Knee OsteoarthritisPhase 2NCT01925261
A Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees
A Phase 2 study testing TPX-100 50mg, TPX-100 100mg and TPX-100 200mg in people with Knee Osteoarthritis, run by OrthoTrophix, Inc at 1 site in United States.
Trial summary
This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee cartilage in subjects with bilateral osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- TPX-100 50mg, TPX-100 100mg and TPX-100 200mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2016
- Phase
- Phase 2
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 25 and ≤ 75
- Patello-femoral osteoarthritis of both knees of mild to moderate severity with intact meniscus and ligamentous stability (cruciate and collateral ligaments)
- Clinically, as determined by screening questionnaire and judgment of the Principal Investigator (may be supported by imaging studies of knees); confirmed by centrally read screening MRI of both knees indicating ICRS Grade 1-3, or ICRS Grade 4 with only focal defects, no greater than 1 cm.
- Meniscus intact (MRI degenerative signal up to and including grade II acceptable)
- Cruciate and collateral ligament stability as defined by clinical examination
- Able to read, understand, sign and date the subject informed consent
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- Willingness to use only acetaminophen as the primary analgesic (pain-relieving) study medication. The maximum dose of acetaminophen must not exceed 4 grams/day (4000 mg per day).
- Willingness to use only hydrocodone/acetaminophen for breakthrough pain during the injection period (through study day 30).
- Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen, naproxen for the first 30 days of the study.
- Female subjects of child bearing potential who are sexually active (non-abstinent) must agree to and comply with using 2 highly effective methods of birth control (oral contraceptive, implant, injectable or indwelling intrauterine device, condom with spermicide, or sexual abstinence) while participating in the study.
Who cannot join
- Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
- ICRS grade greater than Grade 3, or Grade 4 focal defects greater than 1 cm, as confirmed by centrally-read screening MRI
- MRI evidence of inflammatory or hypertrophic synovitis
- Prior surgery in the knees, excluding procedures for debridement only (no microfracture)
- Joint replacement or any other knee surgery planned in the next 12 months
- History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
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- Knee effusion >2+ on the following clinical scale:
- Zero = No wave produced on downstroke
- Trace = Small wave on medial side with downstroke
- 1+ = Larger bulge on medial side with downstroke
- 2+ = Effusion spontaneously returns to medial side after upstroke (no downstroke necessary)
- 3+ = So much fluid that it is not possible to move the effusion out of the medial aspect of the knee
- Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before screening
- Last intra-articular knee injection of corticosteroids < 2 months before screening
- Use of any steroids (except inhaled corticosteroids for respiratory problems) during the previous month before screening
- Known hypersensitivity to TPX-100
- Known hypersensitivity to acetaminophen or hydrocodone
- History of arthroscopy in either knee in the last 3 months before screening
- History of septic arthritis, gout or pseudo-gout, of either knee in previous year before screening
- Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
- Patellar chondrocalcinosis on X-Ray
- Skin problem, rash or hypersensitivity, affecting either knee at the injection site
- Bleeding problem, platelet or coagulation deficiency contraindicating, in the doctor's opinion, any intra-articular injection
- Active systemic infection
- Current treatment or treatment within the previous 2 years prior to the Screening Visit for any malignancy except basal cell or squamous cell carcinoma of the skin, unless with specific written permission is provided by the Sponsor's medical monitor
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
- Participation in other clinical osteoarthritis drug studies within one year prior to screening
- Currently taking Paclitaxel (mitotic inhibitor), and or Natalizumab (anti-integrin monoclonal antibody).
- History of significant liver disease or consumption of more than 3 alcoholic drinks a day. (Definition of one alcoholic drink: 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor such as gin, rum, vodka, or whiskey).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees
This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee cartilage in subjects with bilateral osteoarthritis of the knee.
- Conditions
- Knee Osteoarthritis
- Being tested
- TPX-100 50mg, TPX-100 100mg, TPX-100 200mg, TPX-100 20mg, Placebo
- Keywords
- knee osteoarthritis, bilateral, osteoarthritis
- 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.
