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Monoclonal Antibodies

Burosumab for Fibrous Dysplasia

Phase 2

Waitlist Available

Led By Alison M Boyce, M.D.

Research Sponsored by National Institute of Dental and Craniofacial Research (NIDCR)

Eligibility Criteria Checklist

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

Must have

Confirmed diagnosis of fibrous dysplasia

- Male sterilization (at least 6 months prior to screening). For female participants on the study the vasectomized male partner should be the sole partner for that participant

Must not have

Severe renal impairment or end stage renal disease, defined as: pediatric patients with estimated glomerular filtration rate (eGFR) 15 mL/min/1.73m2 to 29 mL/min/1.73m2 or end stage renal disease (eGFR < 15 mL/min/1.73m2), adult patients with creatinine clearance (CLcr) 15 mL/min to 29 mL/min or end stage renal disease (CLcr < 15 mL/min)

Treatment with burosumab within 30 days of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks (adults), 50 weeks (children)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a study drug (burosumab) to see if it helps people with FD who have low blood phosphate levels. People with FD are prone to deformities, fractures, and other problems. The study will last 48 weeks, and participants will visit the NIH 3 times. They will self-inject the drug at home 1-2 times/month.

Who is the study for?

This trial is for people of any age over 1 year with fibrous dysplasia (FD) and low blood phosphate levels. Participants must be able to self-inject the study drug, burosumab, agree to use effective contraception if of reproductive potential, and have a minimum body weight of 7.5 kg. Those who are pregnant or lactating, have severe kidney issues, or have used burosumab or other investigational drugs recently cannot join.

What is being tested?

The trial tests burosumab in individuals with FD who suffer from weak bones due to low phosphate levels. Over 48 weeks, participants will visit NIH three times for extensive testing including physical exams and bone scans while self-administering injections at home regularly under telehealth guidance.

What are the potential side effects?

Potential side effects of burosumab may include reactions at the injection site such as redness or pain, headache, tiredness, dizziness and possibly allergic reactions in those sensitive to the drug's components.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with fibrous dysplasia.

Select...

I am a male sterilized at least 6 months ago, or my only partner is a vasectomized male.

Select...

I use a highly effective hormonal birth control method.

Select...

I weigh at least 7.5 kilograms.

Select...

My blood phosphate levels are very low and my FGF23 hormone level is high.

Select...

I am at least 1 year old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe kidney problems or am in the final stage of kidney disease.

Select...

I have not taken burosumab in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks (adults), 50 weeks (children)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks (adults), 50 weeks (children)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks (adults), 50 weeks (children) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of subjects achieving serum phosphate levels within the target range (Z-score -1 to +2) at Week 48

Secondary study objectives

Adverse events and clinical safety laboratory tests for up to 4 weeks after the final burosumab dose

Change and percent change from baseline to post-baseline visits in serum phosphate, serum 1,25(OH)2D, ratio of renal tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR).

Change and percent change in serum bone turnover markers, including procollagen 1 N-terminal propeptide (P1NP), beta crosslaps C-telopeptides (CTX), osteocalcin, and bone-specific alkaline phosphatase from baseline to 48 weeks.

