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Enzyme

ALLN-346 for Gout

Phase 2
Waitlist Available
Research Sponsored by Allena Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights

Study Summary

This study is evaluating whether a drug called ALLN-346 can help lower uric acid levels in people with gout and kidney disease.

Eligible Conditions
  • Gout
  • High Uric Acid
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment Emergent Adverse Events (TEAEs)
Secondary outcome measures
Serum Urate

Side effects data

From 2007 Phase 3 trial • 280 Patients • NCT00230178
58%
Nausea
57%
Diarrhoea
55%
Thrombocytopenia
53%
Neutropenia
50%
Oedema peripheral
48%
Pyrexia
38%
Hypokalaemia
38%
Vomiting
34%
Hypocalcaemia
34%
Anaemia
29%
Hyperglycaemia
29%
Hypotension
28%
Chills
28%
Rash
27%
Hypoalbuminaemia
27%
Constipation
27%
Hyponatraemia
27%
Headache
25%
Mucosal inflammation
24%
Anxiety
22%
Tachycardia
22%
Anorexia
22%
Dyspnoea
21%
Febrile neutropenia
21%
Fatigue
20%
Abdominal pain
18%
Insomnia
18%
Cough
17%
Petechiae
17%
Hypophosphataemia
17%
Epistaxis
16%
Leukopenia
16%
Aspartate aminotransferase increased
16%
Confusional state
15%
Blood bilirubin increased
15%
Hyperbilirubinaemia
15%
Dizziness
15%
Hypomagnesaemia
14%
Pharyngolaryngeal pain
13%
Back pain
13%
Asthenia
13%
Depression
12%
Hypertension
12%
Haematuria
12%
Fluid overload
11%
Reproductive system and breast disorders
11%
Abdominal pain upper
11%
Arthralgia
11%
Pleural effusion
11%
Sepsis
11%
Alanine aminotransferase increased
11%
Hypoxia
11%
Pruritus
10%
Dyspepsia
10%
Catheter site pain
10%
Pneumonia
10%
Bacteraemia
10%
Wheezing
10%
Hyperphosphataemia
9%
Haemorrhoids
9%
Musculoskeletal chest pain
9%
Abdominal distension
9%
Pain
9%
Agitation
9%
Lethargy
9%
Dysuria
9%
Alopecia
8%
Blood creatinine increased
8%
Pain in extremity
8%
Rales
8%
Hyperkalaemia
8%
Erythema
8%
Hyperhidrosis
7%
Atrial fibrillation
7%
Flatulence
7%
Oedema
7%
Cellulitis
7%
Contusion
7%
Blood alkaline phophatase increased
7%
Dysgeusia
7%
Proteinuria
7%
Pleuritic pain
5%
Catheter site erythema
5%
Hypernatraemia
5%
Catheter site related reaction
5%
Procedural pain
5%
Angina pectoris
5%
Oral candidiasis
5%
Somnolence
5%
Pulmonary oedema
5%
Neutropenic infection
5%
Neutropenic sepsis
5%
Decreased appetite
5%
Ecchymosis
4%
Catheter site haemorrhage
4%
Oral pain
4%
Transfusion reaction
4%
Blood pressure increased
4%
Proctalgia
4%
Platelet count decreased
4%
Rash generalised
3%
Rectal haemorrhage
3%
Musculoskeletal pain
3%
Stomatitis
3%
Dysphagia
3%
Malaise
3%
Hallucination
3%
Hiccups
2%
Hyperphosphatasaemia
2%
Myalgia
2%
Respiratory failure
2%
Respiratory distress
2%
Haemoglobin decreased
2%
Paraesthesia
2%
Abdominal discomfort
2%
Dry mouth
2%
Multi-organ failure
2%
Blood lactate dehydrogenase decreased
2%
Weight decreased
2%
Syncope
2%
Dyspnoea exertional
1%
Hypersensitivity
1%
Hypoglycaemia
1%
Reversible posterior leukoencephalopathy syndrom
1%
Neurotoxicity
1%
Pancytopenia
1%
Cardio-respiratory arrest
1%
Cholelithiasis
1%
Acute myeloid leukaemia
1%
Pulmonary haemorrhage
1%
Acute respiratory distress syndrome
1%
Pulmonary edema
1%
Lymphopenia
1%
Bradycardia
1%
White blood cell count decreased
1%
Tumor lysis syndrom
1%
Small intestinal obstruction
1%
Septic shock
1%
Systemic mycosis
1%
Peripheral motor neuropathy
1%
Pulmonary embolism
1%
Ear and labyrinth disorder
1%
Blood alkaline phosphatase decreased
1%
Neck pain
1%
Acute myocardial infarction
1%
Pericardial effusion
1%
Renal failure
1%
Rhinorrhoea
1%
Myocardial infarction
1%
Adverse drug reaction
1%
Drug toxicity
1%
Renal failure acute
1%
Blood phosphorus increased
1%
Infection
1%
Lung infection
1%
Subdural haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rasburicase
Rasburicase + Allopurinol
Allopurinol

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ALLN-346 (Engineered Urate Oxidase)Experimental Treatment1 Intervention
ALLN-346 is novel urate oxidase provided as capsules for oral administration. ALLN-346 will be administered as 5 capsules thrice daily (15 capsules per day total) to each of two subject cohorts based on estimated glomerular filtration rate (eGFR). Treatment Period is 14 Days.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo capsules for oral administration. Placebo capsules will be administered as 5 capsules thrice daily (15 capsules per day total) to each of two subject cohorts based on estimated glomerular filtration rate (eGFR). Treatment Period is 14 Days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALLN-346
2021
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Allena PharmaceuticalsLead Sponsor
11 Previous Clinical Trials
428 Total Patients Enrolled
3 Trials studying Gout
46 Patients Enrolled for Gout
C Tosone, MS, RACStudy DirectorAllena Pharmaceuticals
1 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Gout
16 Patients Enrolled for Gout

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
2022. "Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04987294.
~7 spots leftby Apr 2025
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