A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Assessing the Efficacy, Safety, and Dosing Regimen Selection of Multiple Intravenous Infusions of PRX-115 With and Without Methotrexate Versus Placebo in Adult Patients With Gout (RELEASE)
Protalix
Summary
This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the respective placebos in adult patients with gout.
Description
This study will evaluate the efficacy, safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of PRX-115 (a recombinant pegylated Uricase) in adult patients with gout. Participants will receive PRX-115 by intravenous (IV) infusions according to different treatment schedules, with and without the immunomodulator methotrexate (MTX).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Males or females ≥18 years of age. 2. Weight within the range of 50.0 - 150.0 kg. 3. Gout patients who failed to normalize sUA (\<7 mg/dL) with or without xanthine oxidase inhibitors or uricosuric agent or have contraindications to these drugs. 4. Willing to discontinue any oral ULT 5. Females who are sterile, postmenopausal, or non-pregnant and using birth control methods. Exclusion Criteria: 1. Any condition known to have arthritis as a clinical manifestation. 2. Positive testing for HBV,HCV, or HIV. 3. The patient is a pregnant or lactating female or plans to becom…
Interventions
- BiologicalPRX-115
intravenous (IV) infusion
- DrugMethotrexate (MTX)
Oral MTX 15 mg weekly
- OtherPRX-115 placebo
intravenous (IV) infusion
- OtherPlacebo-Methotrexate
Oral Placebo-MTX weekly
Location
- Bioclinical Research Alliance, IncMiami, Florida