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Enzyme

Shorter Infusion of Pegloticase + MTX for Gout

Phase 4

Waitlist Available

Research Sponsored by Horizon Therapeutics Ireland DAC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the maximum medically appropriate dose, or with intolerable side effects or a contraindication to xanthine oxidase inhibitor therapy based on medical record review or subject interview.

Presence of at least one tophus

Must not have

Severe chronic or recurrent bacterial infections, such as recurrent pneumonia or chronic bronchiectasis.

Current or chronic treatment with systemic immunosuppressive agents such as MTX, azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose of other corticosteroid on a chronic basis (defined as 3 months or longer) would also meet exclusion criteria.

Timeline

Screening 6 months

Treatment 6 months

Follow Up 2 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing if a gout medication is safe and works well when given with a shorter infusion time.

Who is the study for?

This trial is for adults over 18 with uncontrolled gout, defined by high uric acid levels and failure to respond to standard treatments. Participants must have had at least one gout-related lump (tophus) or two flares in the past year. They can't join if they've used certain immune-suppressing drugs, have severe kidney issues, G6PD deficiency, are pregnant or not using birth control, or have a recent history of cancer or heart problems.

What is being tested?

The study tests whether pegloticase given with methotrexate (MTX) can be safely administered over a shorter infusion time in patients with stubborn gout. It aims to see if this approach is tolerable and effective when traditional medications don't work.

What are the potential side effects?

Possible side effects include allergic reactions during infusion, such as rash or difficulty breathing; other potential risks may involve changes in blood pressure and sugar levels due to MTX.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My current gout medication isn't working or causes severe side effects.

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I have at least one gouty nodule.

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I have chronic gout.

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I have gout that hasn't improved with the highest safe dose of medication.

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I have gout that is not managed by my current treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I frequently get severe bacterial infections like pneumonia.

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I have been on long-term immunosuppressive drugs or steroids.

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I have severe kidney problems or am on dialysis.

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I haven't had recent serious heart issues or uncontrolled high blood pressure.

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I have not been treated with pegloticase, rasburicase, or any similar drugs.

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I am currently undergoing treatment for my cancer.

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I have not had cancer, except for non-dangerous skin cancer or early-stage cervical cancer, in the last 5 years.

Timeline

Screening ~ 6 months17 visits

Treatment ~ 6 months14 visits

Follow Up ~ 2 months2 visits

Screening ~ 6 months

Treatment ~ 6 months

Follow Up ~2 months

This trial's timeline: 6 months for screening, 6 months for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The incidence of participants experiencing Infusion Reactions (IRs), including anaphylaxis related to pegloticase

Secondary study objectives

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

The proportion of participants who experienced any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting Individual participant sUA Discontinuation Criteria.

Time to any of the following events: IR leading to discontinuation of treatment, anaphylaxis, or meeting individual participant sUA Discontinuation Criteria (two consecutive pre-infusion sUAs > 6mg/dL).

Side effects data

From 2015 Phase 3 trial • 139 Patients • NCT02001987

11%

Rheumatoid arthritis

11%

Rhinitis

Asthenia

Bronchitis

Nasopharyngitis

Alanine aminotransferase increased

Arthralgia

Headache

Neutropenia

Diarrhoea

Back pain

Hepatocellular injury

Transaminases increased

Insomnia

Abdominal pain

Urinary tract infection

Ear infection

Injection site erythema

Pruritus

Nausea

Hypertension

Gastric volvulus

Angioedema

Gastric ulcer

Intestinal ischaemia

Pulmonary embolism

Deep vein thrombosis

Hypertensive crisis

Iron deficiency anaemia

Cataract

Cervical dysplasia

Disseminated tuberculosis

Septic shock

Meningitis tuberculous

Fall

100%

80%

60%

40%

20%

Study treatment Arm

TCZ COMBO - All Participants

TCZ MONO - All Participants

TCZ - All Participants

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Pegloticase 60 Minute Infusion with methotrexate (MTX)Experimental Treatment1 Intervention

Pegloticase 60 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks

Group II: Pegloticase 45 Minute Infusion with methotrexate (MTX)Experimental Treatment1 Intervention

Pegloticase 45 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks

Group III: Pegloticase 30 Minute Infusion with methotrexate (MTX)Experimental Treatment1 Intervention

Pegloticase 30 Minute Infusion with methotrexate (MTX). Participants will receive MTX (15 mg) (weekly) during the Run-in Period, then pegloticase (every 2 weeks) with MTX (weekly) for 24 weeks

0 / 12Eligibility criteria met