TPX-100 50mgDrug
Also called 50mg of TPX-100
TPX-100 100mgDrug
Also called 100mg of TPX-100
TPX-100 200mgDrug
Also called 200mg of TPX-100
TPX-100 20mgDrug
Also called 20mg of TPX-100
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TPX-100 Cohort 1 | Placebo comparator | Cohort 1 will be 20mg dose of TPX-100 in one randomized knee, compared to placebo treated knee Receives: Drug: TPX-100 20mg; Drug: Placebo |
| TPX-100 Cohort 2 | Placebo comparator | Cohort 2 will be 50mg dose of TPX-100 in one randomized knee compared to placebo treated knee Receives: Drug: TPX-100 50mg; Drug: Placebo |
| TPX-100 Cohort 3 | Placebo comparator | Cohort 3 will be 100mg dose of TPX-100 in one randomized knee compared to placebo treated knee Receives: Drug: TPX-100 100mg; Drug: Placebo |
| TPX-100 Cohort 4 | Placebo comparator | Cohort 4 will be 200mg dose of TPX-100 in one randomized knee, compared to placebo treated knee Receives: Drug: TPX-100 200mg; Drug: Placebo |
| Part B | Placebo comparator | Part B will be 200mg dose of TPX-100 in one randomized knee, compared to placebo treated knee Receives: Drug: TPX-100 200mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cartilage thickness in the patello-femoral compartment as measured on standardized MRI from baseline to 12 months
Change in cartilage thickness in the patello-femoral compartment from baseline to 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionSep 2016
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 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoTrophix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925261
- Sponsor's protocol ID
- TPX-100
- Status last verified
- May 2015
- First submitted
- 15 Aug 2013
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McGuire D, Bowes M, Brett A, Segal NA, Miller M, Rosen D, Kumagai Y. Study TPX-100-5: intra-articular TPX-100 significantly delays pathological bone shape change and stabilizes cartilage in moderate to severe bilateral knee OA. Arthritis Res Ther. 2021 Sep 17;23(1):242. doi: 10.1186/s13075-021-02622-8.
PubMed 34535197
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees
- ClinicalTrials.gov ID
- NCT01925261
- Acronym / sponsor ID
- TPX-100
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, bilateral, osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- OrthoTrophix, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Aug 2013 (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.
This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee cartilage in subjects with bilateral osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TPX-100 Cohort 1 | Placebo comparator | Drug: TPX-100 20mg, Drug: PlaceboCohort 1 will be 20mg dose of TPX-100 in one randomized knee, compared to placebo treated knee |
| TPX-100 Cohort 2 | Placebo comparator | Drug: TPX-100 50mg, Drug: PlaceboCohort 2 will be 50mg dose of TPX-100 in one randomized knee compared to placebo treated knee |
| TPX-100 Cohort 3 | Placebo comparator | Drug: TPX-100 100mg, Drug: PlaceboCohort 3 will be 100mg dose of TPX-100 in one randomized knee compared to placebo treated knee |
| TPX-100 Cohort 4 | Placebo comparator | Drug: TPX-100 200mg, Drug: PlaceboCohort 4 will be 200mg dose of TPX-100 in one randomized knee, compared to placebo treated knee |
| Part B | Placebo comparator | Drug: TPX-100 200mg, Drug: PlaceboPart B will be 200mg dose of TPX-100 in one randomized knee, compared to placebo treated knee |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 25 and ≤ 75
- Patello-femoral osteoarthritis of both knees of mild to moderate severity with intact meniscus and ligamentous stability (cruciate and collateral ligaments)
- Able to read, understand, sign and date the subject informed consent
- Willingness to use only acetaminophen as the primary analgesic (pain-relieving) study medication. The maximum dose of acetaminophen must not exceed 4 grams/day (4000 mg per day).
- Willingness to use only hydrocodone/acetaminophen for breakthrough pain during the injection period (through study day 30).
Key exclusion criteria (29 listed)
- Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
- ICRS grade greater than Grade 3, or Grade 4 focal defects greater than 1 cm, as confirmed by centrally-read screening MRI
- MRI evidence of inflammatory or hypertrophic synovitis
- Prior surgery in the knees, excluding procedures for debridement only (no microfracture)
- Joint replacement or any other knee surgery planned in the next 12 months
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 |
|---|---|---|
| TPX-100 50mgAlso: 50mg of TPX-100 | Drug | TPX-100 Cohort 2 |
| TPX-100 100mgAlso: 100mg of TPX-100 | Drug | TPX-100 Cohort 3 |
| TPX-100 200mgAlso: 200mg of TPX-100 | Drug | Part B, TPX-100 Cohort 4 |
| TPX-100 20mgAlso: 20mg of TPX-100 | Drug | TPX-100 Cohort 1 |
| Placebo | Drug | Part B, TPX-100 Cohort 1, TPX-100 Cohort 2, TPX-100 Cohort 3, TPX-100 Cohort 4 |
Primary outcome
Change in cartilage thickness in the patello-femoral compartment as measured on standardized MRI from baseline to 12 months
Time frame: 12 months
Change in cartilage thickness in the patello-femoral compartment from baseline to 12 months
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 21 Apr 2017.
- Derived from this study: PubMed 34535197McGuire D, Bowes M, Brett A, Segal NA, Miller M, Rosen D, Kumagai Y. Study TPX-100-5: intra-articular TPX-100 significantly delays pathological bone shape change and stabilizes cartilage in moderate to severe bilateral knee OA. Arthritis Res Ther. 2021 Sep 17;23(1):242. doi: 10.1186/s13075-021-02622-8.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPX-100 50mg, TPX-100 100mg and TPX-100 200mg in people with Knee Osteoarthritis, run by OrthoTrophix, Inc at 1 site 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 10 inclusion and 29 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 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
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?
Change in cartilage thickness in the patello-femoral compartment as measured on standardized MRI from baseline to 12 months (time frame: 12 months). 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 NCT01925261, 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 21 Apr 2017.