+6 more

Side effects data

From 2021 Phase 2 trial • 17 Patients • NCT02304367

64%

Pain In Extremity

64%

Arthralgia

50%

Upper Respiratory Tract Infection

50%

Cough

43%

Diarrhoea

36%

Nausea

36%

Vomiting

36%

Nasopharyngitis

36%

Back Pain

36%

Muscle Spasms

29%

Constipation

29%

Neoplasm Progression

29%

Urinary Tract Infection

29%

Musculoskeletal Pain

29%

Insomnia

29%

Hypertension

29%

Pain

29%

Fall

29%

Myalgia

29%

Amylase Increased

21%

Contusion

21%

Abdominal Pain

21%

Oedema Peripheral

21%

Influenza

21%

Ligament Sprain

21%

Procedural Pain

21%

Hypomagnesaemia

21%

Vitamin D Deficiency

21%

Joint Range Of Motion Decreased

21%

Musculoskeletal Chest Pain

21%

Restless Legs Syndrome

21%

Nasal Congestion

21%

Oropharyngeal Pain

21%

Pulmonary Mass

21%

Rash

21%

Fatigue

21%

Respiratory Tract Congestion

21%

Bronchitis

14%

Cardiac Arrest

14%

Tinnitus

14%

Acute Respiratory Failure

14%

Anaemia

14%

Abdominal Pain Lower

14%

Toothache

14%

Asthenia

14%

Injection Site Reaction

14%

Pyrexia

14%

Foot Fracture

14%

Rib Fracture

14%

Tooth Fracture

14%

Creatinine Renal Clearance Decreased

14%

Lipase Increased

14%

Decreased Appetite

14%

Hyperglycaemia

14%

Hyperphosphataemia

14%

Hypocalcaemia

14%

Hypokalaemia

14%

Bone Lesion

14%

Bone Pain

14%

Anxiety

14%

Depression

14%

Nephrolithiasis

14%

Dyspnoea

14%

Upper Respiratory Tract Congestion

14%

Hypotension

14%

Chills

14%

Exostosis

14%

Neck Pain

14%

Dizziness

14%

Headache

14%

Acute Kidney Injury

14%

Abdominal Discomfort

14%

Abdominal Distension

14%

Joint Swelling

Concussion

Blood Creatinine Increased

Hyperuricaemia

Basal Cell Carcinoma

Melanocytic Naevus

Poor Quality Sleep

Bile Duct Stone

Hypoalbuminaemia

Hepatic Lesion

Abdominal Pain Upper

Ascites

Hepatic Cyst

Blood Creatine Increased

Seasonal Allergy

Dental Caries

Metastases To Pancreas

Renal Impairment

Echocardiogram Abnormal

Bradycardia

Retching

Pneumonia

Multi-Organ Failure

Pulseless Electrical Activity

Tooth Abscess

Cholangitis

Sialoadenitis

Eyelid Ptosis

Rheumatoid Arthritis

Metastases To Lung

Ovarian Cancer

Tumour Compression

Pickwickian Syndrome

Pulmonary Embolism

Coagulopathy

Leukocytosis

Tachycardia

Abdominal Mass

Dysphagia

Flatulence

Gastrooesophageal Reflux Disease

Hypoaesthesia Oral

Large Intestine Polyp

Localised Intraabdominal Fluid Collection

Poor Dental Condition

Stomatitis

Application Site Rash

Calcinosis

Chest Pain

Generalised Oedema

Injection Site Bruising

Injection Site Swelling

Medical Device Site Reaction

Nodule

Cystitis

Diverticulitis

H1n1 Influenza

Oesophageal Candidiasis

Oral Candidiasis

Sinusitis

Viral Upper Respiratory Tract Infection

Hip Fracture

Ligament Rupture

Tooth Injury

Blood Calcium Increased

Blood Cholesterol Increased

Blood Glucose Increased

Blood Parathyroid Hormone Increased

Blood Potassium Decreased

Blood Pressure Systolic Increased

Blood Sodium Decreased

Blood Uric Acid Increased

Computerised Tomogram Abdomen Abnormal

Electrocardiogram Abnormal

Electrocardiogram Qt Prolonged

Glycosylated Haemoglobin Increased

Liver Function Test Abnormal

Oxygen Saturation Decreased

Waist Circumference Increased

White Blood Cell Count Decreased

Gout

Hypercalcaemia

Hyponatraemia

Hypophosphataemia

Hypoproteinaemia

Metabolic Acidosis

Aneurysmal Bone Cyst

Bursitis

Flank Pain

Intervertebral Disc Annular Tear

Joint Stiffness

Muscle Mass

Osteosclerosis

Neuroma

Squamous Cell Carcinoma Of Skin

Thyroid Neoplasm

Cerebral Cyst

Clonus

Sensory Disturbance

Viith Nerve Paralysis

Agitation

Panic Attack

Sleep Talking

Haematuria

Hydronephrosis

Micturition Urgency

Nephrocalcinosis

Pollakiuria

Proteinuria

Renal Cyst

Urinary Incontinence

Prostatomegaly

Testicular Mass

Vaginal Haemorrhage

Haemothorax

Pulmonary Artery Dilatation

Actinic Keratosis

Decubitus Ulcer

Keloid Scar

Precancerous Skin Lesion

Pruritus

Rash Papular

Skin Irritation

Skin Lesion

Skin Mass

Skin Odour Abnormal

Deep Vein Thrombosis

Peripheral Venous Disease

Vasodilatation

Road Traffic Accident

Calculus Bladder

Pancreatic Carcinoma Metastatic

Pleural Effusion

Pancreatitis

Dyspepsia

Gait Disturbance

Peripheral Swelling

Gastrointestinal Infection

Gastrointestinal Viral Infection

Laceration

Post Procedural Haematoma

Scar

Skin Abrasion

Spinal Compression Fracture

Stress Fracture

Tibia Fracture

Ultrasound Kidney Abnormal

Hypercholesterolaemia

Soft Tissue Mass

Tendon Pain

Schwannoma

Squamous Cell Carcinoma

Dysgeusia

Hypoaesthesia

Sciatica

Vulva Cyst

Respiratory Acidosis

Septic Shock

Abdominal Hernia

Injection Site Pain

Conjunctivitis

Corona Virus Infection

Femur Fracture

Fibula Fracture

Radiation Mucositis

Musculoskeletal Stiffness

Migraine

Neuralgia

Paraesthesia

Chylothorax

Prostatic Specific Antigen Increased

100%

80%

60%

40%

20%

Study treatment Arm

KRN23 TIO

KRN23 XLH and ENS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Patients receiving treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Burosumab

2021

Completed Phase 3

~120

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Dental and Craniofacial Research (NIDCR)Lead Sponsor

305 Previous Clinical Trials

850,018 Total Patients Enrolled

1 Trials studying Fibrous Dysplasia

15 Patients Enrolled for Fibrous Dysplasia

Alison M Boyce, M.D.Principal InvestigatorNational Institute of Dental and Craniofacial Research (NIDCR)

3 Previous Clinical Trials

524 Total Patients Enrolled

1 Trials studying Fibrous Dysplasia

15 Patients Enrolled for Fibrous Dysplasia

Media Library

Burosumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05509595 — Phase 2

Fibrous Dysplasia Research Study Groups: Treatment

Fibrous Dysplasia Clinical Trial 2023: Burosumab Highlights & Side Effects. Trial Name: NCT05509595 — Phase 2

Burosumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509595 — Phase 2

~8 spots leftby Sep 2030

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Burosumab for Fibrous Dysplasia

Summary

Eligibility Criteria

Timeline

Treatment Details

Study Objectives

Side effects data

Awards & Highlights

Trial Design

Find a Location

Who is running the clinical trial?

Media Library

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