Rheumatoid ArthritisPhase 1NCT02076659
Combination Therapy of F8IL10 and Methotrexate in Rheumatoid Arthritis Patients
A Phase 1 study testing F8IL10 and Methotrexate in people with Rheumatoid Arthritis, run by Philogen S.p.A. at 5 sites in Italy.
Trial summary
Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- F8IL10 and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesItaly
- Study dates
- Sep 2011to 13 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients aged ≥ 18 and < 75 years.
- Diagnosis of RA according to ACR criteria (1987) with a disease duration exceeding 12 months.
- Active RA (DAS28 ≥ 3.2) for ≥ 4 months at time of signing informed consent.
- Receiving treatment on an outpatient basis.
- MTX at 10-15 mg/w for a period ≥ 8 weeks prior to treatment.
- Inadequate clinical response to at least one anti-TNF therapy applied for at least 4 months.
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- If patients are receiving an oral corticosteroid, the dose must have been stable for at least 25 out of 28 days prior to study treatment and the dose must be less than 10 mg/day (prednisolone equivalent).
- All acute toxic effects of any prior therapy must have returned to classification "mild" according to RCTC V.2.0 [1] .
- Sufficient hematologic, liver and renal function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin (Hb) ≥ 9.5 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 test for human immunodeficiency virus, HBV, and HCV. For 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.
- Male and female patients, who are potentially fertile, must agree to use adequate contraceptive methods at the beginning of the screening visit that must be continued until 3 months following the last treatment with study drug.
- Negative serum pregnancy test (for women of child-bearing potential only) at screening.
- Signed and dated Ethics Committee-approved Informed Consent Form indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- Presence of active infections (e.g. requiring antibiotic therapy) or other 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.
- Active or latent tuberculosis (TB).
- Chronic active hepatitis or active autoimmune diseases other than RA.
- History of currently active primary or secondary immounodeficiency.
- HIV Infection.
Show all 30Show fewer
- Acute or chronic-active infection with HBV or HCV, as assessed by serology or HBV DNA.
- Evidence of active malignant disease at screening or advanced malignancies diagnosed within the previous 5 years.
- Any previous treatment with alkylating agents, such as cyclophosphamide or chlorambucil or with total lymphoid irradiation.
- 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.
- Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
- Irreversible cardiac arrhythmias requiring permanent medication.
- Clinically significant (to clinical investigator's discretion) abnormalities in baseline MUGA, ECHO or ECG analyses.
- Uncontrolled hypertension.
- Ischemic peripheral vascular disease (Grade IIb-IV).
- Severe diabetic retinopathy.
- Major trauma including surgery within 4 weeks of administration of study treatment.
- Known history of allergy or other intolerance to IL10, MTX, folic acid or other drugs based on human proteins/peptides/antibodies.
- In vivo exposure to monoclonal antibodies for biological therapy (e.g., adalimumab,infliximab golimumab, tocilizumab, certolizumab pegol) less than 8 weeks prior to administration of study medication.
- Treatment with rituximab less than 4 months prior to administration of study medication.
- Treatment with fusion proteins (e.g. abatacept, etanercept) less than 4 weeks prior to administration of study medication.
- Treatment with any investigational agent within the 6 weeks before study treatment.
- Immunization with a live/attenuated vaccine within 4 weeks prior to baseline.
- Growth factors or immunomodulatory agents, including anakinra, within 7 days of the administration of study treatment.
- Neuropathy > Grade 1 or Neuropathies or other painful conditions (not RA-related) that might interfere with pain evaluation.
- Patients required to be treated with corticosteroids at a dose > 10 mg/day or with immunosuppressant drugs other than MTX on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion.
- History of alcohol, drug or chemical substance abuse within the 6 months prior to screening.
- Body weight of >100 kg.
- Any condition that in the opinion of the investigator could hamper compliance with the study protocol.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Policlinico San Matteo, Pavia
Pavia
Pisa University Hospital
Pisa
Azienda Ospedaliera San Camillo-Forlanini Roma
Roma
Policlinico A. Gemelli, Università Cattolica del Sacro Cuore
Roma
Siena University Hospital
Siena
About this study
Official title: A Dose-finding, Pharmacokinetic Phase I Study of the Human Monoclonal Antibody-cytokine Fusion Protein F8IL10 (Dekavil) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.
Read the detailed description
The study is designed to explore whether F8IL10 can be safely administered in combination with standard-dose of MTX in patients with active rheumatoid arthritis and to determine the recommended dose of F8IL10 when combined with MTX.
As soon as the MTD/RD is determined, an additional 12 patients will be randomized (6+6) between F8IL10 (RD) and placebo to further investigate the safety and pharmacacodynamics profile of the study treatment.
