Trial · NCT04632940

Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD

NCT04632940, Phase 3, Terminated, Kyntra Bio; results first posted 2024-08-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD. Trials, record NCT04632940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04632940

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 3 Trial of Pamrevlumab or Placebo in Combination With Systemic Corticosteroids in Participants With Ambulatory DMD
NCT number: NCT04632940
Status: Terminated
Phases: Phase 3
Enrollment: 73 participants, actual
Lead sponsor: Kyntra Bio
Conditions: Duchenne Muscular Dystrophy
Interventions: Pamrevlumab, Placebo, Corticosteroids
First posted: 2020-11-17
Last updated: 2024-08-26
Other registries' IDs: eudract:2020-000699-39
Results first posted: 2024-08-26

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52	Baseline, Week 52	The NSAA consisted of 17 activities, each scored as 0 (activity could not be performed), 1 (modified method but achieved goal without physical assistance from another), or 2 (normal, achieved goal without assistance). The sum of these 17 scores was used to form a total score ranging from 0 (worst) to 34 (fully independent function). If fewer than 15 of the 17 activities were performed, the total score was considered missing. If 15 to 16 activities were performed, the total score was calculated by multiplying the sum of the scores in the x activities that were performed by 17/x. If an activity could not be performed due to disease progression/loss of ambulation, a score of 0 was assigned. Higher scores indicated better functioning. Least square (LS) mean and standard error (SE) were analyzed using a mixed model for repeated measure (MMRM).
Secondary	Change From Baseline in 4-Stair Climb Velocity (4SCV) Assessment at Week 52	Baseline, Week 52	The 4SCV (centimeters \[cm\]/second \[sec\]) was calculated as the ratio of the total height (cm) of stairs climbed divided by the number of seconds taken to complete the 4-stair climb.
Secondary	Change From Baseline in the 10-Meter Walk/Run Test at Week 52	Baseline, Week 52	The time (in sec) required for a participant to run or walk a distance of 10 meters as quickly as possible was calculated as velocity (meters/sec).
Secondary	Change From Baseline in Time to Stand (TTSTAND) at Week 52	Baseline, Week 52	The time (in sec) required for a participant to stand from supine position has been reported. A longer time taken reflected a worse outcome.
Secondary	Time to Loss of Ambulation (LoA) From Baseline to Week 52	Baseline to Week 52	Time (days) to LoA was defined as the number of days from randomization to the date of LoA, or all-cause death based on observed data, whichever occurred earlier during the on-study period. Median time (days) to LoA was calculated using Kaplan Meier Survival Estimates.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52	Baseline, Week 52	The ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 4-Stair Climb Velocity (4SCV) Assessment at Week 52	Baseline, Week 52	The ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	cm/sec	MEAN
SECONDARY	Change From Baseline in the 10-Meter Walk/Run Test at Week 52	Baseline, Week 52	The ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	meters/sec	MEAN
SECONDARY	Change From Baseline in Time to Stand (TTSTAND) at Week 52	Baseline, Week 52	The ITT set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.	sec	MEAN
SECONDARY	Time to Loss of Ambulation (LoA) From Baseline to Week 52	Baseline to Week 52	The ITT set included all randomized participants.	days	MEDIAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52	Pamrevlumab	-3.022	Standard Error 0.5505	units on a scale
Change From Baseline in North Star Ambulatory Assessment (NSAA) Total Score at Week 52	Placebo	-2.494	Standard Error 0.6962	units on a scale
Change From Baseline in 4-Stair Climb Velocity (4SCV) Assessment at Week 52	Pamrevlumab	-1.858	Standard Deviation 4.5459	cm/sec
Change From Baseline in 4-Stair Climb Velocity (4SCV) Assessment at Week 52	Placebo	-3.797	Standard Deviation 5.1899	cm/sec
Change From Baseline in the 10-Meter Walk/Run Test at Week 52	Pamrevlumab	-0.176	Standard Deviation 0.2193	meters/sec
Change From Baseline in the 10-Meter Walk/Run Test at Week 52	Placebo	-0.196	Standard Deviation 0.3552	meters/sec
Change From Baseline in Time to Stand (TTSTAND) at Week 52	Pamrevlumab	2.24	Standard Deviation 3.353	sec
Change From Baseline in Time to Stand (TTSTAND) at Week 52	Placebo	1.94	Standard Deviation 3.688	sec
Time to Loss of Ambulation (LoA) From Baseline to Week 52	Pamrevlumab	NA	95% Confidence Interval NA to NA	days
Time to Loss of Ambulation (LoA) From Baseline to Week 52	Placebo	NA	95% Confidence Interval NA to NA	days

Source ClinicalTrials.gov

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
DB Period (52 Weeks)	STARTED	Pamrevlumab	37
DB Period (52 Weeks)	STARTED	Placebo	36
DB Period (52 Weeks)	Received at Least 1 Dose of Study Drug	Pamrevlumab	36
DB Period (52 Weeks)	Received at Least 1 Dose of Study Drug	Placebo	36
DB Period (52 Weeks)	COMPLETED	Pamrevlumab	35
DB Period (52 Weeks)	COMPLETED	Placebo	36
DB Period (52 Weeks)	NOT COMPLETED	Pamrevlumab	2
DB Period (52 Weeks)	NOT COMPLETED	Placebo	0
OLE Period (52 Weeks)	STARTED	Pamrevlumab	34
OLE Period (52 Weeks)	STARTED	Placebo	35

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events132

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal discomfort	Gastrointestinal disorders	DB Period: Pamrevlumab	0	36
other	Abdominal discomfort	Gastrointestinal disorders	DB Period: Placebo	2	36
other	Abdominal discomfort	Gastrointestinal disorders	OLE Period: Pamrevlumab	0	68
other	Abdominal pain	Gastrointestinal disorders	DB Period: Pamrevlumab	5	36
other	Abdominal pain	Gastrointestinal disorders	DB Period: Placebo	3	36
other	Abdominal pain	Gastrointestinal disorders	OLE Period: Pamrevlumab	2	68
other	Abdominal pain upper	Gastrointestinal disorders	DB Period: Pamrevlumab	2	36
other	Abdominal pain upper	Gastrointestinal disorders	DB Period: Placebo	1	36
other	Abdominal pain upper	Gastrointestinal disorders	OLE Period: Pamrevlumab	3	68
other	Constipation	Gastrointestinal disorders	DB Period: Pamrevlumab	0	36

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DB Period: Pamrevlumab	0	37
Total, all-cause mortality	DB Period: Placebo	0	36
Total, all-cause mortality	OLE Period: Pamrevlumab	0	69
Total, other adverse events	DB Period: Pamrevlumab	35	36
Total, other adverse events	DB Period: Placebo	33	36
Total, other adverse events	OLE Period: Pamrevlumab	45	68
Total, serious adverse events	DB Period: Pamrevlumab	3	36
Total, serious adverse events	DB Period: Placebo	1	36
Total, serious adverse events	OLE Period: Pamrevlumab	0	68

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04632940

GET https://conductscience.org/api/trials/v1/NCT04632940/events?page=2

API reference For AI assistants