Osteoarthritis, KneePhase 2SPRINGBOARDNCT04120402
Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee
A Phase 2 study testing EP-104IAR 25 mg in people with Osteoarthritis, Knee, run by Eupraxia Pharmaceuticals Inc. at 12 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- EP-104IAR 25 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 318 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 10 Sep 2021to 1 Jun 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, aged ≥40 years
- Body Mass Index (BMI) ≤ 40.0 kg/m2
- Diagnosis of primary OA of the Index knee, with symptoms present for at least 6 months
- OA severity Grade 2 or 3 (based on Kellgren Lawrence Grading Scale)
- Unsatisfactory pain relief from at least 2 prior standard OA treatments
- Qualifying pain in the Index knee during the baseline period
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- Ambulatory (without the need for a cane/other walking aide)
- Female subjects willing to use highly effective birth control methods to prevent pregnancy
- Willing and able to comply with study procedures and restrictions, including abstaining from use of restricted medications.
Who cannot join
- OA of the Index knee due to acute injury or trauma, or unstable joint
- X-ray evidence of chondrocalcinosis
- Diagnosed or suspected ipsilateral hip OA
- Knee pain that is not attributable to OA of the knee
- Any other disorders that impact mobility, strength or sensation, or are a co-existent source of pain or inflammation that interfere with assessment of knee pain and function
- History of infection in the Index knee
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- Skin breakdown on the Index knee where the injection will take place
- Total Knee Replacement, or any other surgery (including arthroscopy) for the Index knee within prior 12 months, or planned surgery during the study
- Total Knee Replacement Surgery of the non-Index knee within prior 6 months, or planned surgery (any location) during the study that would require a restricted medication
- IA injection of corticosteroids in any joint within prior 3 months or IA injection of extended-release corticosteroids in any joint within prior 6 months
- IA injection in the Index knee of platelet rich plasma, or other prolotherapy within prior 3 months, or hyaluronic acid within prior 6 months
- Recent, current or planned use of corticosteroids for any indication (except for permitted uses)
- Recent, current or planned use of prohibited medications (including analgesics, marijuana, investigational drugs and devices, immunosuppressive therapy), or unwilling or unable to stop using prohibited medications during the study.
- Conditions including: sarcoidosis, amyloidosis, osteomyelitis, Cushing's Syndrome, hepatic or renal disease, Psychotic disorder, bipolar disorder, symptomatic depressive or anxiety disorders.
- Current malignancy of any type, or history of a malignancy within prior 12 months
- Active or quiescent systemic fungal, bacterial (including tuberculosis) viral (including HIV, Hepatitis B or C) or parasitic infections, or ocular herpes simplex, or any recent infection requiring IV or oral antibiotics
- Laboratory results indicative of adrenal insufficiency, diabetes or renal or hepatic disease.
- Positive urine drug screen for a substance of abuse
- Females who are pregnant, lactating
- Known or suspected hypersensitivity or contraindication to ingredients in the study drug
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Poland5 sites
NZOZ BIF-MED s.c
Bytom
Somed CR
Lodz
Medyczne Centrum Hetmańska
Poznan
DC-MED
Swidnica
Somed CR
Warsaw
Denmark4 sites
The Parker Institute, Frederiksberg Hospital
Frederiksberg
Sanos Clinic Nordjylland
Gandrup
Sanos Clinic Herlev
Herlev
Sanos Clinic Syddanmark
Vejle
Czechia3 sites
CCR Brno, s.r.o
Brno
CCR Czech a.s
Pardubice
CCR Prague, s.r.o
Prague
About this study
Official title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients With Osteoarthritis of the Knee
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single injection, 24-week study to evaluate the safety, efficacy and PK of EP-104IAR in subjects with osteoarthritis knee pain
Following screening and baseline assessments to determine eligibility, each participant will receive a single IA injection of either EP-104IAR or placebo (vehicle). Participants will be followed up for 24 weeks following the injection for safety, PK and efficacy assessments.
- Conditions
- Osteoarthritis, Knee
- Being tested
- EP-104IAR 25 mg, Vehicle
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP-104IAR 25 mgDrug
Single 5 mL intra-articular injection
VehicleDrug
Single 5 mL intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| EP-104IAR 25 mg | Experimental | A single use intra-articular injection containing 25 mg of EP-104IAR Receives: Drug: EP-104IAR 25 mg |
| Placebo (vehicle) | Placebo comparator | A single use intra-articular injection containing no active ingredients Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score.
Measured: 12 weeks
Secondary outcomes (4)
Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale (scores scaled 0-10, with 10 being the worst). Function subscale includes questions related to the physical functioning of osteoarthritis e.g. stair use, standing, walking etc. From a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC function score.
Measured: 12 weeks
Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale
Area under the curve in change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst) from Week 0 to Week 12 was calculated on a per-individual basis using the linear trapezoidal rule. AUC was normalized to account for subjects whose actual days and nominal days at Week 12 differed. Treatments were compared using an ANCOVA model containing site; individual baseline WOMAC Pain; and treatment group as covariates.
Measured: 12 weeks
Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score.
