A Study of F8IL10 Intra-articular Treatment in Rheumatoid Arthritis

NCT07245992 | Recruiting Phase 1

• 2 other identifiers: PH-F8IL10INTRA-03/242024-517896-19-00
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

• DLT

  Occurrence of dose limiting toxicity (DLT)

  From Day 1 to Day 28 of the treatment

• MAD, MTD and RD

  Definition of maximum administered dose (MAD), maximum tolerated dose (MTD) and recommended dose (RD)

  From Day 1 to Day 28 of the treatment

• AEs, SAEs and DILI

  Adverse events (AEs), serious adverse events (SAEs) and Drug-Induced Liver Injury (DILI), based on Common Terminology Criteria for Adverse Events v. 5.0 (CTCAE).

  Through study completation (up to 37 weeks)

• Incidence of injection site reactions

  Incidence of injection site reactions and general reactions associated with intraarticular administration

  Through study completation (up to 37 weeks)

• Standard laboratory parameters

  Standard laboratory (haematology, biochemistry, liver and urine analysis) parameters.

  Through study completion (up to 37 weeks)

Secondary Outcomes (6)

• CCI: Composite change index

  Every 4 weeks, up to week 37

• SF-36

  Every 4 weeks, up to week 37

• Joint inflammation

  Every 4 weeks, up to week 37

• SDAI

  Every 4 weeks, up to week 37

• Pharmacokinetic profile

  Every 2 weeks, up to week 7

Study Arms (1)

Treatment

EXPERIMENTAL

The study will take place in two stages: 1. In the dose escalation part, participants will be enrolled in cohorts and will be treated with different dose levels of F8IL10 in order to identify a RD. In each cohort, 1 to 6 patients will be treated until the MAD is reached. 2. Following successful identification of the RD, the study will proceed with a dose expansion part, during which 12 patients will be treated at RD (including those treated in the dose escalation part).

Drug: F8IL10

Interventions

F8IL10 DRUG

Intra-articular treatment

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L, platelets ≥100 x109/L, haemoglobin (Hb) ≥10.0 g/dL.
• Alkaline Phosphatase (AP), Alanine Aminotransferase (ALT) and or Aspartate Aminotransferase (AST) ≤3 x Upper Limit of Normal Range (ULN), and total bilirubin ≤2.0 mg/dl (34.2 μmol/L).
• Creatinine ≤1.5 ULN or 24 h creatinine clearance ≥50 mL/min.
• 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.
• Sexually active male or female patients of childbearing potential are eligible providing that:
• Women of childbearing potential (WOCBP) have a negative pregnancy test performed within 4 weeks prior to treatment start.
• WOCBP agree to use, from the screening to 6 months following the last study drug administration, effective method of birth control as applicable per local law that both results in a Pearl index \<1 and considered highly effective as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the "Clinical Trial Facilitation Group" (e.g. combined estrogen and progestogen containing hormonal contraception, progestogen-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, vasectomized partner, total sexual abstinence or bilateral tubal occlusion).
• Males agree to use two acceptable methods of contraception (e.g. condom with spermicidal gel) from the screening to 6 months following the last study drug administration. Females of childbearing potential that are partners of male study participants must observe the same birth control indications that apply to female participants.

You may not qualify if:

• Presence of additional RA flares or RA-related symptoms that, in the investigator's judgment, are likely to require local treatment during the study (defined as intra-articular or peri-articular injections/procedures intended to treat RA; e.g., joint, tendon-sheath, or bursal corticosteroid injections; hyaluronic acid; biologic/PRP injections; or radio synovectomy).\_
• Presence of active infections or another severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or would interfere with the study objectives or conduct.
• Pregnancy, lactation or unwillingness to use adequate contraceptive methods.
• Diagnosis of any other inflammatory arthritis or active autoimmune diseases other than RA.
• Any therapy for RA apart from the allowed background therapy (i.e., stable doses of DMARDs, corticosteroids, and/or NSAIDs) within 4 weeks prior to the first IMP dosing.
• Received intra-articular administration of corticosteroids/DMARDs within 4 weeks or 5 half-lives prior to the first IMP dosing, whichever is longer.
• History or currently active primary or secondary immunodeficiency.
• Concurrent malignancy or history of malignancy (except in situ melanoma and low-risk non melanoma skin cancer) from which the patient has been disease-free for less than 2 years.
• History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
• Treatment with warfarin or other coumarin derivatives.
• Clinically significant cardiac arrhythmias or requiring permanent medication.
• Abnormalities in baseline ECG analysis that are considered as clinically significant by the investigator; subjects with current or a history of QT/QTc prolongation.
• Uncontrolled hypertension, despite optimal treatment.
• Known arterial aneurism at high risk of rupture.
• Ischemic peripheral vascular disease (Grade IIb-IV according to Leriche Fontaine classification).

Sponsors & Collaborators

• Philogen S.p.A.: lead

Study Sites (2)

Arcispedale Santa Maria Nuova

Reggio Emilia, Reggio Emilia, 42123, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona c/o Policlinico GB Rossi (Borgo Roma), Dep. Reumatologia

Verona, VR, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Louis Plüss

CONTACT

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

Federica Bastioli, Pharmaceutical Chemist

CONTACT

regulatory@philogen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The dose escalation part of the study is designed with an accelerated phase, followed by a classical 3+3 dose escalation scheme. During the accelerated phase from 25 to 1000 μg F8IL10, cohorts contain one patient until the first instance of a treatment-related AE or DLT in the observation period from Day 1 - Day 28. With the occurrence of a treatment-related AE in the DLT observation period, two additional patients will be treated at the same dose level. If these two patients do not experience a treatment-related AE or a DLT, the accelerated phase of the study with initially one patient per dose level continues. With the second occurrence of a treatment-related AE (without DLT) within the observation period, the accelerated phase will be terminated, and the dose escalation part continues following the classical 3+3 design at the next higher dose level. With the first occurrence of a DLT in the DLT observation period, the dose escalation continues with the classical 3+3 design.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)