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NCT05116046 · ClinicalTrials.gov registry record · Phase 2
Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics and Efficacy of Recifercept in Achondroplasia
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT05116046 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 35 participants.
The verdict
NCT05116046, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
All participants who completed the prior study to assess long-term safety, tolerability, pharmacokinetics and efficacy, and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll in this open-label extension (OLE) study for up to an additional 24 months of treatment. Approximately 63 participants will be offered to continue at the previously received dose of Recifercept either Low Dose Medium Dose High Dose or at the therapeutic dose once it is identified. Participants will attend the clinic monthly for 24 months. Assessments include safety, blood sampling, physical examination, vital signs, anthropometric body measurements \& patient/caregiver quality of life questionnaires.
Interventions
- BIOLOGICAL Recifercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2021-12-24 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05116046
The ClinicalTrials.gov registry entry for NCT05116046 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Recifercept is the first listed.
NCT05116046 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05116046 about?
NCT05116046 is a clinical study titled "Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics and Efficacy of Recifercept in Achondroplasia". All participants who completed the prior study to assess long-term safety, tolerability, pharmacokinetics and efficacy, and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll in this open-label extension (OLE) study for up to an additional...
What is the current status of trial NCT05116046?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2021-12-24. Estimated completion is 2023-03-30.
What interventions are being tested in trial NCT05116046?
The interventions under investigation include: Recifercept (BIOLOGICAL).
Who is sponsoring clinical trial NCT05116046?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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