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Microbial Therapy
SYNB1934 for Phenylketonuria (SYNPHENY-3 Trial)
Phase 3
Waitlist Available
Research Sponsored by Synlogic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Diagnosis of PKU and failure to maintain recommended blood Phe levels on existing management (sapropterin, sepiapterin and/or Phe-restricted diet), demonstrated by uncontrolled blood Phe level ≥ 360 μmol/L on current therapy any time during screening and uncontrolled blood Phe level ≥ 360 μmol/L on current therapy when taking the average of the 3 most recent Phe levels from the participant's medical history (inclusive of any screening values). All screening values must be obtained more than 7 days apart, as determined by central or local laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 weeks
Awards & highlights
SYNPHENY-3 Trial Summary
This trial tests a new med. for up to 3 yrs. It has 3 phases: dose-escalating, double-blind placebo-controlled, and open-label extension.
Who is the study for?
Adults with Phenylketonuria (PKU) who haven't been able to control their blood Phe levels using current treatments can join. They should be on a stable diet and treatment for at least 1 month, agree to not change their diet or PKU management during the trial, and use contraception if applicable. Pregnant women, those on recent investigational drugs, antibiotics, or specific PKU therapies like Palynziq®, are excluded.Check my eligibility
What is being tested?
The study tests SYNB1934v1's effectiveness in managing PKU over three parts: initial dose finding up to 15 weeks; a double-blind phase where participants randomly get either SYNB1934v1 or placebo for four weeks; followed by an open-label extension lasting up to three years.See study design
What are the potential side effects?
Potential side effects of SYNB1934v1 aren't detailed here but may include reactions related to its ingredients such as E. coli Nissle or cinnamon. Participants with known allergies to these components are excluded from the trial.
SYNPHENY-3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have PKU and my blood Phe levels are too high despite current treatments.
SYNPHENY-3 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the percentage change in blood phenylalanine (Phe) level
To evaluate efficacy of SYNB1934v1 versus placebo in the responder population through the change from baseline to Week 4 in blood Phe level.
Secondary outcome measures
To assess proportion of participants with a ≥ 20% reduction in blood Phe level
To assess the absolute change in Phe level
To evaluate efficacy of SYNB1934v1 versus placebo in the responder population with regard to percent change from DEP baseline in blood Phe level at Week 4
+2 moreSYNPHENY-3 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RWP (Part 2)Experimental Treatment1 Intervention
Group II: RWP/Part 2Placebo Group1 Intervention
Find a Location
Who is running the clinical trial?
SynlogicLead Sponsor
9 Previous Clinical Trials
460 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using birth control during and for 2 weeks after the study.I am allergic to E. coli Nissle, SYNB1934v1 ingredients, or cinnamon and cannot tolerate certain acid-reducing medications.I can maintain my current diet and supplements throughout the study.I have received gene therapy for PKU.I have PKU and my blood Phe levels are too high despite current treatments.I have been on a stable dose of sapropterin or sepiapterin for 3 months.I have been taking Palynziq® for the last month.I am not pregnant and agree to regular pregnancy tests during the study.I have been diagnosed with or suspected to have DNAJC12 deficiency, biopterin synthesis deficiency, or irritable bowel syndrome.I am 18 years old or older.I am not planning to take any antibiotics, except for creams, before or during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: RWP (Part 2)
- Group 2: RWP/Part 2
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have joined the experiment thus far?
"Yes, records hosted on clinicaltrials.gov suggest that this medical trial is currently recruiting participants. First posted on March 14th 2023 and last amended two days later, the study requires 150 patients from one facility."
Answered by AI
Has the second part of RWP been granted approval from the FDA?
"We have assigned RWP (Part 2) a rating of 3, denoting a high degree of safety based on prior clinical research that attests to its efficacy and multiple trials verifying its security."
Answered by AI
Is enrollment for this research currently open?
"That is correct. According to clinicaltrials.gov, this research initiative has been actively seeking participants since March 14th of 2023 and the most recent update was posted on March 16th. 150 individuals are being sought out from a single medical centre for enrolment into the study."
Answered by AI
What goals are the researchers hoping to achieve with this medical experiment?
"The primary outcome for this study to be measured over 15 weeks is the alteration in blood phenylalanine levels from baseline at Week 4. Secondary objectives include assessing the proportion of patients with a ≥ 20% decrease in Phe, and evaluating the absolute change in their respective Phe levels during both the Randomized Withdrawal Period (RWP; Part 2) as well as Dose Escalating, Open-Label Period (DEP; Part 1)."
Answered by AI
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