Methotrexate (MTX) will be administered as concomitant medication in the dose escalation as well as in the randomized part of the study.
- Conditions
- Rheumatoid Arthritis
- Being tested
- F8IL10, Methotrexate
- Keywords
- F8, IL10, Interleukin, monoclonal, antibody, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F8IL10Drug
Weekly administration of F8IL10 (from 6 to 600 μg/kg), starting from 6 μg/kg cohort 1. The cohort 10 represents the last dose-level of the study.
F8IL10 will be administered as subcutaneous (s.c.) injections. Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent.
MethotrexateDrug
Methotrexate will be administered at a fixed dose of 10-15 mg on Day 1, orally (p.o.), subcutaneously (s.c.) or intramuscularly (i.m.).
Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| F8IL10 + MTX | Experimental | Ten cohorts of 3-6 RA patients will be treated at increasing doses per cohort of F8IL10 plus fixed doses of MTX and folic acid.
An additional 12 patients will be randomized (6+6) in a double blind, placebo controlled cohort with F8IL10 given at RD and placebo. In both arms, MTX will be administered as concomitant medication.
In all coohorts a stable dose of folic acid (5 mg) will be administered on Day 2. Receives: Drug: F8IL10; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage
To establish the MTD and the RD of F8IL10 when administered in combination with methotrexate
Measured: Up to day 28
Secondary outcomes (16)
Maximum drug concentration [Cmax]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Time to reach maximum drug concentration [Tmax]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Terminal half-life [t1/2]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Area under the drug concentration-time curve [AUC(0 - t last)]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Area under the drug concentration-time curve, extrapolated to infinity [AUC]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Accumulation ratio for AUC [R AUC]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Accumulation ratio for Cmax [Rmax]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Accumulation ratio for Cmin [R min]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Total clearance following the dose administered [CL]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Volume of distribution at steady state [Vss]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Mean residence time [MRT]
Pharmacokinetics assessment of F8IL10 through blood sampling
Measured: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Human anti-fusion protein antibodies (HAFA) levels
Investigate the potential induction of human anti-fusion protein antibodies (HAFA) through standard laboratory analysis.
Measured: 1) at day 1 of week 1; 2) at day 1 of week 4; 3) from week 5 up to week 9 (EoT visit)
Response rate according to EULAR criteria (Good, Moderate and Non-responders) based on DAS28 score
To explore the antiarthritic activity of the study medication in patients with active rheumatoid arthritis.
Measured: 1) from day -14 up to day 0 (screening); 2) at day 1 of week 5; 3) at day 1 of week 9; 4) from week 9-13 up to week 57-61, every 4 weeks (safety/efficacy follow-up)
ACR 20, ACR 50, ACR 70 response rate
To explore the antiarthritic activity of the study medication in patients with active rheumatoid arthritis.
Measured: 1) from day -14 up to day 0 (screening); 2) at day 1 of week 5; 3) at day 1 of week 9; 4) from week 9-13 up to week 57-61, every 4 weeks (safety/efficacy follow-up)
Change from baseline in DAS28
To explore the antiarthritic activity of the study medication in patients with active rheumatoid arthritis.
Measured: 1) from day -14 up to day 0 (screening); 2) at day 1 of week 5; 3) at day 1 of week 9; 4) from week 9-13 up to week 57-61, every 4 weeks (safety/efficacy follow-up)
Relative change over time of blood biomarkers
Measured: From day -14 up to day 0 (screening); at day 1 of week 1; at day 1 of week 5 /week 9 (EoT); from week 7 up to week 11 (safety follow-up); from week 11 up to week 15 (efficacy follow-up); from week 11-15 up to week 57-61, every 4 weeks (total follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startSep 2011
- Primary completionApr 2017
- Study completion13 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Philogen S.p.A.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philogen S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mauro Galeazzi, Prof, Principal investigator, Siena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076659
- Sponsor's protocol ID
- PH-F8IL10-02/08
- Other IDs
- 2008-008729-31, 2008
- Status last verified
- May 2018
- First submitted
- 24 Feb 2014
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-finding, Pharmacokinetic Phase I Study of the Human Monoclonal Antibody-cytokine Fusion Protein F8IL10 (Dekavil) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02076659
- Acronym / sponsor ID
- PH-F8IL10-02/08
- Conditions
- Rheumatoid Arthritis
- Keywords
- F8, IL10, Interleukin, monoclonal, antibody, Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Philogen S.p.A.Industry (pharma, biotech, devices)
- Study start
- Sep 2011 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I, multicenter, open-label, dose escalation study to test the efficacy and safety of F8IL10 and methotrexate when given as a combination in rheumatoid arthritis patients.
