSA) involvement ≤3%.

Time frame
Baseline to Weeks 2, 4, 8, and 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Forward Therapeutics

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: