Moderate to Severe OsteoarthritisPhase 1NCT02095548
Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)
A Phase 1 study testing SM04690, 0.03mg/2mL, SM04690, 0.07mg/2mL and SM04690, 0.23mg/2mL in people with Moderate to Severe Osteoarthritis, run by Biosplice Therapeutics, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Moderate to Severe Osteoarthritis
- What is being tested?
- SM04690, 0.03mg/2mL, SM04690, 0.07mg/2mL and SM04690, 0.23mg/2mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2014to Sep 2015
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria
- Screening pain criteria sufficient as assessed by WOMAC and VAS scores
- Ability to read and understand the informed consent
Who cannot join
- Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception
- Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
- Body mass index >40
- Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period
- History of malignancy within the last 5 years
- Participation in a clinical research trial within 12 weeks prior
Show all 12Show fewer
- Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months
- Effusion of the target knee requiring aspiration within 3 months
- Use of electrotherapy or acupuncture for OA within 4 weeks
- Significant and clinically evident misalignment of the target knee
- Any known active infections
- Any chronic condition that has not been well controlled for a minimum of 3 months
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Boston, Massachusetts
Study site
Dallas, Texas
Study site
Duncansville, Pennsylvania
Study site
El Cajon, California
Study site
Miami, Florida
Study site
Tucson, Arizona
Study site
Walnut Creek, California
About this study
Official title: A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
- Conditions
- Moderate to Severe Osteoarthritis
- Being tested
- SM04690, 0.03mg/2mL, SM04690, 0.07mg/2mL, SM04690, 0.23mg/2mL, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SM04690, 0.03mg/2mLDrug
SM04690, 0.07mg/2mLDrug
SM04690, 0.23mg/2mLDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| SM04690, 0.03mg/2mL | Experimental | Single, intra-articular injection of SM04690, 0.03mg/2mL Receives: Drug: SM04690, 0.03mg/2mL |
| SM04690, 0.07mg/2mL | Experimental | Single, intra-articular injection of SM04690, 0.07mg/2mL Receives: Drug: SM04690, 0.07mg/2mL |
| SM04690, 0.23mg/2mL | Experimental | Single, intra-articular injection of SM04690, 0.23mg/2mL Receives: Drug: SM04690, 0.23mg/2mL |
| Placebo | Placebo comparator | Single, intra-articular injection of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments for this study will include adverse events, dose limiting toxicity (DLT), physical exams, vital signs, ECGs, and clinical laboratory tests
Measured: during 24 weeks
Additional safety assessment of bone loss as measured by CT of the knee
Measured: during 24 weeks
The following PK parameters will be determined from the plasma of SM04690; Cmax, Tmax, AUC0-t, AUC0-∞, and t1/2
Measured: during 12 weeks
Secondary outcomes (6)
Change from baseline pain over the last 48 hours using a Visual Analog Scale (VAS)
Measured: during 24 weeks
Change from baseline per Western Ontario and McMaster Osteoarthritis (WOMAC) assessment of disease scale
Measured: During 24 weeks
Change from baseline per physician global assessment of disease scale
Measured: during 24 weeks
Change from baseline in joint space width as measured by X-ray
Measured: during 24 weeks
Change from baseline of cartilage volume and thickness as measure by MRI
Measured: during 24 weeks
Change from baseline of biomarkers of cartilage synthesis and cytokines
Measured: during 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosplice Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095548
- Sponsor's protocol ID
- SM04690-01
- Status last verified
- Dec 2015
- First submitted
- 18 Mar 2014
- Last updated
- 10 Dec 2015
- Results posted
- No
Publications
Yazici Y, McAlindon TE, Fleischmann R, Gibofsky A, Lane NE, Kivitz AJ, Skrepnik N, Armas E, Swearingen CJ, DiFrancesco A, Tambiah JRS, Hood J, Hochberg MC. A novel Wnt pathway inhibitor, SM04690, for the treatment of moderate to severe osteoarthritis of the knee: results of a 24-week, randomized, controlled, phase 1 study. Osteoarthritis Cartilage. 2017 Oct;25(10):1598-1606. doi: 10.1016/j.joca.2017.07.006. Epub 2017 Jul 13.
