Psoriatic Arthritis (PsA)Phase 2NCT07869134
Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis
A Phase 2 study testing FT2109 Dosing Regimen 1 and FT2109 Dosing Regimen 2 in people with Psoriatic Arthritis (PsA), run by Forward Therapeutics.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriatic Arthritis (PsA)
- What is being tested?
- FT2109 Dosing Regimen 1 and FT2109 Dosing Regimen 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the detailed description
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).
- Conditions
- Psoriatic Arthritis (PsA)
- Being tested
- FT2109 Dosing Regimen 1, FT2109 Dosing Regimen 2, Matching Placebo
- Keywords
- FT2109, Psoriatic Arthritis (PsA), Joint Diseases, Skin Diseases, Spondylarthropathies, Plaque Psoriasis
- Medical subject headings
- Arthritis, Psoriatic, Joint Diseases, Skin Diseases, Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT2109 Dosing Regimen 1Drug
Administered daily for 12 weeks
FT2109 Dosing Regimen 2Drug
Administered daily for 12 weeks
Matching PlaceboDrug
Administered daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: FT2109 Dosing Regimen 1 |
| Arm 2 | Experimental | Not described Receives: Drug: FT2109 Dosing Regimen 2 |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 12
Secondary outcomes (7)
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.
Measured: Baseline to Week 16
Proportion of participants with ACR20 response at Weeks 2, 4, and 8
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline to Weeks 2, 4, 8, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic Arthritis (PsA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forward Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869134
- Sponsor's protocol ID
- FT2109-2201
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No