Knee OsteoarthritisPhase 2ALBATROSS-3NCT02205814
Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee
A Phase 2 study testing Fasitibant- low dose, Fasitibant- intermediate dose and Fasitibant- high dose in people with Knee Osteoarthritis, run by Menarini Group at 25 sites in 4 countries.
Trial summary
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Fasitibant- low dose, Fasitibant- intermediate dose and Fasitibant- high dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 436 participants
- Where
- 25 sitesin 4 countries
- Study dates
- Apr 2014to Jan 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
Who cannot join
- History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
- Any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
- Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
- Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
- Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
- Evidence of clinically significant hepatic disease or of moderate or severe renal insufficiency
Show all 12Show fewer
- Current use of any medications that are substrate of CYP3A4 and/or moderate or strong CYP3A4 inhibitors
- Patients with any clinically relevant or unstable disease, or malignant neoplasms that, in the opinion of the Investigator, may pose the patient at risk, or confound the efficacy and safety results of the study
- Patients with any clinically relevant abnormal safety laboratory test results, and/or abnormalities in vital signs, and/or ECG parameters
- Pregnant and breastfeeding women
- Any sign of significant immunodeficiency, systemic infection, knee infection or knee bursitis
- Patients with bleeding diathesis or on therapy with anticoagulants
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States9 sites
Blair Orthopaedic Associates
Altoona, Pennsylvania, 16602
Tekton Research
Austin, Texas, 78745
Radiant Research
Columbus, Ohio, 43212
Columbus Clinical Research
Columbus, Ohio, 43213
Avail Clinical Research, LLC
DeLand, Florida, 32720
Physicians Research Options, LLC
Draper, Utah, 84020
Colorado Orthopaedic Consultants
Englewood, Colorado, 80110
Spokan Joint Replacement Center
Spokane, Washington, 99218
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
Italy7 sites
Azienda Ospedaliero-Universitaria S.Anna/ Unità Operativa Complessa e Sezione di Reumatologia/Dipartimento di Medicina Clinica e Sperimentale
Cona, 44124
Dipartimento di Medicina Interna - SOD di Reumatologia Azienda - Ospedaliero Universitaria Careggi
Florence, Tuscany, 50139
Ospedale Galateo U.O. di Reumatologia
Lecce, 73016
Ospedale Fornaroli/Unità Complessa di Reumatologia
Magenta, 20013
Ospedale Luigi Sacco, Azienda Ospedaliera, Polo Universitario/Unità Operativa Complessa di Reumatologia
Milan, 20157
Azienda Ospedaliera di Perugia/Policlinico di Monteluce/Unità Operativa diagnosi e cura delle malattie reumatiche
Perugia, 06122
Centro Ricerche Cliniche di Verona
Verona, 37134
Germany6 sites
Synexus Clinical Research GmbH, Research Centre Berlin
Berlin, 1262
Synexus Clinical Research GmbH, Research Centre Bochum
Bochum, 44787
Synexus Clinical Research GmbH, Research Centre Frankfurt
Frankfurt, 60596
Clinical Research Hamburg GmbH
Hamburg, 22143
Synexus Clinical Research GmbH, Research Centre Leipzig
Leipzig, 04103
AmBeNet GmbH
Leipzig, 04107
Czechia3 sites
Revmatologie s.r.o.
Brno, 638 00
Institute of Rheumatology, Charles University Faculty Hospital
Prague, 128 50
MEDICAL PLUS s.r.o
Uherské Hradiště, 686 01
About this study
Official title: A Double-blind, Randomised, Placebo-controlled, Four Parallel Arm, Dose-finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Intra-articular Injections of Fasitibant in Patients With Symptomatic Osteoarthritis of the Knee.
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic osteoarthritis (OA) of the knee.
Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a total of 4 treatment arms. Each arm includes a single intra-articular injection of one of three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation ratio will be 1:1:1:1.
Read more
The primary efficacy variable will be the change of the Western Ontario and McMaster Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and clinical laboratory tests; local tolerability at the injection site will also be assessed. In addition, the population pharmacokinetics and the exposure-response relationship will be evaluated.
The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7 planned visits at site, including screening, randomisation, 4 follow-up visits and the End of study visit.
- Conditions
- Knee Osteoarthritis
- Being tested
- Fasitibant- low dose, Fasitibant- intermediate dose, Fasitibant- high dose, Placebo comparator
- Keywords
- Osteoarthritis, Knee, Arthritis, WOMAC, Injections, intra-articular, Fasitibant, MEN 16132
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasitibant- low doseDrug
Single intra-articular injection of low dose of fasitibant
Fasitibant- intermediate doseDrug
Single intra-articular injection of intermediate dose of fasitibant
Fasitibant- high doseDrug
Single intra-articular injection of high dose of fasitibant
Placebo comparatorDrug
Single intra-articular injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| Fasitibant low dose | Experimental | Drug: solution for intra-articular injection Receives: Drug: Fasitibant- low dose |
| Fasitibant intermediate dose | Experimental | Drug: solution for intra-articular injection Receives: Drug: Fasitibant- intermediate dose |
| Fasitibant high dose | Experimental | Drug: solution for intra-articular injection Receives: Drug: Fasitibant- high dose |
| PLACEBO | Placebo comparator | Drug: solution for intra-articular injection Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC A
The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.
