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Monoclonal Antibodies

Pamrevlumab for Duchenne Muscular Dystrophy (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

MISSION Trial Summary

This trial is testing a new drug to see if it is safe and effective for people with Duchenne Muscular Dystrophy who cannot walk.

Eligible Conditions

Duchenne Muscular Dystrophy

MISSION Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Autoimmune haemolytic anaemia

Immune thrombocytopenic purpura

Non-cardiac chest pain

Acute respiratory failure

Respiratory failure

Angina pectoris

Sepsis

Femoral neck fracture

Humerus fracture

Musculoskeletal chest pain

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

MISSION 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.

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

Find a Location

Who is running the clinical trial?

FibroGenLead Sponsor

57 Previous Clinical Trials

15,283 Total Patients Enrolled

Media Library

Pamrevlumab (FG-3019) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02606136 — Phase 2

Duchenne Muscular Dystrophy Research Study Groups: Pamrevlumab

Duchenne Muscular Dystrophy Clinical Trial 2023: Pamrevlumab (FG-3019) Highlights & Side Effects. Trial Name: NCT02606136 — Phase 2

Pamrevlumab (FG-3019) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02606136 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned pamrevlumab (FG-3019) for medical use?

"The safety of pamrevlumab (FG-3019) is estimated to be a 2 since it has only been through Phase 2 trials, revealing preliminary evidence for its security but no proof of efficacy."

Answered by AI

Is this a pioneering medical experiment?

"To date, FibroGen has conducted 6 trials involving pamrevlumab (FG-3019) across 173 cities and 35 countries. This initiative began in 2016 with a Phase 2 study enrolling only 21 patients. However, since then the clinical investigation of this drug has grown considerably."

Answered by AI

Is this clinical experiment actively recruiting participants?

"This clinical trial is no longer accepting patients. It was posted on April 1st, 2016 and the last update occurred on November 30th 2021. For those seeking alternative trials for muscular dystrophy or pamrevlumab (FG-3019), there are presently 86 open studies and 6 actively recruiting respectively."

Answered by AI

What is the current enrollment population for this clinical investigation?

"This clinical trial has officially concluded its participant recruitment. It was first posted on April 1st 2016 and the last update occurred November 30th 2021. If you're still interested in participating, there are currently 86 trials involving muscular dystrophy or duchenne as well as 6 studies regarding pamrevlumab (FG-3019) that are actively taking volunteers."

Answered by AI

Could you elucidate on any prior research involving pamrevlumab (FG-3019)?

"Presently, there are 6 ongoing clinical trials for pamrevlumab (FG-3019), with 5 of them in the Phase 3 phase. Even though Busan and São Paulo are home to many of these studies, a grand total of 553 locations offer this treatment option."

Answered by AI

How many sites are engaged in the implementation of this trial?

"This experiment has recruited a number of patients from Washington University in St. Louis School of Medicine, Rare Disease Research located in Atlanta, Georgia and David Geffen School of Medicine at UCLA in Los Angeles California to mention but a few out of the 10 other locations."

Answered by AI

Recent research and studies

BiomoleculesJournal

CCN2 Binds to Tubular Epithelial Cells in the Kidney

Rayego-Mateos, Sandra, José Luis Morgado-Pascual, Carolina Lavoz, Raúl R. Rodrigues-Díez, Laura Márquez-Expósito, Antonio Tejera-Muñoz, Lucía Tejedor-Santamaría, Irene Rubio-Soto, Vanessa Marchant, and Marta Ruiz-Ortega. 2022. “CCN2 Binds to Tubular Epithelial Cells in the Kidney”. Biomolecules. MDPI AG. doi:10.3390/biom12020252.

clinicaltrials.govStudy

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

2016. "Trial of Pamrevlumab (FG-3019), in Non-Ambulatory Participants With Duchenne Muscular Dystrophy (DMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02606136.