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Corticosteroid
Pamrevlumab for Duchenne Muscular Dystrophy (LELANTOS-1 Trial)
Phase 3
Waitlist Available
Research Sponsored by FibroGen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 52
Awards & highlights
Pivotal Trial
Summary
This trial tests pamrevlumab with steroids in patients aged 12+ who have severe Duchenne muscular dystrophy and can't walk. The drug aims to reduce muscle damage by blocking a harmful protein.
Eligible Conditions
- Duchenne Muscular Dystrophy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 52
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 the Total Score of Performance of Upper Limb (PUL) 2.0 Version at Week 52
Secondary study objectives
Change From Baseline in Left Ventricular Ejection Fraction Percentage (LVEF %) at Week 52, Assessed by Magnetic Resonance Imaging (MRI)
Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) at Week 52, Assessed by Spirometry
Change From Baseline in Percent Predicted Peak Expiratory Flow (ppPEF) at Week 52, Assessed by Spirometry
+1 moreSide effects data
From 2017 Phase 2 trial • 160 Patients • NCT0189026530%
Respiratory tract infection
28%
Cough
26%
Dyspnoea
20%
Fatigue
20%
Idiopathic pulmonary fibrosis
20%
Urinary tract infection
18%
Nasopharyngitis
16%
Diarrhoea
16%
Sinusitis
14%
Nausea
10%
Arthralgia
10%
Back pain
8%
Pain
8%
Headache
8%
Upper-airway cough syndrome
8%
Abdominal pain upper
8%
Chest pain
8%
Oedema peripheral
8%
Dizziness
8%
Insomnia
6%
Sleep apnoea syndrome
6%
Myalgia
6%
Chest discomfort
6%
Heart sounds abnormal
6%
Decreased appetite
6%
Musculoskeletal pain
6%
Anxiety
6%
Pulmonary hypertension
6%
Sinus congestion
6%
Flushing
6%
Hypertension
4%
Bronchitis
4%
Constipation
4%
Interstitial lung disease
4%
Pulmonary embolism
4%
Contusion
2%
Musculoskeletal chest pain
2%
Autoimmune haemolytic anaemia
2%
Immune thrombocytopenic purpura
2%
Non-cardiac chest pain
2%
Acute respiratory failure
2%
Respiratory failure
2%
Angina pectoris
2%
Sepsis
2%
Femoral neck fracture
2%
Humerus fracture
2%
Squamous cell carcinoma of the tongue
2%
Peripheral ischaemia
2%
Throat irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pamrevlumab
Placebo
Sub-Study: Pamrevlumab+Pirfenidone
Sub-Study: Placebo+Pirfenidone
Sub-Study: Pamrevlumab+Nintedanib
Sub-Study: Placebo+Nintedanib
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PamrevlumabExperimental Treatment2 Interventions
Pamrevlumab 35 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks + systemic deflazacort or equivalent potency of corticosteroids administered orally for up to 52 weeks
Group II: PlaceboPlacebo Group2 Interventions
Matching placebo IV every 2 weeks + systemic deflazacort or equivalent potency of corticosteroids administered orally for up to 52 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pamrevlumab
2013
Completed Phase 3
~210
Corticosteroids
2003
Completed Phase 4
~8270
Find a Location
Who is running the clinical trial?
FibroGenLead Sponsor
58 Previous Clinical Trials
15,245 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken pamrevlumab before.You have had a severe allergic reaction to certain types of antibodies used in treatments.This text states that the average predicted FVC for both the screening test and the day 0 test falls within the range of 45 to 85%.is required
The text states that written consent by the patient and/or legal guardian is required in accordance with regional/country and/or IRB/IEC requirements., and enrolled in hospice services qualify for the study
Men 12 years of age or older who are non-ambulatory and enrolled in hospice services are eligible for the study.Male subjects who have partners who can become pregnant must use contraception during the study and for 3 months after the last dose of the study drug.The Brooke Score for Arms and Shoulders is a measurement of the range of motion in the shoulder and armTo be included in the study, people with cardiomyopathy must be taking a stable dose of medication for the condition for at least one month before screening.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Pamrevlumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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