PubMed 28711582
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
- ClinicalTrials.gov ID
- NCT02095548
- Acronym / sponsor ID
- SM04690-01
- Conditions
- Moderate to Severe Osteoarthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Biosplice Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 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.
The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SM04690, 0.03mg/2mL | Experimental | Drug: SM04690, 0.03mg/2mLSingle, intra-articular injection of SM04690, 0.03mg/2mL |
| SM04690, 0.07mg/2mL | Experimental | Drug: SM04690, 0.07mg/2mLSingle, intra-articular injection of SM04690, 0.07mg/2mL |
| SM04690, 0.23mg/2mL | Experimental | Drug: SM04690, 0.23mg/2mLSingle, intra-articular injection of SM04690, 0.23mg/2mL |
| Placebo | Placebo comparator | Drug: PlaceboSingle, intra-articular injection of placebo |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria
- Screening pain criteria sufficient as assessed by WOMAC and VAS scores
- Ability to read and understand the informed consent
Key exclusion criteria (12 listed)
- Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception
- Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
- Body mass index >40
- Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period
- History of malignancy within the last 5 years
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 |
|---|---|---|
| SM04690, 0.03mg/2mL | Drug | SM04690, 0.03mg/2mL |
| SM04690, 0.07mg/2mL | Drug | SM04690, 0.07mg/2mL |
| SM04690, 0.23mg/2mL | Drug | SM04690, 0.23mg/2mL |
| Placebo | Drug | Placebo |
Primary outcome
Safety assessments for this study will include adverse events, dose limiting toxicity (DLT), physical exams, vital signs, ECGs, and clinical laboratory tests
Time frame: during 24 weeks
Additional safety assessment of bone loss as measured by CT of the knee
Time frame: during 24 weeks
The following PK parameters will be determined from the plasma of SM04690; Cmax, Tmax, AUC0-t, AUC0-∞, and t1/2
Time frame: during 12 weeks
6 secondary outcomes
Change from baseline pain over the last 48 hours using a Visual Analog Scale (VAS)
Time frame: during 24 weeks
Change from baseline per Western Ontario and McMaster Osteoarthritis (WOMAC) assessment of disease scale
Time frame: During 24 weeks
Change from baseline per physician global assessment of disease scale
Time frame: during 24 weeks
Change from baseline in joint space width as measured by X-ray
Time frame: during 24 weeks
Change from baseline of cartilage volume and thickness as measure by MRI
Time frame: during 24 weeks
Change from baseline of biomarkers of cartilage synthesis and cytokines
Time frame: during 24 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 10 Dec 2015.
- Derived from this study: PubMed 28711582Yazici Y, McAlindon TE, Fleischmann R, Gibofsky A, Lane NE, Kivitz AJ, Skrepnik N, Armas E, Swearingen CJ, DiFrancesco A, Tambiah JRS, Hood J, Hochberg MC. A novel Wnt pathway inhibitor, SM04690, for the treatment of moderate to severe osteoarthritis of the knee: results of a 24-week, randomized, controlled, phase 1 study. Osteoarthritis Cartilage. 2017 Oct;25(10):1598-1606. doi: 10.1016/j.joca.2017.07.006. Epub 2017 Jul 13.
Related trials for Moderate to Severe Osteoarthritis
Recruiting
Patient Pain and Function in Medial Knee Osteoarthritis After Anteromedial vs Anterolateral Intra-Articular Corticosteroid Injection
Osteoarthitis, Osteoarthritic Knee Pain
RecruitingPhase 1/2
Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis
Osteoarthritis of the Knees
Recruiting
Percutaneous Neurostimulation in Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Neuromodulation
Active, not recruiting
Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
Knee Osteoarthritis
RecruitingPhase 2
An Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
Osteoarthritis, Osteo Arthritis Knee
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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 SM04690, 0.03mg/2mL, SM04690, 0.07mg/2mL and SM04690, 0.23mg/2mL in people with Moderate to Severe Osteoarthritis, run by Biosplice Therapeutics, Inc. at 7 sites in United States.
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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Safety assessments for this study will include adverse events, dose limiting toxicity (DLT), physical exams, vital signs, ECGs, and clinical laboratory tests (time frame: during 24 weeks). The study lists 3 primary outcomes in all. 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 NCT02095548, 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 10 Dec 2015.