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Monoclonal Antibodies

Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Participants With Duchenne Muscular Dystrophy (DMD) (MISSION Trial)

Phase 2

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 104

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing pamrevlumab, a medication that aims to block harmful proteins, in patients with Duchenne Muscular Dystrophy who cannot walk. The goal is to see if it is safe and effective over time. Pamrevlumab has shown potential in treating idiopathic pulmonary fibrosis in previous studies.

Eligible Conditions

Duchenne Muscular Dystrophy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 104

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 104

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 104 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Annual Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) at Week 104

Secondary study objectives

Cicatrization

Change From Baseline in Fat Fraction Percentage (%F), as Measured by MRI at Week 104

Change From Baseline in Grip Strength by Hand, as Measured by Hand Held Myometry (HHM) at Week 104

+6 more

Side effects data

From 2017 Phase 2 trial • 160 Patients • NCT01890265

30%

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

Pain

Headache

Upper-airway cough syndrome

Abdominal pain upper

Chest pain

Oedema peripheral

Dizziness

Insomnia

Sleep apnoea syndrome

Myalgia

Chest discomfort

Heart sounds abnormal

Decreased appetite

Musculoskeletal pain

Anxiety

Pulmonary hypertension

Sinus congestion

Flushing

Hypertension

Bronchitis

Constipation

Interstitial lung disease

Pulmonary embolism

Contusion

Musculoskeletal chest pain

Autoimmune haemolytic anaemia

Immune thrombocytopenic purpura

Non-cardiac chest pain

Acute respiratory failure

Respiratory failure

Angina pectoris

Sepsis

Femoral neck fracture

Humerus fracture

Squamous cell carcinoma of the tongue

Peripheral ischaemia

Throat irritation

100%

80%

60%

40%

20%

Study treatment Arm

Pamrevlumab

Placebo

Sub-Study: Pamrevlumab+Pirfenidone

Sub-Study: Placebo+Pirfenidone

Sub-Study: Pamrevlumab+Nintedanib

Sub-Study: Placebo+Nintedanib

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: PamrevlumabExperimental Treatment1 Intervention

Participants will receive pamrevlumab 35 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 2 weeks for a minimum of 104 weeks. Participants who complete the main study, will continue to receive pamrevlumab 35 mg/kg by IV infusion every 2 weeks for a minimum of up to 208 weeks in the OLE.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pamrevlumab

Not yet FDA approved

Do I qualify?Apply below to find out