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

NCT01925261 | Completed Phase 2 DMC

• 1 other identifier: TPX-100
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; bilateral; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Study Arms (5)

TPX-100 Cohort 1

PLACEBO COMPARATOR

Cohort 1 will be 20mg dose of TPX-100 in one randomized knee, compared to placebo treated knee

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

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

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

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

Drug: TPX-100 200mg; Drug: Placebo

Interventions

TPX-100 50mg DRUG

Also known as: 50mg of TPX-100

TPX-100 Cohort 2

TPX-100 100mg DRUG

Also known as: 100mg of TPX-100

TPX-100 Cohort 3

TPX-100 200mg DRUG

Also known as: 200mg of TPX-100

Part B; TPX-100 Cohort 4

TPX-100 20mg DRUG

Also known as: 20mg of TPX-100

TPX-100 Cohort 1

Placebo DRUG

Part B; TPX-100 Cohort 1; TPX-100 Cohort 2; TPX-100 Cohort 3; TPX-100 Cohort 4

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• Knee effusion \>2+ on the following clinical scale:
• Zero = No wave produced on downstroke
• Trace = Small wave on medial side with downstroke
• + = Larger bulge on medial side with downstroke
• + = Effusion spontaneously returns to medial side after upstroke (no downstroke necessary)
• + = 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

Sponsors & Collaborators

• OrthoTrophix, Inc: lead

Study Sites (1)

C3 Clinical Research Associates

Seattle, Washington, United States

Location

Related Publications (1)

• 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.

  PMID: 34535197 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 21, 2017

Record last verified: 2015-05

Locations

US (1)