HyperuricemiaPhase 2NCT04987242
An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)
A Phase 2 study testing ALLN-346 in people with Hyperuricemia and Gout, run by Allena Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia in an inpatient, controlled setting. Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2021to 2 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 55 years
- sUA level ≥ 6.8 mg/dL at Screening (hyperuricemia), with or without a diagnosis of gout
- 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
- Normal non-clinically significant abnormalities in vital signs
- Normal clinical laboratory test results and ECG, which are not considered to be clinically significant
Who cannot join
- Screening eGFR of <60 mL/minute/1.73 m2 for Part 1, and for Part 2 Screening eGFR outside the range of 45-100 mL/minute/1.73 m2.
- History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, urological, or psychiatric disorders.
- Presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
- Currently taking any urate-lowering medication within 4 weeks prior to Day 1 (first dosing day)
- Prior uricase therapy or exposure to recombinant uricase
- Clinically significant abnormal findings on electrocardiogram (ECG)
Show all 10Show fewer
- Positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody
- 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
1 site in 1 country.
About this study
Official title: An Inpatient, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects
The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia in an inpatient, controlled setting.
Read the detailed description
This is a Phase II, 7-day, randomized, double-blind, placebo-controlled study of orally administered ALLN-346 in subjects with hyperuricemia, with subpopulations to include generally healthy hyperuricemic subjects with normal kidney function and those with mild to moderate chronic kidney disease (CKD). Study will take place at a clinical pharmacology unit (CPU). The study will have two Parts. Part 1 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR ≥ 60 mL/minute/1.73 m2 (subjects with eGFR of stage 2 CKD and with normal kidney function). Part 2 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR 45-100 mL/minute/1.73 m2 (eGFR of CKD Stages 2- 3a).
The study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and pharmacodynamics of ALLN-346.
- 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: 5 capsules thrice daily (TID) for a total of 15 capsules per day will be evaluated for 7 days Receives: Drug: ALLN-346 |
| Placebo | Placebo comparator | Matching placebo capsules for oral administration: 5 capsules thrice daily (TID) for a total of 15 capsules per day will be evaluated for 7 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)
Number of of participants with treatment emergent adverse events
Measured: 21 days per Study Part
Secondary outcomes (1)
Serum ALLN-346
Serum concentration of ALLN-346 (ng/mL)
Measured: 8 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 start16 Jul 2021
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
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
- Study population includes generally healthy subjects with hyperuricemia without CKD, and those with eGFR of mild-moderate CKD. The maximal tolerated dose from the MAD study in normal healthy volunteers (Study 102) will be administered. The study is comprised of two Parts. Under optional Part 2, only subjects with eGFR of CKD Stages 2- 3a.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 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 Pharmceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987242
- Sponsor's protocol ID
- ALLN-346-201
- Status last verified
- Jun 2023
- First submitted
- 26 Jul 2021
- Last updated
- 22 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 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Inpatient, Placebo-Controlled Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects
- ClinicalTrials.gov ID
- NCT04987242
- Acronym / sponsor ID
- ALLN-346-201
- Conditions
- Hyperuricemia, Gout, Chronic Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Allena PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 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 and tolerability of ALLN-346 in subjects with hyperuricemia in an inpatient, controlled setting.
Detailed description
This is a Phase II, 7-day, randomized, double-blind, placebo-controlled study of orally administered ALLN-346 in subjects with hyperuricemia, with subpopulations to include generally healthy hyperuricemic subjects with normal kidney function and those with mild to moderate chronic kidney disease (CKD). Study will take place at a clinical pharmacology unit (CPU). The study will have two Parts. Part 1 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR ≥ 60 mL/minute/1.73 m2 (subjects with eGFR of stage 2 CKD and with normal kidney function). Part 2 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR 45-100 mL/minute/1.73 m2 (eGFR of CKD Stages 2- 3a).
The study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and pharmacodynamics of ALLN-346.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Study population includes generally healthy subjects with hyperuricemia without CKD, and those with eGFR of mild-moderate CKD. The maximal tolerated dose from the MAD study in normal healthy volunteers (Study 102) will be administered. The study is comprised of two Parts. Under optional Part 2, only subjects with eGFR of CKD Stages 2- 3a.
| Arm | Type | Receives |
|---|---|---|
| ALLN-346 (Engineered Urate Oxidase) | Experimental | Drug: ALLN-346ALLN-346 is novel urate oxidase provided as capsules for oral administration: 5 capsules thrice daily (TID) for a total of 15 capsules per day will be evaluated for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsules for oral administration: 5 capsules thrice daily (TID) for a total of 15 capsules per day will be evaluated for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age 18 to 55 years
- sUA level ≥ 6.8 mg/dL at Screening (hyperuricemia), with or without a diagnosis of gout
- 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
- Normal non-clinically significant abnormalities in vital signs
- Normal clinical laboratory test results and ECG, which are not considered to be clinically significant
Key exclusion criteria (10 listed)
- Screening eGFR of <60 mL/minute/1.73 m2 for Part 1, and for Part 2 Screening eGFR outside the range of 45-100 mL/minute/1.73 m2.
- History or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, urological, or psychiatric disorders.
- Presence or history of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines
- Currently taking any urate-lowering medication within 4 weeks prior to Day 1 (first dosing day)
- Prior uricase therapy or exposure to recombinant uricase
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: 21 days per Study Part
Number of of participants with treatment emergent adverse events
1 secondary outcome
Serum ALLN-346
Time frame: 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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 Pharmceuticals
1 site 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 1 site 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 22 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 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 21 days per Study Part). 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 22 Jun 2023.