Measured: 24 weeks
Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders
Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) strict responders are defined as at least 50% improvement (decrease from baseline) in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain or function subscales (scores scaled 0-10, with 10 being the worst) and an absolute change of at least 2 in the respective score. Patients who discontinued prior to Week 12 were considered non-responders.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start10 Sep 2021
- Primary completion17 May 2023
- Study completion1 Jun 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to received either EP-104IAR or placebo (vehicle) in a parallel group fashion.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eupraxia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Responsible party
- Sponsor
- Investigators
- Amanda Malone, Study director, Eupraxia Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120402
- Sponsor's protocol ID
- EP-104IAR-201
- Acronym
- SPRINGBOARD
- Status last verified
- May 2024
- First submitted
- 7 Oct 2019
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malone A, Kowalski MM, Helliwell J, Lynggaard Boll S, Rovsing H, Moriat K, Castillo Mondragon A, Li Y, Prener Miller C, Reinstrup Bihlet A, Dobek C, Peck V, Wilmink M, Simon LS, Conaghan PG. Efficacy and safety of a diffusion-based extended-release fluticasone propionate intra-articular injection (EP-104IAR) in knee osteoarthritis (SPRINGBOARD): a 24-week, multicentre, randomised, double-blind, vehicle-controlled, phase 2 trial. Lancet Rheumatol. 2024 Dec;6(12):e860-e870. doi: 10.1016/S2665-9913(24)00223-6. Epub 2024 Oct 11.
PubMed 39401503
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Vehicle-Controlled Study Evaluating the Safety, Efficacy and Pharmacokinetics of Single Dose EP-104IAR for 24 Weeks in Patients With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT04120402
- Acronym / sponsor ID
- SPRINGBOARD / EP-104IAR-201
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Eupraxia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Collaborators
- NBCD A/S
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee
Detailed description
This is a randomized, double-blind, placebo-controlled, single injection, 24-week study to evaluate the safety, efficacy and PK of EP-104IAR in subjects with osteoarthritis knee pain
Following screening and baseline assessments to determine eligibility, each participant will receive a single IA injection of either EP-104IAR or placebo (vehicle). Participants will be followed up for 24 weeks following the injection for safety, PK and efficacy assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to received either EP-104IAR or placebo (vehicle) in a parallel group fashion.
| Arm | Type | Receives |
|---|---|---|
| EP-104IAR 25 mg | Experimental | Drug: EP-104IAR 25 mgA single use intra-articular injection containing 25 mg of EP-104IAR |
| Placebo (vehicle) | Placebo comparator | Drug: VehicleA single use intra-articular injection containing no active ingredients |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males or females, aged ≥40 years
- Body Mass Index (BMI) ≤ 40.0 kg/m2
- Diagnosis of primary OA of the Index knee, with symptoms present for at least 6 months
- OA severity Grade 2 or 3 (based on Kellgren Lawrence Grading Scale)
- Unsatisfactory pain relief from at least 2 prior standard OA treatments
Key exclusion criteria (20 listed)
- OA of the Index knee due to acute injury or trauma, or unstable joint
- X-ray evidence of chondrocalcinosis
- Diagnosed or suspected ipsilateral hip OA
- Knee pain that is not attributable to OA of the knee
- Any other disorders that impact mobility, strength or sensation, or are a co-existent source of pain or inflammation that interfere with assessment of knee pain and function
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-104IAR 25 mgSingle 5 mL intra-articular injection | Drug | EP-104IAR 25 mg |
| VehicleSingle 5 mL intra-articular injection | Drug | Placebo (vehicle) |
Primary outcome
Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale
Time frame: 12 weeks
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (scores scaled 0-10, with 10 being the worst). Least squares mean from a mixed model for repeated measures (MMRM) for change from baseline with fixed effects for site, treatment, week, treatment-by-week interaction; random effect for subject; and covariate baseline WOMAC pain score.
4 secondary outcomes
Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Function Subscale
Time frame: 12 weeks
Difference Between EP-104IAR and Vehicle in the Area Under the Curve (AUC) of WOMAC Pain Subscale
Time frame: 12 weeks
Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale
Time frame: 24 weeks
Difference Between EP-104IAR and Vehicle in OMERACT-OARSI Strict Responders
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39401503Malone A, Kowalski MM, Helliwell J, Lynggaard Boll S, Rovsing H, Moriat K, Castillo Mondragon A, Li Y, Prener Miller C, Reinstrup Bihlet A, Dobek C, Peck V, Wilmink M, Simon LS, Conaghan PG. Efficacy and safety of a diffusion-based extended-release fluticasone propionate intra-articular injection (EP-104IAR) in knee osteoarthritis (SPRINGBOARD): a 24-week, multicentre, randomised, double-blind, vehicle-controlled, phase 2 trial. Lancet Rheumatol. 2024 Dec;6(12):e860-e870. doi: 10.1016/S2665-9913(24)00223-6. Epub 2024 Oct 11.
- Individual participant dataSharing planned: No
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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.
Amanda Malone study director
Eupraxia Pharmaceuticals
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EP-104IAR 25 mg in people with Osteoarthritis, Knee, run by Eupraxia Pharmaceuticals Inc. at 12 sites in 3 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 9 inclusion and 20 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Poland, Denmark, 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 25 Jun 2024). 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?
Difference in Change From Baseline Between EP-104IAR and Vehicle in WOMAC Pain Subscale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120402, which also lists 1 linked publication.
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 25 Jun 2024.