Back to results

3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee

Primary Purpose

Osteoarthritis of the Knee

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lorecivivint

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring SM04690, Wnt pathway inhibitor, osteoarthritis, Biosplice Therapeutics, Inc., Lorecivivint

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA
Femorotibial OA by standard American College of Rheumatology (ACR) criteria; knee OA is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis).
Pain compatible with knee OA for at least 26 weeks prior to the Screening Visit
Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, and benzodiazepine, unless any of these drugs are prescribed by a physician to treat a specific condition
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed

Exclusion Criteria:

Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at Screening and Day 1
Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control during the study period
Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
Intra-articular (IA) injection into either knee with a therapeutic aim including, but not limited to, hyaluronic acid, platelet-rich plasma (PRP), and stem cell therapies within 26 weeks prior to Day 1 or IA glucocorticoids within 12 weeks prior to Day 1
Any condition 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
Any comorbid condition that could affect study endpoint assessments of the knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
Any contraindications for an IA injection in the knee(s) to be injected at Day 1 in the opinion of the Investigator

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.07 mg Lorecivivint

Arm Description

One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.

Outcomes

Primary Outcome Measures

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

AEs that occur during the study will be recorded. All AEs will be evaluated for severity, seriousness and causal relationship to study medication.

Secondary Outcome Measures

Change from baseline in pain numeric rating scale (NRS) score for the knee

Change from baseline in pain numeric rating scale (NRS) score for the knee. The pain NRS is an 11-point scale [0-10] for subject self-reporting of average knee pain in the last 24 hours; 0 indicates no pain, and 10 represents the worst possible pain.

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function)

Change from baseline OA function in the target knee as assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function). The WOMAC is a widely-used, proprietary outcome measurement tool used to evaluate the condition of subjects with OA of the knee and hip, including pain, stiffness, and physical functioning of a target joint. Each question is measured on a scale from 0 (lowest pain/lowest stiffness/highest function) to 4 (highest pain/highest stiffness/lowest function). The WOMAC Function subscore ranges from 0 to 68 (raw) and will be scaled 0 to 100 for reporting.

Full Information

NCT ID

NCT04931667

First Posted

June 4, 2021

Last Updated

December 17, 2021

Sponsor

Biosplice Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04931667

Brief Title

3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee

Official Title

A 3-Year, Multicenter, Open-Label Study Evaluating the Safety, Tolerability, and Efficacy of Intra-articular Lorecivivint in Subjects With Osteoarthritis of the Knee in a Real-World Setting (STRIDES-EXTRA)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated due to business reasons by Sponsor.

Study Start Date

July 15, 2021 (Actual)

Primary Completion Date

December 13, 2021 (Actual)

Study Completion Date

December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosplice Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is designed as a 3-year, multicenter, open-label study evaluating the safety, tolerability, and efficacy of intra-articular (IA) Lorecivivint (LOR) in subjects with osteoarthritis of the knee in a real-world setting.

Detailed Description

At Day 1, after a screening period of up to 14 days, subjects will receive an IA injection of 0.07 mg LOR into one or both knees, followed by a 36-month evaluation period. Clinic visits will be scheduled at Day 1, and Months 3, 12, 24, and 36 [End of study (EOS)] or Early Termination (ET) for completion of all Patient Reported Outcome (PRO) measurements Western Ontario and McMaster University Arthritis Index (WOMAC), Knee Injury and Ostheoarthritis Outcome Score (KOOS), pain Numeric Rating Scale (NRS), Study Form (SF)-12, Patient Acceptable Symptom State Questionnaire (PASS), Work Productivity and Activity Impairment Questionnaire (WPAI)], functional tests [40-meter walk test and Time Up and Go (TUG) test at a subset of sites], and safety evaluations. On Day 1, the Charlson Comorbidity Index and Widespread Pain Index and Symptom Severity [WPI&SS] assessments will also be completed. A phone visit for safety follow-up will occur 4 weeks after the injection on Day 1. Subjects may also have Unscheduled Injection Visits for additional injections of LOR, glucocorticoid, or hyaluronic acid (HA). Following each injection, subjects will return to the clinic for 3-Month Post-Injection Follow-Up Visits, unless another visit has occurred between the injection and the 3-month post injection date. At these injection visits and 3-Month Post-Injection Follow-Up Visits, subjects will complete PRO measurements and functional tests (at a subset of sites).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

Keywords

SM04690, Wnt pathway inhibitor, osteoarthritis, Biosplice Therapeutics, Inc., Lorecivivint

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.07 mg Lorecivivint

Arm Type

Experimental

Arm Description

One intra-articular injection of 0.07 mg Lorecivivint in 2 ml vehicle in one or both knees as clinically indicated. Bilateral injection of 0.07 mg LOR are allowed.

Intervention Type

Drug

Intervention Name(s)

Lorecivivint

Other Intervention Name(s)

SM04690

Intervention Description

Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.

Primary Outcome Measure Information:

Title

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Description

AEs that occur during the study will be recorded. All AEs will be evaluated for severity, seriousness and causal relationship to study medication.

Time Frame

From Study Day 1 through Subject's last visit, Early Termination (ET) or End of Study (EOS), up to 36 months.

Secondary Outcome Measure Information:

Title

Change from baseline in pain numeric rating scale (NRS) score for the knee

Description

Time Frame

3 months after each injection (planned and unscheduled) monitored throughout the study for up to 36 months

Title

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function subscore (WOMAC Function)

Description

Time Frame

3 months after each injection (planned and unscheduled) monitored throughout the study for up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and females between 40 and 80 years of age, inclusive, in general good health apart from their knee OA Femorotibial OA by standard American College of Rheumatology (ACR) criteria; knee OA is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis). Pain compatible with knee OA for at least 26 weeks prior to the Screening Visit Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates, phencyclidine (PCP), propoxyphene, barbiturates, and benzodiazepine, unless any of these drugs are prescribed by a physician to treat a specific condition Full understanding of the requirements of the study and willingness to comply with all study visits and assessments Subjects must have read and understood the informed consent form (ICF), and must have signed and dated it prior to any study-related procedure being performed Exclusion Criteria: Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at Screening and Day 1 Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control during the study period Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1 Intra-articular (IA) injection into either knee with a therapeutic aim including, but not limited to, hyaluronic acid, platelet-rich plasma (PRP), and stem cell therapies within 26 weeks prior to Day 1 or IA glucocorticoids within 12 weeks prior to Day 1 Any condition 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 Any comorbid condition that could affect study endpoint assessments of the knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia Any contraindications for an IA injection in the knee(s) to be injected at Day 1 in the opinion of the Investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yusuf Yazici, MD

Organizational Affiliation

Biosplice Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Research Site

City

Oak Brook

State/Province

Illinois

ZIP/Postal Code

60523

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

3-year, Open-Label Study Evaluating Safety, Tolerability, and Efficacy of Lorecivivint in Subjects With Osteoarthritis of the Knee

We'll reach out to this number within 24 hrs