GoutPhase 1NCT02464605
Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels
A Phase 1 study testing SEL-037 (pegsiticase) in people with Gout, run by Selecta Biosciences, Inc. at 2 sites in United States.
Trial summary
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Gout
- What is being tested?
- SEL-037 (pegsiticase)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to Jul 2016
- Phase
- Phase 1
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ages 21 to 75 inclusive. Female subjects must be of non-childbearing potential;
- Has at the Screening Visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;
- The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the Screening Visit
- Has adequate venous access and able to receive IV therapy;
- Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;
Who cannot join
- Prior exposure to any experimental or marketed uricase;
- History of any allergy to pegylated products,
- Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;
- History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
- Has participated in a clinical trial within 30 days of the Screening;
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Metroplex Clinical Research Center
Dallas, Texas, 75231
Altoona Center for Clincal Research
Duncansville, Pennsylvania, 16635
About this study
Official title: An Open-Label, Sequential, Ascending Single-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of an Intravenous Infusion of SEL-037 in Subjects With Elevated Blood Uric Acid Levels
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted.
Read the detailed description
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted. Cohorts of Subjects will be given a single, ascending dose intravenous infusion of SEL-037 and then monitored for safety, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days.
- Conditions
- Gout
- Being tested
- SEL-037 (pegsiticase)
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEL-037 (pegsiticase)Biological
Intravenous infusion of SEL-037
| Study group | Role | What they receive |
|---|---|---|
| SEL-037 (pegsiticase) | Experimental | Pegylated uricase Receives: Biological: SEL-037 (pegsiticase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
To assess the safety and tolerability of a single infusion of SEL-037 as assessed by frequency of drug related adverse events, graded by severity
Measured: 30 days
Secondary outcomes (3)
Pharmacokinetics of SEL-037 (AUC)
Measurement of the pharmacokinetics of SEL-037 over 30 days by area under the serum concentration versus time curve (AUC)
Measured: 30 days
Pharmacodynamics of SEL-037 (blood uric acid levels)
Pharmacodynamics of SEL-037 by measurement of blood uric acid levels over 30 days
Measured: 30 days
Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)
Immunogenicity of SEL-037 by measurement of anti-drug antibody levels over 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GoutStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selecta Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464605
- Sponsor's protocol ID
- SEL-037/101
- Status last verified
- Oct 2016
- First submitted
- 29 May 2015
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sands E, Kivitz A, DeHaan W, Leung SS, Johnston L, Kishimoto TK. Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia. Nat Commun. 2022 Jan 12;13(1):272. doi: 10.1038/s41467-021-27945-7.
PubMed 35022448
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Sequential, Ascending Single-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of an Intravenous Infusion of SEL-037 in Subjects With Elevated Blood Uric Acid Levels
- ClinicalTrials.gov ID
- NCT02464605
- Acronym / sponsor ID
- SEL-037/101
- Conditions
- Gout
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Selecta Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Jun 2015 (estimated)
- 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.
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted.
Detailed description
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted. Cohorts of Subjects will be given a single, ascending dose intravenous infusion of SEL-037 and then monitored for safety, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEL-037 (pegsiticase) | Experimental | Biological: SEL-037 (pegsiticase)Pegylated uricase |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects ages 21 to 75 inclusive. Female subjects must be of non-childbearing potential;
- Has at the Screening Visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;
- The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the Screening Visit
- Has adequate venous access and able to receive IV therapy;
- Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;
Key exclusion criteria (5 listed)
- Prior exposure to any experimental or marketed uricase;
- History of any allergy to pegylated products,
- Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;
- History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
- Has participated in a clinical trial within 30 days of the 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 |
|---|---|---|
| SEL-037 (pegsiticase)Intravenous infusion of SEL-037 | Biological | SEL-037 (pegsiticase) |
Primary outcome
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
Time frame: 30 days
To assess the safety and tolerability of a single infusion of SEL-037 as assessed by frequency of drug related adverse events, graded by severity
3 secondary outcomes
Pharmacokinetics of SEL-037 (AUC)
Time frame: 30 days
Pharmacodynamics of SEL-037 (blood uric acid levels)
Time frame: 30 days
Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)
Time frame: 30 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 21 Oct 2016.
- Derived from this study: PubMed 35022448Sands E, Kivitz A, DeHaan W, Leung SS, Johnston L, Kishimoto TK. Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia. Nat Commun. 2022 Jan 12;13(1):272. doi: 10.1038/s41467-021-27945-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SEL-037 (pegsiticase) in people with Gout, run by Selecta Biosciences, Inc. at 2 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 5 inclusion and 5 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02464605, which also lists 1 linked publication.
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 21 Oct 2016.