A Phase 2 interventional study of Pamrevlumab in Duchenne Muscular Dystrophy, sponsored by FibroGen. Terminated at 10 sites in United States. Open to male participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by FibroGen · Phase 2, Interventional, and Treatment
Among 232 studies in Muscular Dystrophy, Duchenne with a site in United States — 35 open to participants now, 60 under way, 8 of them phase 3. Muscular Dystrophy, Duchenne · United States.
Among the 232 studies in Muscular Dystrophy, Duchenne with a site in United States, this one is the 94th largest by enrollment of the 171 interventional ones that give a count, is one of 15 that started in 2016, is one of 57 in phase 2, and was the 95th registered.
481 studies on the registry are indexed under Muscular Dystrophy, Duchenne; 107 are open to participants now.
Browse Muscular Dystrophy, Duchenne studies →35 of the 232 studies in Muscular Dystrophy, Duchenne with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt University Medical Center · Sites in United States
Ages 18+ · Men only
Sarepta Therapeutics, Inc. · Sites in United States
Ages 4+ · Men only
University of Florida · Sites in United States
Ages 6+ · Men only
Vanderbilt University Medical Center · Sites in United States
Ages 8–18 · Men only
University of Rochester · Sites in United States
Ages 0 days–3 yrs · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 66 Muscular Dystrophy, Duchenne studies recruiting now, 30 (45%) set no upper age limit and 34 (52%) stop at 75 or younger; 59 take children under 18; 12 take healthy volunteers.
This study: 12 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
232 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 57 · Phase 2 90 · Phase 3 40 · Phase 4 5
First in 2000; this study’s year is marked. 15 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 21 is below the median of 26 across 332 interventional studies indexed under Muscular Dystrophy, Duchenne.
Median enrollment 25 across the 171 interventional studies, 75 across the 55 observational. Of the 160 that completed or were terminated, 78 (49%) have results posted.
This tab as a report to print or save as PDF → With an account.
130 of 232 have an industry lead sponsor. The 10 most frequent:
This study is registered under FibroGen, one of the names counted as Kyntra Bio. Under that name alone:
FibroGen is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Kyntra Bio has 3 studies filed under Muscular Dystrophy, Duchenne — fewer than ten, so there is no comparison to draw.
19 of the studies in Muscular Dystrophy, Duchenne with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05881408Phase 3Sarepta Therapeutics, Inc.A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) in Non-Ambulatory and Ambulatory Participants With Duchenne Muscular Dystrophy (DMD) | 2027-05-31 |
| NCT06290713University of FloridaVasodilator and Exercise Study for DMD (VASO-REx) | 2026-11 |
| NCT06450639Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) | 2026-11-18 |
| NCT03368742Solid Biosciences Inc.Microdystrophin Gene Transfer Study in Adolescents and Children With DMD | 2026-11-30 |
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
Add all 19 to your calendar (.ics) → With an account.
Among the 232 studies in Muscular Dystrophy, Duchenne with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a Phase 2, open-label, single arm trial of pamrevlumab (FG-3019) to estimate pamrevlumab's safety and efficacy in non-ambulatory participants with DMD.
The study will include a screening period, main study period, open-label extension (OLE) period, and follow-up period 4 weeks after the last dose. All participants who complete the main portion of the study for a minimum of 104 weeks (2 years) will be rolled over to an OLE for up to an additional 208 weeks (4 years).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate hematological function
Adequate hepatic function
Exclusion Criteria:
Severe uncontrolled heart disease, including any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Pamrevlumab
Pamrevlumab, 10 milligrams (mg)/milliliter (mL), single dose vials
Also known as: Monoclonal Antibody to Connective tissue growth factor (CTGF), FG-3019
Annual Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) at Week 104
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Analysis was done using a random coefficient model (RCM), which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
Change From Baseline in Percent Predicted Forced Expiratory Volume at 1 Second (ppFEV1) at Week 104
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1= (observed value)/(predicted value) \* 100%. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 104
Percent predicted PEF is a measure of the maximal or peak flow produced during an exhalation with maximal effort and, as such, is the most effort-dependent measure of lung function. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
Change From Baseline in Left Ventricular Ejection Fraction Percentage (LVEF%) at Week 104
LVEF% is an important measure of cardiac function. LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
Change From Baseline in Performance of Upper Limb (PUL) Total Score at Week 104
The PUL module is an observer-administered performance battery of upper extremity mobility tasks for the shoulder (upper, 6 items: maximum score = 12), elbow (middle, 9 items: maximum score = 17) and wrist/hand (distal, 7 items: maximum score = 13). Higher scores of each item indicate higher level of function. Total score was calculated by adding the 3 level scores, with a maximum global score of 42 (total score range = 0-42; with higher score indicating better outcome). Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
Change From Baseline in Grip Strength by Hand, as Measured by Hand Held Myometry (HHM) at Week 104
The HHM was used to measure distal upper arm strength (grip strength). Data has been presented by dominant and non-dominant hand. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
Change From Baseline in Pinch Strength, as Measured by HHM at Week 104
The HHM was used to measure distal upper arm strength (pinch strength). Data has been presented by dominant and non-dominant hand. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
Change From Baseline in Cardiac Fibrosis (Scar Mass), as Measured by Magnetic Resonance Imaging (MRI) at Week 104
Cardiac MRI was used to assess the cardiac fibrosis by detecting the presence of late gadolinium enhancement (LGE), a marker for myocardial fibrosis. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
Change From Baseline in Upper Arm (Biceps Brachii MRI) Muscle Fat and Fibrosis Score, as Measured by MRI at Week 104
T2-mapping with MRI was conducted to measure upper arm muscle fibrosis and fat in the biceps brachii muscle. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect. The visual score for muscle fat and fibrosis will be assessed using a modified 5-point Mercuri score in which 0 = normal muscle appearance and 5 = complete replacement of muscle by connective tissue and fat, where a lower score indicated visually healthier muscle. Change from baseline was calculated as the score at Week 104 - the score at baseline.
