A Phase 2 interventional study of FT2109 Dosing Regimen 1 and FT2109 Dosing Regimen 2 in Psoriatic Arthritis (PsA), sponsored by Forward Therapeutics. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Forward Therapeutics · Phase 2, Interventional, and Treatment
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.
This study consists of a 4-week screening period, 12-week treatment period, and a 4-week follow up period. Participants will be randomized 1:1:1 to Dose Regimen 1, Dose Regimen 2, or Placebo (\~70 participants/arm).
594 studies on the registry are indexed under Arthritis, Psoriatic; 132 are open to participants now.
This study's planned enrollment of 210 is above the median of 138 across 329 interventional studies indexed under Arthritis, Psoriatic.
Browse Arthritis, Psoriatic studies →This is the only study on the registry with Forward Therapeutics as lead sponsor.
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Exclusion Criteria:
Drug: FT2109 Dosing Regimen 1
Drug: FT2109 Dosing Regimen 2
Drug: Matching Placebo
Administered daily for 12 weeks
Administered daily for 12 weeks
Administered daily for 12 weeks
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
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
Proportion of participants with ACR20 response at Weeks 2, 4, and 8
Time frame: Baseline to Weeks 2, 4, and 8
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
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
Change from baseline to Weeks 2, 4, 8, and 12 in DAPSA score
Disease Activity in Psoriatic Arthritis (DAPSA) is calculated based on TJC out of 68 joints, SJC out of 66 joints, hsCRP, participant's assessment of rheumatic disease activity, and participant's assessment of pain severity.
Time frame: Baseline to Weeks 2, 4, 8, and 12
Proportion of participants with DAPSA low disease activity (LDA) (≤14) and DAPSA remission (≤4) at Weeks 2, 4, 8, and 12
Time frame: Baseline to Weeks 2, 4, 8, and 12
Proportion of participants with PASI 75 and PASI 90 response at Weeks 2, 4, 8, and 12 in participants with baseline BSA involvement ≥3%
Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response are binary outcomes indicating ≥75% and ≥90% improvement, respectively, in PASI from baseline. For each of four body regions, the area of involvement is scored from 0 to 6 and multiplied by the sum of three severity scores (erythema, induration, and desquamation, each scored 0 to 4). Each region is then weighted by its proportion of total body surface area: head = 0.1, upper extremities = 0.2, trunk = 0.3, lower extremities = 0.4. The total PASI is the sum of all four weighted regional scores.
Time frame: Baseline to Weeks 2, 4, 8, and 12
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Oct 2027, 10 months later.
Of 33 phase 2 interventional studies under Arthritis, Psoriatic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 31. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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