Overview

This trial is active, not recruiting.

Condition osteoarthritis, knee
Treatments as902330 100 microgram (mcg), as902330 30 microgram (mcg), placebo
Phase phase 2
Sponsor EMD Serono
Collaborator Nordic Bioscience A/S
Start date July 2013
End date May 2016
Trial size 549 participants
Trial identifier NCT01919164, 2011-003059-20, EMR700692_006

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of AS902330 administered intra-articularly in subjects with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial is intended to investigate the efficacy and safety of different intra articular dosages of AS902330 (Sprifermin) in these individuals.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
AS902330 will be administered at a dose of 100 microgram (mcg) in 4 cycles, wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
as902330 100 microgram (mcg) Sprifermin
AS902330 will be administered at a dose of 100 mcg in 4 cycles (at Baseline and Months 6, 12, and 18), wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
(Experimental)
AS902330, 100 mcg, will be administered in Cycles 1 and 3 and matching placebo will be administered in Cycles 2 and 4, wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
as902330 100 microgram (mcg) Sprifermin
AS902330 will be administered at a dose of 100 mcg in 2 cycles (at Baseline and Month 12), wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
placebo
Matching placebo will be administered in 2 cycles (at Months 6 and 18), wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
(Experimental)
AS902330 will be administered at a dose of 30 microgram (mcg) in 4 cycles, wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
as902330 30 microgram (mcg) Sprifermin
AS902330 will be administered at a dose of 30 mcg in 4 cycles (at Baseline and Months 6, 12, and 18), wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
(Experimental)
AS902330, 30 mcg, will be administered in Cycles 1 and 3 and matching placebo will be administered in Cycles 2 and 4, wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
as902330 30 microgram (mcg) Sprifermin
AS902330 will be administered at a dose of 30 mcg in 2 cycles (at Baseline and Month 12), wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
placebo
Matching placebo will be administered in 2 cycles (at Months 6 and 18), wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
(Placebo Comparator)
Matching Placebo will be administered in 4 cycles, wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.
placebo
Matching placebo will be administered in 4 cycles (at Baseline and Months 6, 12, and 18), wherein each cycle will include 3 once-weekly intra-articular injections over a period of 3 consecutive weeks, with follow-up to 2 years.

Primary Outcomes

Measure
Change from Baseline in cartilage thickness in the total femorotibial joint as evaluated by MRI at 2 years
time frame: Baseline and 2 years

Secondary Outcomes

Measure
Changes from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and in the WOMAC pain, function, and stiffness index scores up to 2 years
time frame: Up to 2 years
Change from Baseline in the 20-meter walk test up to 2 years
time frame: Up to 2 years
Change from Baseline in the Patient's Global Assessment (PGA) up to 2 years
time frame: Up to 2 years
Change from Baseline in minimal joint space width (JSW) in the medial and lateral compartments as evaluated by X-ray up to 2 years
time frame: Up to 2 years
Change from Baseline in cartilage thickness in the medial and lateral compartments as well as in the total femorotibial joint up to 2 years
time frame: Up to 2 years
Change from Baseline in cartilage volume in the medial and lateral compartments as well as in the total femorotibial joint up to 2 years
time frame: Up to 2 years
Synovial fluid levels of AS902330
time frame: Up to 2 years
Serum levels of AS902330
time frame: Up to 2 years
Number of Subjects with Adverse Events
time frame: Up to Week 260

Eligibility Criteria

Male or female participants from 40 years up to 85 years old.

Inclusion Criteria: - Age from 40 to 85 years; of either sex - Primary femorotibial osteoarthritis according to American College of Rheumatology (ACR) clinical and radiographic criteria , and meeting protocol-specified X-ray criteria in the target knee at screening - Pain score in the target knee and/or the need for regular symptomatic treatment of knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory drugs (NSAIDs) including cyclooxygenase (COX)-2 selective inhibitors (coxibs), or tramadol on most days in the previous month (that is, more than half of the days in the previous month) - A history of pain due to Osteoarthritis in the target knee for at least 6 months - A protocol-specified pain score for the target knee in response to Question 1 of the WOMAC pain index ("how much pain have you had [in the target knee, over the past 48 hours] when walking on a flat surface?") after washout of at least 5 half-lives of analgesic medication(s): acetaminophen, topical or oral NSAIDS, coxibs, opioids, and/or tramadol - Women of childbearing potential must use a form of contraception with a failure rate of less than 1 percent per year throughout the trial Exclusion Criteria: - Malalignment of greater than 5 degrees in the femorotibial axis of the target knee - Clinical signs of inflammation (redness) in the target knee - Intra-articular administration of corticosteroids or hyaluronic acid into either knee within 6 months before Screening - Planned knee surgery (affecting either the target or the contralateral knee) within the next two years - Concomitant conditions or treatments deemed to be incompatible with trial participation - Any contraindication to MRI according to MRI guidelines, including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil - Pregnancy or breastfeeding - Participation in another clinical trial within the 30 days (or 5 half-lives of the investigated compound, whichever is longer) before screening - Legal incapacity or limited legal capacity

Additional Information

Official title A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Different Intra Articular (i.a.) Dosages of Sprifermin in Subjects With Primary Osteoarthritis of the Knee
Description Subjects will be equally randomized to either one of 4 treatment arms or a placebo arm. The trial consists of a Screening period lasting up to 42 days, a two-year double-blind placebo-controlled (DBPC) treatment phase, which begins at randomization (Week 0) and ends at Year 2, and a 3-year extended follow-up phase.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by EMD Serono.