Time frame: Baseline, Week 104
Change From Baseline in Fat Fraction Percentage (%F), as Measured by MRI at Week 104
Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
Time frame: Baseline, Week 104
| Milestone | Pamrevlumab |
|---|---|
| Started | 21 |
| Received at least 1 dose of study drug | 21 |
| Completed | 15 |
| Not completed | 6 |
| Withdrew: Participant/legal guardian decision | 5 |
| Withdrew: Withdrawal by subject | 1 |
| Milestone | Pamrevlumab |
|---|---|
| Started | 15 |
| Received at least 1 dose of study drug | 15 |
| Completed | 0 |
| Not completed | 15 |
| Withdrew: Participant/legal guardian decision | 1 |
| Withdrew: Sponsor decision to terminate study | 14 |
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) \* 100%. Analysis was done using a random coefficient model (RCM), which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| percentage of predicted FVC | Pamrevlumab |
|---|---|
| Annual Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) at Week 104 | -4.17 ± 0.655 |
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Predicted FEV1 is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FEV1= (observed value)/(predicted value) \* 100%. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| percentage of predicted FEV1 | Pamrevlumab |
|---|---|
| Change From Baseline in Percent Predicted Forced Expiratory Volume at 1 Second (ppFEV1) at Week 104 | -8.32 ± 1.217 |
Percent predicted PEF is a measure of the maximal or peak flow produced during an exhalation with maximal effort and, as such, is the most effort-dependent measure of lung function. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| percentage of predicted PEF | Pamrevlumab |
|---|---|
| Change From Baseline in Percent Predicted Peak Expiratory Flow (PEF) at Week 104 | -7.13 ± 2.313 |
LVEF% is an important measure of cardiac function. LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| percentage of LVEF | Pamrevlumab |
|---|---|
| Change From Baseline in Left Ventricular Ejection Fraction Percentage (LVEF%) at Week 104 | -2.73 ± 1.651 |
The PUL module is an observer-administered performance battery of upper extremity mobility tasks for the shoulder (upper, 6 items: maximum score = 12), elbow (middle, 9 items: maximum score = 17) and wrist/hand (distal, 7 items: maximum score = 13). Higher scores of each item indicate higher level of function. Total score was calculated by adding the 3 level scores, with a maximum global score of 42 (total score range = 0-42; with higher score indicating better outcome). Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| unit on a scale | Pamrevlumab |
|---|---|
| Change From Baseline in Performance of Upper Limb (PUL) Total Score at Week 104 | -4.14 ± 0.651 |
The HHM was used to measure distal upper arm strength (grip strength). Data has been presented by dominant and non-dominant hand. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| newton | Pamrevlumab |
|---|---|
| Dominant Grip Best Result | -2.52 ± 3.610 |
| Non-Dominant Grip Best Result | -1.31 ± 3.591 |
The HHM was used to measure distal upper arm strength (pinch strength). Data has been presented by dominant and non-dominant hand. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| newton | Pamrevlumab |
|---|---|
| Dominant Pinch Best Result | -4.24 ± 1.547 |
| Non-Dominant Pinch Best Result | -3.46 ± 1.378 |
Cardiac MRI was used to assess the cardiac fibrosis by detecting the presence of late gadolinium enhancement (LGE), a marker for myocardial fibrosis. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| grams | Pamrevlumab |
|---|---|
| Change From Baseline in Cardiac Fibrosis (Scar Mass), as Measured by Magnetic Resonance Imaging (MRI) at Week 104 | 3.74 ± 4.475 |
T2-mapping with MRI was conducted to measure upper arm muscle fibrosis and fat in the biceps brachii muscle. Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect. The visual score for muscle fat and fibrosis will be assessed using a modified 5-point Mercuri score in which 0 = normal muscle appearance and 5 = complete replacement of muscle by connective tissue and fat, where a lower score indicated visually healthier muscle. Change from baseline was calculated as the score at Week 104 - the score at baseline.
