HyperuricemiaPhase 2NCT04987294
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
A Phase 2 study testing ALLN-346 in people with Hyperuricemia and Gout, run by Allena Pharmaceuticals at 17 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperuricemia, Gout, Chronic Kidney Diseases
- What is being tested?
- ALLN-346
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 17 sitesUnited States
- Study dates
- 2 Sep 2022to 2 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 70 years
- Serum UA level ≥ 8.0 mg/dL at Screening (hyperuricemia)
- Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout
- Screening eGFR of ≥60 - <90 mL/minute/1.73 m2 for Cohort A and ≥30 - <60 mL/minute/1.73 m2 for Cohort B.
- Concomitant medications stable for a minimum of 4 weeks prior to and during Screening
- Body Mass Index (BMI) ≥ 18 and ≤ 40 kg/m2, inclusive, at screening
- Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
Who cannot join
- Currently taking any oral urate-lowering medication within 2 weeks prior to Screening
- Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase
- Gout flare requiring treatment within 14 days prior to or during Screening
- Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening
- History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening
- Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening
- Prior dosing in ALLN-346 clinical study
- Per Investigator judgment, is not an ideal clinical study candidate
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Orthopedic Physicians Alaska
Anchorage, Alaska, 99508
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017
University of Alabama at Birmingham
Birmingham, Alabama, 35294
NY Total Medical Care, PC
Brooklyn, New York, 11215
Eastern Research, Inc.
Hialeah, Florida, 33013
Best Quality Research, Inc.
Hialeah, Florida, 33016
New Generation of Medical Research
Hialeah, Florida, 33016
Elite Clinical Research, LLC
Jackson, Mississippi, 39202
P&I Clinical Research, LLC
Lufkin, Texas, 75904
Kendall South Medical Center, Inc.
Miami, Florida, 33185
Allameh Medical Corporation
Mission Viejo, California, 92691
Burke Primary Care
Morganton, North Carolina, 28655
Syed Research Consultants, LLC
Muscle Shoals, Alabama, 35661
Briggs Clinical Research, LLC
San Antonio, Texas, 78224
Syed Research Consultants, LLC
Sheffield, Alabama, 35660
Summit research Group, LLC
Stow, Ohio, 44224
The Center of Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects With Gout and Mild to Moderate Chronic Kidney Disease
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.
Read the detailed description
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).
- Conditions
- Hyperuricemia, Gout, Chronic Kidney Diseases
- Being tested
- ALLN-346, Placebo
- Medical subject headings
- Hyperuricemia, Gout, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLN-346Drug
Also called Engineered urate oxidase
ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
PlaceboDrug
Also called Matching placebo capsule
Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
| Study group | Role | What they receive |
|---|---|---|
| ALLN-346 (Engineered Urate Oxidase) | Experimental | 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. Receives: Drug: ALLN-346 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Treatment emergent adverse events
Measured: 42 days
Secondary outcomes (1)
Serum Urate
Serum urate [mg/dL]
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start2 Sep 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Why it stopped: Company Financing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized 2:1 to receive ALLN-346 or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allena Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- C Tosone, MS, RAC, Study director, Allena Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987294
- Sponsor's protocol ID
- ALLN-346-202
- Status last verified
- Jun 2023
- First submitted
- 26 Jul 2021
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects With Gout and Mild to Moderate Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04987294
- Acronym / sponsor ID
- ALLN-346-202
- Conditions
- Hyperuricemia, Gout, Chronic Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Financing
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomized 2:1 to receive ALLN-346 or placebo.
| Arm | Type | Receives |
|---|---|---|
| ALLN-346 (Engineered Urate Oxidase) | Experimental | Drug: ALLN-346ALLN-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. |
| Placebo | Placebo comparator | Drug: PlaceboMatching 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, age 18 to 70 years
- Serum UA level ≥ 8.0 mg/dL at Screening (hyperuricemia)
- Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout
- Screening eGFR of ≥60 - <90 mL/minute/1.73 m2 for Cohort A and ≥30 - <60 mL/minute/1.73 m2 for Cohort B.
- Concomitant medications stable for a minimum of 4 weeks prior to and during Screening
Key exclusion criteria (8 listed)
- Currently taking any oral urate-lowering medication within 2 weeks prior to Screening
- Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase
- Gout flare requiring treatment within 14 days prior to or during Screening
- Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening
- History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALLN-346Also: Engineered urate oxidaseALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration | Drug | ALLN-346 (Engineered Urate Oxidase) |
| PlaceboAlso: Matching placebo capsuleMatched placebo capsules are similar in weight and appearance to the ALLN-346 capsules | Drug | Placebo |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: 42 days
Treatment emergent adverse events
1 secondary outcome
Serum Urate
Time frame: 14 Days
Results and safety
The study was stopped early (reason given: Company Financing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C Tosone, MS, RAC study director
Allena Pharmaceuticals
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALLN-346 in people with Hyperuricemia and Gout, run by Allena Pharmaceuticals at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company Financing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (TEAEs) (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2023.