Detailed description
The study is designed to explore whether F8IL10 can be safely administered in combination with standard-dose of MTX in patients with active rheumatoid arthritis and to determine the recommended dose of F8IL10 when combined with MTX.
As soon as the MTD/RD is determined, an additional 12 patients will be randomized (6+6) between F8IL10 (RD) and placebo to further investigate the safety and pharmacacodynamics profile of the study treatment.
Methotrexate (MTX) will be administered as concomitant medication in the dose escalation as well as in the randomized part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F8IL10 + MTX | Experimental | Drug: F8IL10, Drug: MethotrexateTen cohorts of 3-6 RA patients will be treated at increasing doses per cohort of F8IL10 plus fixed doses of MTX and folic acid. An additional 12 patients will be randomized (6+6) in a double blind, placebo controlled cohort with F8IL10 given at RD and placebo. In both arms, MTX will be administered as concomitant medication. In all coohorts a stable dose of folic acid (5 mg) will be administered on Day 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients aged ≥ 18 and < 75 years.
- Diagnosis of RA according to ACR criteria (1987) with a disease duration exceeding 12 months.
- Active RA (DAS28 ≥ 3.2) for ≥ 4 months at time of signing informed consent.
- Receiving treatment on an outpatient basis.
- MTX at 10-15 mg/w for a period ≥ 8 weeks prior to treatment.
Key exclusion criteria (30 listed)
- Presence of active infections (e.g. requiring antibiotic therapy) or other 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.
- Active or latent tuberculosis (TB).
- Chronic active hepatitis or active autoimmune diseases other than RA.
- History of currently active primary or secondary immounodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F8IL10Weekly administration of F8IL10 (from 6 to 600 μg/kg), starting from 6 μg/kg cohort 1. The cohort 10 represents the last dose-level of the study. F8IL10 will be administered as subcutaneous (s.c.) injections. Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent. | Drug | F8IL10 + MTX |
| MethotrexateMethotrexate will be administered at a fixed dose of 10-15 mg on Day 1, orally (p.o.), subcutaneously (s.c.) or intramuscularly (i.m.). Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent. | Drug | F8IL10 + MTX |
Primary outcome
Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage
Time frame: Up to day 28
To establish the MTD and the RD of F8IL10 when administered in combination with methotrexate
16 secondary outcomes
Maximum drug concentration [Cmax]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Time to reach maximum drug concentration [Tmax]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Terminal half-life [t1/2]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Area under the drug concentration-time curve [AUC(0 - t last)]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Area under the drug concentration-time curve, extrapolated to infinity [AUC]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Accumulation ratio for AUC [R AUC]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Accumulation ratio for Cmax [Rmax]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Accumulation ratio for Cmin [R min]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Total clearance following the dose administered [CL]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Volume of distribution at steady state [Vss]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Mean residence time [MRT]
Time frame: At day 1, 4, 5, 6 of week 1; at day 1, 2, 3, 4, 5, 6 of week 4
Human anti-fusion protein antibodies (HAFA) levels
Time frame: 1) at day 1 of week 1; 2) at day 1 of week 4; 3) from week 5 up to week 9 (EoT visit)
Response rate according to EULAR criteria (Good, Moderate and Non-responders) based on DAS28 score
Time frame: 1) from day -14 up to day 0 (screening); 2) at day 1 of week 5; 3) at day 1 of week 9; 4) from week 9-13 up to week 57-61, every 4 weeks (safety/efficacy follow-up)
ACR 20, ACR 50, ACR 70 response rate
Time frame: 1) from day -14 up to day 0 (screening); 2) at day 1 of week 5; 3) at day 1 of week 9; 4) from week 9-13 up to week 57-61, every 4 weeks (safety/efficacy follow-up)
Change from baseline in DAS28
Time frame: 1) from day -14 up to day 0 (screening); 2) at day 1 of week 5; 3) at day 1 of week 9; 4) from week 9-13 up to week 57-61, every 4 weeks (safety/efficacy follow-up)
Relative change over time of blood biomarkers
Time frame: From day -14 up to day 0 (screening); at day 1 of week 1; at day 1 of week 5 /week 9 (EoT); from week 7 up to week 11 (safety follow-up); from week 11 up to week 15 (efficacy follow-up); from week 11-15 up to week 57-61, every 4 weeks (total follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Galeazzi, Prof principal investigator
Siena University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F8IL10 and Methotrexate in people with Rheumatoid Arthritis, run by Philogen S.p.A. at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events that are related to treatment and classified as DLTs for each administered dosage (time frame: Up to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.