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Biological

Continuation Study of Long-term Safety, Tolerability, Pharmacokinetics and Efficacy of Recifercept in 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
No Placebo-Only Group

Summary

This trial involves patients who previously benefited from Recifercept. They will continue using the medication to test its long-term safety and effectiveness. The study will monitor their health and quality of life over an extended period.

Eligible Conditions
  • Achondroplasia

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Change From Baseline in Arm Span to Height/Length Difference at Months 3, 6, 9
Change From Baseline in Fixed Flexion Angles at Elbow at Months 3, 6, 9
Change From Baseline in Knee Height to Lower Segment Ratio at Months 3, 6, 9
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
4,669 Previous Clinical Trials
17,861,889 Total Patients Enrolled
4 Trials studying Achondroplasia
791 Patients Enrolled for Achondroplasia
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,891 Total Patients Enrolled
3 Trials studying Achondroplasia
623 Patients Enrolled for Achondroplasia
~9 spots leftby Dec 2025
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