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A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)

ConditionGout
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorProtalix

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males or females ≥18 years of age.

Weight within the range of 50.0 - 150.0 kg.

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.

Willing to discontinue any oral ULT

Disqualifiers

Any condition known to have arthritis as a clinical manifestation.

Positive testing for HBV,HCV, or HIV.

The patient is a pregnant or lactating female or plans to become pregnant during the study period.

Known allergy or sensitivity to the injected proteins, including pegylated products.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PRX-115

    Biological/Vaccine

    intravenous (IV) infusion

  • Methotrexate (MTX)

    Drug

    Oral MTX 15 mg weekly

  • PRX-115 placebo

    Other intervention

    intravenous (IV) infusion

  • Placebo-Methotrexate

    Other intervention

    Oral Placebo-MTX weekly

Treatment groups

150 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: E4W with placebo-MTXExperimental treatment 2 interventions
Group B: E4W with MTXExperimental treatment 2 interventions
Group C: E6W with MTXExperimental treatment 2 interventions
Group D: E8W with MTXExperimental treatment 2 interventions
Group E: placebo E4WPlacebo comparator 2 interventions
Group F: placebo E6WPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) During Month 6

Proportion of patients who achieve a reduction in sUA to \<6.0 mg/dL for at least 80% of the time during Month 6

Time frame
6 months of treatment

Secondary outcomes

1

Percentage of Serum Uric Acid (sUA) Responders (sUA < 6 mg/dL) at different time points

Proportion of patients that achieve a reduction in sUA to \<6.0 mg/dL for at least 80% of the time during Month 3 or 4, 5 and 6.

Time frame
3 to 6 months of treatment
2

Treatment-emergent adverse events (TEAEs)

Occurrence and severity of treatment-emergent adverse events (TEAEs)

Time frame
From enrollment to 8 months of study

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Protalix

Lead sponsor

Source ClinicalTrials.gov
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