UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder (NCT03933410) | Clinical Trial Compass
TerminatedPhase 2
UNLOCKED: A Phase 2, Open-label Trial With KB195 in Subjects With a Urea Cycle Disorder
Stopped: Kaleido Biosciences, Inc. closed the K020-218 trial due to business reasons, and not due to any safety concerns.
United States13 participantsStarted 2019-09-17
Plain-language summary
UNLOCKED: A Phase 2 Trial to Evaluate the Efficacy and Safety of KB195 in Subjects with a Urea Cycle Disorder with Inadequate Control on Standard of Care
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
* Signed informed consent and willing to comply with protocol-specified procedures.
* Has any confirmed UCD other than N-acetyl glutamatesynthase (NAGS) deficiency.
* Is male or female, 12 to 70 years of age (inclusive)
* If ≥ 18 years old, has a BMI ≥20.0 and \< 40.0 kg/m2. If \< 18 years old, has a BMI between 5th percentile and 95th percentile and weight greater than 5th percentile according to age, sex and regionally appropriate growth chart
* Has evidence of poorly controlled disease on the current standard of care (SOC)
* If NBT is part of SOC, is on a stable dose and regimen for at least 4 weeks before Screening and the dose is expected to remain stable during the study
* Is willing to maintain a stable diet throughout the course of study and is willing to continue usual exercise routine.
* If taking probiotics or prebiotics, is on a stable dose regimen for at least 4 weeks before Screening and the dose and regimen are expected to remain stable during the study
* Has a negative urine screen for drugs of abuse at Screening
* If male or female of child bearing potential, agree with use effective method of contraception for the duration of the study and 90 days after last dose of study product
Key Exclusion Criteria:
* Is at a high risk for metabolic decomposition.
* Has had a substantive change in diet or any other aspect of UCD management within 4 weeks before the Screening Visit
* Has used a systemic anti-infective within 4 weeks before the S…
What they're measuring
1
Proportion of subjects who achieve a ≥15% reduction from baseline in fasting plasma ammonia at the end of treatment.