Measured: from baseline up to 2 weeks after randomisation
Secondary outcomes (3)
Change in WOMAC INDEX
The WOMAC VA 3.1 Index score (WOMAC INDEX) is the sum of WOMAC A (total pain), WOMAC B (stiffness) and WOMAC C (functional impairment) subscores. The WOMAC INDEX score ranges from 0 to 2400 mm, with higher scores indicating higher disease burden.
Measured: from baseline up to 6 weeks after randomisation
Responder Rate According to OMERACT-OARSI Criteria
Percentage of responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society International criteria (OMERACT-OARSI criteria). Patients with at least 50 % improvement in pain or in function scores are considered responders. Alternatively, patients are considered responders if they show at least 20% improvement in at least two of the following scores: pain, function and Patients's Global Assessment (PGA) scores.
Measured: from baseline up to 6 weeks after randomisation
Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate
Response based on change ≥ 20 % from baseline for EQ-5D-5L index value
Measured: from baseline up to 6 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies 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
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karel Pavelka, Professor, Study chair, Institute of Rheumatology, Charles University Faculty Hospital, Na Slupi 4, 128 50 Prague 2, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205814
- Sponsor's protocol ID
- BKOS-04
- Other IDs
- 2013-004999-35
- Acronym
- ALBATROSS-3
- Status last verified
- Oct 2015
- First submitted
- 14 Jul 2014
- Last updated
- 3 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Placebo-controlled, Four Parallel Arm, Dose-finding Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Single Intra-articular Injections of Fasitibant in Patients With Symptomatic Osteoarthritis of the Knee.
- ClinicalTrials.gov ID
- NCT02205814
- Acronym / sponsor ID
- ALBATROSS-3 / BKOS-04
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Arthritis, WOMAC, Injections, intra-articular, Fasitibant, MEN 16132
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Menarini GroupIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Posted 16 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic osteoarthritis (OA) of the knee.
Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a total of 4 treatment arms. Each arm includes a single intra-articular injection of one of three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation ratio will be 1:1:1:1.
The primary efficacy variable will be the change of the Western Ontario and McMaster Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and clinical laboratory tests; local tolerability at the injection site will also be assessed. In addition, the population pharmacokinetics and the exposure-response relationship will be evaluated.
The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7 planned visits at site, including screening, randomisation, 4 follow-up visits and the End of study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fasitibant low dose | Experimental | Drug: Fasitibant- low doseDrug: solution for intra-articular injection |
| Fasitibant intermediate dose | Experimental | Drug: Fasitibant- intermediate doseDrug: solution for intra-articular injection |
| Fasitibant high dose | Experimental | Drug: Fasitibant- high doseDrug: solution for intra-articular injection |
| PLACEBO | Placebo comparator | Drug: Placebo comparatorDrug: solution for intra-articular injection |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients aged 40 to 80 years with BMI < 30 kg/m²
- Patient with Kellgren-Lawrence Grade 2 to 3, symptomatic primary osteoarthritis at the index knee (ACR criteria), for which an IA treatment is indicated
- Pain of moderate to severe intensity, even if treated with chronic doses of non steroidal antinflammatory drugs
Key exclusion criteria (12 listed)
- History of hypersensitivity/allergy to drugs including paracetamol and to disinfectants
- Any pharmacological treatment of concomitant disease(s) started or changed during 4 weeks prior to randomisation, or likely to be changed during the course of the study
- Use of systemic or topical corticosteroids > 10 mg prednisolone equivalent per day, or immunosuppressant drugs
- Current use of any pain or OA medication (e.g. NSAIDs, COX-2 inhibitors, analgesics, antidepressive agents), including topical treatments
- Viscosupplementation to the target knee administered < 4 months prior to randomisation and/or scheduled during the course of the study
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 |
|---|---|---|
| Fasitibant- low doseSingle intra-articular injection of low dose of fasitibant | Drug | Fasitibant low dose |
| Fasitibant- intermediate doseSingle intra-articular injection of intermediate dose of fasitibant | Drug | Fasitibant intermediate dose |
| Fasitibant- high doseSingle intra-articular injection of high dose of fasitibant | Drug | Fasitibant high dose |
| Placebo comparatorSingle intra-articular injection of placebo | Drug | PLACEBO |
Primary outcome
Change in WOMAC A
Time frame: from baseline up to 2 weeks after randomisation
The validated Western Ontario and McMaster University questionnaire (WOMAC) was used to measure total knee pain choosing its visual analogue scale version (VAS). The WOMAC VA 3.1 A subscore (WOMAC A) ranges from 0 to 500 mm (summing up five VAS 0-100 mm) with higher scores indicating more pain.
3 secondary outcomes
Change in WOMAC INDEX
Time frame: from baseline up to 6 weeks after randomisation
Responder Rate According to OMERACT-OARSI Criteria
Time frame: from baseline up to 6 weeks after randomisation
Euro Quality of Life Questionnaire (EQ-5D-5L) Responder Rate
Time frame: from baseline up to 6 weeks after randomisation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Karel Pavelka, Professor study chair
Institute of Rheumatology, Charles University Faculty Hospital, Na Slupi 4, 128 50 Prague 2, Czech Republic
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fasitibant- low dose, Fasitibant- intermediate dose and Fasitibant- high dose in people with Knee Osteoarthritis, run by Menarini Group at 25 sites in 4 countries.
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 3 inclusion and 12 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Italy, Germany, Czechia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in WOMAC A (time frame: from baseline up to 2 weeks after randomisation). 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 3 Nov 2015.