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Kinase Inhibitor

Infigratinib 0.25 mg/kg/day for Achondroplasia (PROPEL3 Trial)

Q: Are there still openings in this research program?

Per the information on clinicaltrials.gov, this particular trial has closed its recruitment program - starting from November 10th 2023 and finishing last December 11th 2023. Fortunately, there are 14 other trials recruiting participants at present.

Q: How many venues is the experiment being conducted in?

Currently, the trial is recruiting patients from 29 different sites. In addition to Bergen, Nashville and Vitoria-Gasteiz, there are 26 other locations that may be more convenient for you based on your location.

Q: Has the FDA granted authorization for Infigratinib to be administered in a 0.25 mg/kg/day dosage?

According to our team at Power, infigratinib 0.25 mg/kg/day is assessed with a score of 3 on the safety scale due to previously collected evidence which supports both its effectiveness and security.

Q: Does the research include participants who are of legal age?

To be accepted in this medical trial, a patient must conform to the eligibility criteria which requires them to be 3-17 years old. A total of 14 studies are available for minors and an additional three exist for seniors aged 65+.

Q: Who qualifies to participate in this experiment?

110 participants will be accepted to this medical trial, provided they are between 3 and 17 years old and have achondroplasia.

Phase 3

Waitlist Available

Research Sponsored by QED Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must be 3 to <18 years of age at screening with growth potential defined as annualized height velocity of >1.5 cm/year over a period of at least 6 months, pubertal Tanner stage ≤4, and bone age ≤13 years in females and ≤15 years in males.

Subjects are ambulatory and able to stand without assistance. Sex and Contraceptive/Barrier Requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

PROPEL3 Trial Summary

This trial tests a drug to help children and teens with achondroplasia. It's randomized, double-blind, and placebo-controlled.

Who is the study for?

This trial is for children and adolescents aged 3 to <18 with achondroplasia, who are still growing and have completed at least 26 weeks in the PROPEL study. They must be able to swallow pills, stand without help, not be fully sexually mature, and girls of a certain age or menstruating must test negative for pregnancy.Check my eligibility

What is being tested?

The trial tests Infigratinib against a placebo in participants with achondroplasia. It's a Phase 3 study where patients are randomly assigned to receive either the drug or an inactive substance (placebo), but neither they nor the doctors know which one they're getting.See study design

What are the potential side effects?

Possible side effects of Infigratinib may include joint pain, gastrointestinal issues like nausea or diarrhea, liver problems indicated by blood tests changes, fatigue, and potential growth plate fusion affecting height.

PROPEL3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 3 and 18 years old, growing more than 1.5 cm a year, not fully through puberty, and meet the bone age requirement.

Select...

I can stand and walk without help.

Select...

I am not pregnant or have tested negative for pregnancy.

Select...

My ACH diagnosis is confirmed by clinical assessment and genetic testing.

PROPEL3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 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 (BL) in annualized height velocity (cm/year)

Secondary outcome measures

Absolute and change from baseline in arm span (cm) to standing height ratio

Absolute and change from baseline in head circumference (cm) to standing height ratio

Absolute and change from baseline in upper arm to forearm length ratio (cm)

+17 more

Side effects data

From 2023 Phase 2 trial • 158 Patients • NCT02159066

23%

Hypoalbuminaemia

23%

Oedema peripheral

23%

Anaemia

15%

Blood creatine increased

15%

Visual field defect

15%

Gamma-glutamyltransferase increased

15%

Urinary tract infection

15%

Nausea

15%

Diarrhoea

15%

Blood creatine phosphokinase increased

15%

Blood creatinine increased

Colitis

Pyrexia

Cancer pain

Femur fracture

Constipation

Rash maculo-papular

Intestinal perforation

Vomiting

Fatigue

Hypertension

Cardiac failure

Alanine aminotransferase increased

Gastrointestinal haemorrhage

Aphasia

Blood alkaline phosphatase increased

Pain in extremity

Cardiac arrest

100%

80%

60%

40%

20%

Study treatment Arm

Part II: Encorafenib + Binimetinib + Capmatinib

Part I: Encorafenib + Binimetinib (Naive)

Part I: Encorafenib + Binimetinib (Non-naive)

Part II: Encorafenib + Binimetinib + Ribociclib

Part II: Encorafenib + Binimetinib + Infigratinib

Part II: Encorafenib + Binimetinib + Buparlisib

PROPEL3 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Infigratinib 0.25 mg/kg/dayExperimental Treatment1 Intervention

Infigratinib at 2, 3.5, 5, 7, 10 mg

Group II: Placebo 0.25 mg/kg/dayPlacebo Group1 Intervention

Placebo Comparator at 2, 3.5, 5, 7, 10 mg

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

QED Therapeutics, Inc.Lead Sponsor

8 Previous Clinical Trials

872 Total Patients Enrolled

3 Trials studying Achondroplasia

638 Patients Enrolled for Achondroplasia

QED Therapeutics, Inc. Medical Director, Clinical DevelopmentStudy DirectorQED Therapeutics

Frequently Asked Questions

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

Are there still openings in this research program?

"Per the information on clinicaltrials.gov, this particular trial has closed its recruitment program - starting from November 10th 2023 and finishing last December 11th 2023. Fortunately, there are 14 other trials recruiting participants at present."

Answered by AI

How many venues is the experiment being conducted in?

"Currently, the trial is recruiting patients from 29 different sites. In addition to Bergen, Nashville and Vitoria-Gasteiz, there are 26 other locations that may be more convenient for you based on your location."

Answered by AI

Has the FDA granted authorization for Infigratinib to be administered in a 0.25 mg/kg/day dosage?

"According to our team at Power, infigratinib 0.25 mg/kg/day is assessed with a score of 3 on the safety scale due to previously collected evidence which supports both its effectiveness and security."

Answered by AI

Does the research include participants who are of legal age?

"To be accepted in this medical trial, a patient must conform to the eligibility criteria which requires them to be 3-17 years old. A total of 14 studies are available for minors and an additional three exist for seniors aged 65+."

Answered by AI