RecruitingPhase 1

A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis

Italy42 participantsStarted 2026-03-04

Plain-language summary

The aim of this study is to evaluate the safety of F8IL10 when administered by intra-articular injection and to determine the maximum tolerated dose (MTD) in order to establish the recommended dose (RD) in patients with Reumatoid Arthritis.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients aged ≥18 and ≤80 years.
. Diagnosis of RA according to ACR/EULAR classification criteria (2010) with a disease duration exceeding 6 months.
. Presence of arthritis flare(s) suitable for IA injection in a knee, ankle, shoulder, wrist or elbow, despite treatment with stable doses (for at least 3 months) of DMARDs (conventional, biologic, and targeted synthetic) background therapy.
. No or stable regimens of NSAIDs and/or oral corticosteroid (≤ 10 mg/day; prednisone equivalent) for a period ≥2 weeks prior to screening.
. All acute toxic effects of any prior therapy must have resolved or returned to classification "mild" (grade 1) according to CTCAE v.5.0.
. Sufficient hematologic, liver and renal function defined as follows:
. Documented negative TB test (e.g. Quantiferon or equivalent).
. Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no ongoing infection are eligible.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

DLT

Timeframe: From Day 1 to Day 28 of the treatment

MAD, MTD and RD

Timeframe: From Day 1 to Day 28 of the treatment

AEs, SAEs and DILI

Timeframe: Through study completation (up to 37 weeks)

Incidence of injection site reactions

Timeframe: Through study completation (up to 37 weeks)

Standard laboratory parameters

Timeframe: Through study completion (up to 37 weeks)

Trial details

NCT IDNCT07245992

SponsorPhilogen S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09-30

Contact for this trial

Louis Plüss

+41 43 544 88 04 louis.pluss@philogen.com

View on ClinicalTrials.gov More Rheumatoid Arthritis (RA) trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients aged ≥18 and ≤80 years.
. Diagnosis of RA according to ACR/EULAR classification criteria (2010) with a disease duration exceeding 6 months.
. Presence of arthritis flare(s) suitable for IA injection in a knee, ankle, shoulder, wrist or elbow, despite treatment with stable doses (for at least 3 months) of DMARDs (conventional, biologic, and targeted synthetic) background therapy.
. No or stable regimens of NSAIDs and/or oral corticosteroid (≤ 10 mg/day; prednisone equivalent) for a period ≥2 weeks prior to screening.
. All acute toxic effects of any prior therapy must have resolved or returned to classification "mild" (grade 1) according to CTCAE v.5.0.
. Sufficient hematologic, liver and renal function defined as follows:
. Documented negative TB test (e.g. Quantiferon or equivalent).
. Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no ongoing infection are eligible.

Exclusion criteria

What they're measuring

DLT

Timeframe: From Day 1 to Day 28 of the treatment

MAD, MTD and RD

Timeframe: From Day 1 to Day 28 of the treatment

AEs, SAEs and DILI

Timeframe: Through study completation (up to 37 weeks)

Incidence of injection site reactions

Timeframe: Through study completation (up to 37 weeks)

Standard laboratory parameters

Timeframe: Through study completion (up to 37 weeks)