A Multicenter Trial of AS902330 (Recombinant Human Fibroblast Growth Factor-18) or Placebo After Microfracture Surgery for Cartilage Injury of the Knee



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:5/5/2014
Start Date:September 2012
End Date:December 2018
Contact:US Medical Information
Phone:888-275-7376

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase II Trial to Investigate the Efficacy and Safety of 30 Mcg and 100 Mcg AS902330 Given as One Cycle of Three Intra-articular Knee Injections Once a Week for Three Weeks as an Adjunct Treatment to Patients Following Microfracture Surgery for Cartilage Injury of the Knee.

This is a Phase 2, double-blind, multicenter, randomized, placebo-controlled trial to
evaluate the efficacy and safety of AS902330 (recombinant human fibroblast growth factor-18
[rhFGF-18]) as an adjunct treatment to subjects following microfracture (MFx) surgery for
cartilage injury of the knee.

Primary Objectives

- To evaluate the effect of AS902330 intra-articular knee injections as adjunct to MFx
surgery on the composition of the refilled cartilage in the target knee, as measured by
gadolinium-enhanced Magnetic Resonance Imaging (MRI) of cartilage (dGEMRIC) T1
relaxation time at 6 months after MFx surgery

- To evaluate the safety profile of AS902330 when administered intra-articular into the
knee as adjunct to MFx surgery in subjects with cartilage injury of the knee

Secondary Objectives

- To further support the efficacy and safety of AS902330 as an adjunct to MFx for
cartilage injury repair through symptomatic outcomes and quantitative MRI
measurement


Inclusion Criteria:

1. Subjects with candidature for MFx on the femoral articular surfaces (medial or
lateral condyles or trochlear groove), with intact subchondral bone

2. Subjects with moderate to severe pain in the target knee prior to surgery; average
score greater than equal to (>=) 4.0 over 7 consecutive days on Numeric Rating Scale
of Pain Intensity (completed within 30 [+15] days before surgery)

3. Intraoperative inclusion criteria: Subjects with 1 or 2 focal chondral lesions per
target knee, where peripheral debridement to healthy cartilage results in all of the
following:

- Each lesion has an area of >= 1 centimeter square (cm^2) and less than equal to
(<=) 4 cm^2

- Each lesion is <= 6 millimeter (mm) in depth, as measured from the surrounding
subchondral plate

- Arthroscopic confirmation that each non-osteochondritis dissecans (OCD) lesion
is between International Cartilage Repair Society (ICRS) Grades I and III (D); a
Grade III non-OCD lesion is equivalent to an Outerbridge Grade IV lesion with
minimal subchondral bone loss

Additional Inclusion Criteria apply

Exclusion Criteria:

1. Subjects with prior marrow stimulation treatment of the target knee, that is, MFx,
micro-drilling, abrasion chondroplasty or cartilage repair including, but not limited
to, autologous chondrocyte implantation (ACI), matrix/membrane autologous chondrocyte
implantation (MACI), or osteochondral transplantation (autologous or allogeneic)

2. Subjects with Body Mass Index (BMI) of greater than 35 kilogram per meter square
(kg/m^2) at screening

3. Malalignment of the target knee greater than 5 degrees as measured from the
mechanical axis, as confirmed by alignment (long bone) X-ray images

4. Subjects with clinical and/or radiographic disease diagnosis of the target knee joint
including, but not limited to, the following: generalized osteoarthritis (OA),
rheumatoid arthritis, or avascular necrosis

5. Subjects who have any contraindication to MRI or gadolinium-based or iodinated
contrast agents according to the site's standard practice guidelines

Additional Exclusion Criteria apply
We found this trial at
1
site
Clinical Trial Facility in Boise Idaho
Boise, Idaho 83712
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from
Boise, ID
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