Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05099640 · ClinicalTrials.gov registry record · Phase 3
A Study of PTC923 in Participants With Phenylketonuria
A Phase 3 study, sponsored by PTC Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 157
- Enrollment target
NCT05099640: Completed Phase 3 study, sponsored by PTC Therapeutics.
NCT05099640 is a Phase 3 study that has completed, run by PTC Therapeutics. The registered enrollment target is 157 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05099640, a Phase 3 study, has completed, sponsored by PTC Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 157 participants
- Enrollment target
Study Summary
The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).
Primary Outcome
Baseline was defined as the average of Day -1 and Day 1 predose blood Phe levels in Part 2, and mean level at Weeks 5 and 6 was calculated as the average of blood Phe levels collected during the Week 5-6 analysis visit window. Least square (LS) mean and standard error (SE) were calculated using mixed model repeated measures (MMRM) method.
Interventions
- DRUG Placebo
- DRUG PTC923
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2021-09-30 |
| Est. Completion | 2023-05-03 |
| Phase | Phase 3 |
What the finished NCT05099640 record still lists
NCT05099640 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05099640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05099640 about?
NCT05099640 is a clinical study titled "A Study of PTC923 in Participants With Phenylketonuria". The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period o...
What is the current status of trial NCT05099640?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 157 participants. The study started on 2021-09-30. Estimated completion is 2023-05-03.
What interventions are being tested in trial NCT05099640?
The interventions under investigation include: Placebo (DRUG), PTC923 (DRUG).
Who is sponsoring clinical trial NCT05099640?
This trial is sponsored by PTC Therapeutics, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05099640's enrollment target sits among peer trials
157 1505th of 2000 higher than 495 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05052541 · 157 participants · Phase 3
Safety and Efficacy of Oral Cannabis in Chronic Spine Pain
- NCT05076942 · 157 participants · Phase 2
Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
- NCT06396598 · 157 participants · NA
Electronic Symptom Monitoring Program for Triggered Palliative Referrals in Patients With Thoracic Cancer
- NCT06655246 · 157 participants · Phase 1
A Study of Ziftomenib in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI