Osteoarthritis, KneePhase 1STEPUPNCT02609126
Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis
A Phase 1 study testing EP-104IAR in people with Osteoarthritis, Knee, run by Eupraxia Pharmaceuticals Inc. at 3 sites in Canada.
Trial summary
The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- EP-104IAR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 3 sitesCanada
- Study dates
- Apr 2016to 28 Dec 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OA of Index Knee
- Kellgren Lawrence Grade 2 or 3
- Patient-reported pain (PtPain) of Index Knee ≥4 but ≤9
- PtPain of non-Index Knee <6
- BMI ≦ 40 kg/m2
Who cannot join
- Intra-articular joint injection in the Index Knee within the past 8 weeks for glucocorticoids and 6 months for hyaluronic acid
- Insulin-dependent diabetes
- Active infection
- Pregnant or breast feeding
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Centre for Studies in Family Medicine
London, Ontario, N6A 3K7
Fowler Kennedy Sports Medicine Clinic
London, Ontario, N6A 3K7
Rebalance MD
Victoria, British Columbia
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Trial Evaluating the Pharmacokinetics, Safety and Preliminary Efficacy of EP-104IAR (Long-Acting Fluticasone Propionate) in Patients With Osteoarthritis of the Knee
The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee.
Osteoarthritis is the most common joint disease, affecting over 20 million people in the US alone. Currently, pain treatments that are injected directly into the knee often work for only a short time and may also have side effects within the rest of the body. The experimental treatment is a steroid that is in the same family of drugs as the most common current injectable treatments for knee osteoarthritis. For this study, the drug is coated with a polymer intended to prolong the time it stays inside the knee and lessen potential side effects.
- Conditions
- Osteoarthritis, Knee
- Being tested
- EP-104IAR, Vehicle
- Keywords
- osteoarthritis, knee
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP-104IARDrug
Single, ultrasound-guided injection of EP-104IAR into the knee
VehicleDrug
Single, ultrasound-guided injection of vehicle placebo into the knee
| Study group | Role | What they receive |
|---|---|---|
| EP-104IAR | Experimental | 15mg EP-104IAR in 4 mL carrier fluid Receives: Drug: EP-104IAR |
| Vehicle | Placebo comparator | 4 mL carrier fluid Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax) of fluticasone propionate
Measured: Up to 42 weeks
Fluticasone propionate concentrations in synovial fluid
Measured: Up to 30 weeks
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
Measured: 12 weeks
Incidence of treatment-emergent adverse events
Measured: Up to 42 weeks
Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis
Measured: Up to 42 weeks
Secondary outcomes (6)
Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee
Measured: Weekly up to 42 weeks
Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee
Measured: Weekly up to 42 weeks
Change from baseline in patient-reported Global Assessment of Arthritis
Measured: Up to 42 weeks
Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: Up to 42 weeks
Change from baseline in patient-reported Short Form - 36 quality of life scores
Measured: Up to 42 weeks
Change from baseline in Physician's Global Assessment of Arthritis
Measured: Up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startApr 2016
- Primary completion28 Dec 2017
- Study completion28 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eupraxia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syreon Corporation
- Responsible party
- Sponsor
- Investigators
- James Helliwell, MD FRCPC, Study director, Eupraxia Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609126
- Sponsor's protocol ID
- EP-104IAR-101
- Acronym
- STEPUP
- Status last verified
- Aug 2021
- First submitted
- 17 Nov 2015
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase I Trial Evaluating the Pharmacokinetics, Safety and Preliminary Efficacy of EP-104IAR (Long-Acting Fluticasone Propionate) in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02609126
- Acronym / sponsor ID
- STEPUP / EP-104IAR-101
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eupraxia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syreon Corporation
- Study start
- Apr 2016 (actual)
- Primary completion
- 28 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 20 Nov 2015 (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.
The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee.
Osteoarthritis is the most common joint disease, affecting over 20 million people in the US alone. Currently, pain treatments that are injected directly into the knee often work for only a short time and may also have side effects within the rest of the body. The experimental treatment is a steroid that is in the same family of drugs as the most common current injectable treatments for knee osteoarthritis. For this study, the drug is coated with a polymer intended to prolong the time it stays inside the knee and lessen potential side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP-104IAR | Experimental | Drug: EP-104IAR15mg EP-104IAR in 4 mL carrier fluid |
| Vehicle | Placebo comparator | Drug: Vehicle4 mL carrier fluid |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- OA of Index Knee
- Kellgren Lawrence Grade 2 or 3
- Patient-reported pain (PtPain) of Index Knee ≥4 but ≤9
- PtPain of non-Index Knee <6
- BMI ≦ 40 kg/m2
Key exclusion criteria (4 listed)
- Intra-articular joint injection in the Index Knee within the past 8 weeks for glucocorticoids and 6 months for hyaluronic acid
- Insulin-dependent diabetes
- Active infection
- Pregnant or breast feeding
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 |
|---|---|---|
| EP-104IARSingle, ultrasound-guided injection of EP-104IAR into the knee | Drug | EP-104IAR |
| VehicleSingle, ultrasound-guided injection of vehicle placebo into the knee | Drug | Vehicle |
Primary outcome
Peak Plasma Concentration (Cmax) of fluticasone propionate
Time frame: Up to 42 weeks
Fluticasone propionate concentrations in synovial fluid
Time frame: Up to 30 weeks
Area under the plasma concentration versus time curve (AUC) of fluticasone propionate
Time frame: 12 weeks
Incidence of treatment-emergent adverse events
Time frame: Up to 42 weeks
Change from baseline in clinical laboratory parameters: hematology, chemistry (including cortisol) and urinalysis
Time frame: Up to 42 weeks
6 secondary outcomes
Time to baseline pain in patient-reported Pain Numerical Rating Scale for Index knee
Time frame: Weekly up to 42 weeks
Change from baseline in patient-reported Pain Numerical Rating Scale for Index knee
Time frame: Weekly up to 42 weeks
Change from baseline in patient-reported Global Assessment of Arthritis
Time frame: Up to 42 weeks
Change from baseline in patient-reported Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Up to 42 weeks
Change from baseline in patient-reported Short Form - 36 quality of life scores
Time frame: Up to 42 weeks
Change from baseline in Physician's Global Assessment of Arthritis
Time frame: Up to 42 weeks
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 1 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
James Helliwell, MD FRCPC study director
Eupraxia Pharmaceuticals
3 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 EP-104IAR in people with Osteoarthritis, Knee, run by Eupraxia Pharmaceuticals Inc. at 3 sites in Canada.
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 5 inclusion and 4 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 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?
Peak Plasma Concentration (Cmax) of fluticasone propionate (time frame: Up to 42 weeks). The study lists 5 primary outcomes in all. 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 1 Sep 2021.