| unit on scale | Pamrevlumab |
|---|---|
| Change From Baseline in Upper Arm (Biceps Brachii MRI) Muscle Fat and Fibrosis Score, as Measured by MRI at Week 104 | -2.22 ± 1.088 |
Analysis was done using an RCM, which included visit in years (as a continuous variable), and baseline efficacy as fixed effects, the intercept and the linear slope of visit as random effect, and individual participants as participant effect.
| percentage of fat | Pamrevlumab |
|---|---|
| Change From Baseline in Fat Fraction Percentage (%F), as Measured by MRI at Week 104 | 4.49 ± 2.030 |
Collected over Baseline up to Week 210. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Main Study: Pamrevlumab | 0/21 (0%) | 6/21 (28.6%) | 21/21 (100%) |
| OLE: Pamrevlumab | 0/15 (0%) | 5/15 (33.3%) | 15/15 (100%) |
| Event | Main Study: Pamrevlumab | OLE: Pamrevlumab |
|---|---|---|
| Retinal exudatesEye disorders | 0/21 | 1/15 |
| CholecystitisHepatobiliary disorders | 0/21 | 1/15 |
| COVID-19Infections and infestations | 0/21 | 1/15 |
| Catheter site abscessInfections and infestations | 0/21 | 1/15 |
| Pilonidal diseaseInfections and infestations | 0/21 | 1/15 |
| Food poisoningGastrointestinal disorders | 1/21 | 0/15 |
| Adverse drug reactionGeneral disorders | 1/21 | 0/15 |
| PneumoniaInfections and infestations | 1/21 | 0/15 |
| ConcussionInjury, poisoning and procedural complications | 1/21 | 0/15 |
| Femur fractureInjury, poisoning and procedural complications | 1/21 | 0/15 |
| Event | Main Study: Pamrevlumab | OLE: Pamrevlumab |
|---|---|---|
| HeadacheNervous system disorders | 14/21 | 4/15 |
| NasopharyngitisInfections and infestations | 11/21 | 3/15 |
| VomitingGastrointestinal disorders | 10/21 | 2/15 |
| CoughRespiratory, thoracic and mediastinal disorders | 9/21 | 4/15 |
| PyrexiaGeneral disorders | 8/21 | 1/15 |
| Back painMusculoskeletal and connective tissue disorders | 8/21 | 3/15 |
| NauseaGastrointestinal disorders | 7/21 | 2/15 |
| Sinus congestionRespiratory, thoracic and mediastinal disorders | 6/21 | 1/15 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 4/21 | 4/15 |
| COVID-19Infections and infestations | 0/21 | 4/15 |
Intent-to-treat (ITT) population included all participants who enrolled in the study.
| Age, Continuous(years) | Pamrevlumab |
|---|---|
| Mean | 15.99 ± 3.277 |
| Sex: Female, Male(Participants) | Pamrevlumab |
|---|---|
| Female | 0 |
| Male | 21 |
| Ethnicity (NIH/OMB)(Participants) | Pamrevlumab |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Pamrevlumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Percent Predicted Forced Vital Capacity (ppFVC)(percentage of predicted FVC) | Pamrevlumab |
|---|---|
| Mean | 54.15 (29.1 to 70.7) |
| Percent Predicted Peak Expiratory Flow (PEF)(percentage of predicted PEF) | Pamrevlumab |
|---|---|
| Mean | 54.66 (37.9 to 82.7) |
| Percent Predicted Forced Expiratory Volume at 1 Second (ppFEV1)(percentage of predicted FEV1) | Pamrevlumab |
|---|---|
| Mean | 53.815 (29.24 to 73.35) |
| Left Ventricular Ejection Fraction Percentage (LVEF%)(percentage of LVEF) | Pamrevlumab |
|---|---|
| Mean | 56.992 (41.03 to 73.81) |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jan 2016 to primary completion in May 2020, 52 months.
Results were first posted in Dec 2021, 1 year 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pamrevlumab
Muscular Dystrophy, Duchenne →