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Biological

Recifercept for Achondroplasia

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, months 3, 6, 9
Awards & highlights

Study Summary

This trial is an extension of a previous study to assess the long-term safety and efficacy of Recifercept, a drug used to treat people with a positive risk:benefit profile. Approximately 63 participants will be offered the chance to continue taking the drug for up to 24 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, months 3, 6, 9
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 3, 6, 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Height at Month 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Severe AEs
Secondary outcome measures
Change From Baseline in Arm Span to Height/Length Difference at Months 3, 6, 9
Change From Baseline in Body Mass Index (BMI) at Months 3, 6, 9
Change From Baseline in Fixed Flexion Angles at Elbow at Months 3, 6, 9
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Medium DoseExperimental Treatment1 Intervention
Medium Dose
Group II: Low DoseExperimental Treatment1 Intervention
Low Dose
Group III: High DoseExperimental Treatment1 Intervention
High Dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Recifercept
2020
Completed Phase 1
~280

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,648 Total Patients Enrolled
4 Trials studying Achondroplasia
793 Patients Enrolled for Achondroplasia
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,089,085 Total Patients Enrolled
3 Trials studying Achondroplasia
625 Patients Enrolled for Achondroplasia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA approved of Recifercept for medicinal use?

"Our internal classification of recifercept's safety sits at 2 because, despite there being some information on its security profile, no studies have been conducted to prove the medication's efficacy."

Answered by AI

Does this medical trial cater to individuals aged 55 and over?

"To participate in this trial, individuals must be between 15 months and 12 years of age. Additionally, there are a total of 12 clinical trials for minors and 3 studies aimed at those 65 or above."

Answered by AI

What is the current enrollment count for this research study?

"That is correct. According to the clinicaltrials.gov page, this study which was initially posted on December 24th 2021 is currently enrolling participants from 6 different sites with a total goal of 63 patients."

Answered by AI

Are there any restrictions on who can partake in this medical investigation?

"To be eligible for this clinical trial, individuals must have achondroplasia and fall between the ages of 15 Months and 12 Years old. A total of 63 applicants will receive admission into the study."

Answered by AI

Are there ample sites in this city offering participation in the trial?

"There are 6 clinical trial centres currently recruiting participants for this study, including Nemours Children's Hospital in Wilmington, Long Beach Memorial Medical Center in Long Beach and Ocean Sleep Medicine in Irvine. Additionally, 3 other locations have been identified as potential sites."

Answered by AI

What is the overall objective of this investigation?

"This trial's chief efficacy measure, evaluated from baseline to 24 months following the last dose, is the Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs). Additionally, Pharmacokinetics - Apparent Clearance (CL/F), Change from Baseline in Polysomnography, and Change from Baseline in Lower Leg Length will be observed as secondary objectives. The former measurement assesses a drug's rate of metabolic elimination while the latter two respectively consider SaO2 nadir and knee height:lower segment ratio."

Answered by AI

Are there any openings for participants in this research?

"Data on clinicaltrials.gov reveals that this experiment is actively recruiting patients, having been posted in late December 2021 and most recently updated at the start of November 2022."

Answered by AI
~11 spots leftby Mar 2025