A Phase 2 interventional study of ALLN-346 and Placebo in Hyperuricemia, Gout and Chronic Kidney Diseases, sponsored by Allena Pharmaceuticals. Terminated at 17 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-23.
Sponsored by Allena Pharmaceuticals · Phase 2, Interventional, and Treatment
Among 75 studies in Hyperuricemia with a site in United States — 6 open to participants now, 10 under way, 3 of them phase 3. Hyperuricemia · United States.
Among the 75 studies in Hyperuricemia with a site in United States, this one is the 63rd largest by enrollment of the 70 interventional ones, is one of 4 that started in 2022, is one of 33 in phase 2, and was the 57th registered.
240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.
This study's enrollment of 19 is below the median of 68 across 193 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →6 of the 75 studies in Hyperuricemia with a site in United States are open now, in 7 countries. Each count lists the studies.
Of the 29 Hyperuricemia studies recruiting now, 8 (28%) set no upper age limit and 13 (45%) stop at 75 or younger; 1 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →75 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2022.
Median enrollment 39 across the 70 interventional studies, 100 across the 5 observational. Of the 60 that completed or were terminated, 21 (35%) have results posted.
56 of 75 have an industry lead sponsor. The 10 most frequent:
Allena Pharmaceuticals is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Allena Pharmaceuticals has 5 studies filed under Hyperuricemia — fewer than ten, so there is no comparison to draw.
5 of the studies in Hyperuricemia with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05658575Phase 3Olatec Therapeutics, Inc.Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare | 2026-12-31 |
| NCT07089875Phase 3Crystalys TherapeuticsA Study of Dotinurad Versus Allopurinol in Participants With Gout | 2027-11-29 |
| NCT07116746Arthrosi TherapeuticsEvaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients | 2026-11 |
| NCT04752293Wake Forest University Health SciencesPediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE) | 2026-12 |
| NCT06859073Novo Nordisk A/SA Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia | 2027-01-19 |
Among the 75 studies in Hyperuricemia with a site in United States, from their registry updates:
The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.
This is a randomized, double-blind, placebo-controlled parallel group, multi-center phase II clinical study or orally administered ALLN-346 in subjects with hyperuricemia, gout and mild to moderate chronic kidney disease over a two-week period. Subjects will be enrolled in two cohorts based on estimated glomerular filtration rate (eGFR).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: ALLN-346
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.
Drug: Placebo
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
Also known as: Engineered urate oxidase
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Also known as: Matching placebo capsule
Incidence of Treatment Emergent Adverse Events (TEAEs)
Treatment emergent adverse events
Time frame: 42 days
Serum Urate
Serum urate \[mg/dL\]
Time frame: 14 Days
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2022 to primary completion in Sep 2022, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ALLN-346
Allena Pharmaceuticals