Trial · NCT05842941

HEALEY ALS Platform Trial - Regimen G DNL343

NCT05842941, Phase 2, Phase 3, Completed, Merit E. Cudkowicz, MD; results first posted 2026-01-28

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. HEALEY ALS Platform Trial - Regimen G DNL343. Trials, record NCT05842941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05842941

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Trial

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

Title: HEALEY ALS Platform Trial - Regimen G DNL343
NCT number: NCT05842941
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 249 participants, actual
Lead sponsor: Merit E. Cudkowicz, MD
Conditions: Amyotrophic Lateral Sclerosis
Interventions: DNL343, Matching Placebo
First posted: 2023-05-06
Last updated: 2026-01-28
Results first posted: 2026-01-28

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Disease Progression as Assessed by the ALSFRS-R-Slope	Baseline to 24 Weeks	Change in disease severity as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) total score using a Bayesian repeated measures model that accounts for loss to follow-up due to mortality. Each of 12 questions assessing distinct functional ability is scored from 4(normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Participants with higher scores have more physical function. Note that only participants who survived to their Week 24 visit contribute to the estimate.
Primary	Mortality Event Rate	Baseline to 24 weeks	The Mortality Rate, presented as mean deaths per month, was estimated from a Bayesian shared-parametric model that assumed exponentially distributed survival times. Mortality is defined as death or death equivalent. A participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row.
Secondary	ALSFRS-R Total Score	Baseline to 24 Weeks	Change in ALSFRS-R total score over time. Each type of function is scored from 4 (normal) to 0 (no ability), with a maximum total score of 48 and a minimum total score of 0. Participants with higher scores have more physical function.
Secondary	Combined Assessment of Function and Survival (CAFS)	Baseline to 24 Weeks	Combined assessment of function and survival (CAFS) ranks participants' clinical outcomes based on survival time and change in the functional score. Each participant's outcome is compared to every other participant's outcome, assigned a score, and the summed scores are ranked. The mean rank score for each treatment group can then be calculated. A higher mean CAFS rank score indicates a better group outcome. The survival outcome is death or death-equivalent, where a participant is determined to meet the criteria of death equivalent if permanent assisted ventilation (PAV) is used for more than 22 hours per day for more than seven days in a row. The functional outcome is the ALS Functional Rating Scale-Revised (ALSFRS-R) score with a maximum total score of 48 and a minimum total score of 0. Participants with higher scores have more physical function.
Secondary	Respiratory Function	Baseline to 24 Weeks	Change in respiratory function over time as assessed by slow vital capacity (SVC)
Secondary	Upper Limb Muscle Strength	24 weeks	Change in upper limb muscle strength over time as measured isometrically using hand-held dynamometry and grip strength, calculated as the average percent change from baseline of the following muscles/maneuvers: shoulder flexion, elbow flexion, elbow extension, wrist extension, abductor pollicis brevis contraction, abductor digiti minimi contraction, first dorsal interosseous contraction, and grip strength. Note that only those with measurable strength at baseline were included.
Secondary	Number of Participants With Death or Permanent Assisted Ventilation (PAV)	Baseline to 24 weeks	The number of participants who died or met the criterion for a death equivalent from the date of their baseline visit to the end of the Week 24 visit window (generally 175 days after baseline). The death equivalent criterion is use of permanent assisted ventilation (PAV) for more than 22 hours per day for more than 7 days in a row.
Secondary	Number of Participants Who Experience Death	Baseline to 24 weeks	The number of participants who died from the date of their baseline visit to the end of the Week 24 visit window (generally 175 days after baseline).
Secondary	Disease Progression Biomarker	Baseline to 24 weeks	Change in log-transformed serum neurofilament light protein (NfL) concentration from baseline to Week 24

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Progression as Assessed by the ALSFRS-R-Slope	Baseline to 24 Weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	Percent change	MEAN
SECONDARY	ALSFRS-R Total Score	Baseline to 24 Weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	Points	LEAST_SQUARES_MEAN
SECONDARY	Combined Assessment of Function and Survival (CAFS)	Baseline to 24 Weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	Rank	LEAST_SQUARES_MEAN
SECONDARY	Respiratory Function	Baseline to 24 Weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	24-week diff. of percents of normal VC	LEAST_SQUARES_MEAN
SECONDARY	Upper Limb Muscle Strength	24 weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	Percent change	LEAST_SQUARES_MEAN
PRIMARY	Mortality Event Rate	Baseline to 24 weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	Events per month	MEAN
SECONDARY	Number of Participants With Death or Permanent Assisted Ventilation (PAV)	Baseline to 24 weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Experience Death	Baseline to 24 weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Disease Progression Biomarker	Baseline to 24 weeks	Outcome measure data was analyzed using the Efficacy Concurrent-controls Set (ECC), which included concurrent shared placebos from other regimens if randomized within 180 days of the first and last randomization for the applicable regimen, excluding any shared placebos also include in the focal regimen, as pre-specified in the Regimen Statistical Analysis Plan. Regimen F (NCT#05740813) and Regimen G (NCT#05842941) contributed placebo participants into the shared placebo cohort used for analysis.	ng/L	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Value	Spread	Units
Disease Progression as Assessed by the ALSFRS-R-Slope	DNL343	-0.88	Standard Deviation 0.062	Percent change
Disease Progression as Assessed by the ALSFRS-R-Slope	Matching Placebo	-0.84	Standard Deviation 0.081	Percent change
ALSFRS-R Total Score	DNL343	-5.759	Standard Deviation 0.3810	Points
ALSFRS-R Total Score	Matching Placebo	-5.726	Standard Deviation 0.4325	Points
Combined Assessment of Function and Survival (CAFS)	DNL343	152.10	Standard Error 9.622	Rank
Combined Assessment of Function and Survival (CAFS)	Matching Placebo	162.39	Standard Error 7.328	Rank
Respiratory Function	DNL343	-12.259	Standard Error 1.4904	24-week diff. of percents of normal VC
Respiratory Function	Matching Placebo	-9.692	Standard Error 1.6572	24-week diff. of percents of normal VC
Upper Limb Muscle Strength	DNL343	-33.787	Standard Error 2.4649	Percent change
Upper Limb Muscle Strength	Matching Placebo	-38.573	Standard Error 2.7828	Percent change

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	DNL343	186
Overall Study	STARTED	Matching Placebo	63
Overall Study	COMPLETED	DNL343	156
Overall Study	COMPLETED	Matching Placebo	55
Overall Study	NOT COMPLETED	DNL343	30
Overall Study	NOT COMPLETED	Matching Placebo	8

Source ClinicalTrials.gov

Adverse events118

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	Events
other	Constipation	Gastrointestinal disorders	DNL343	30	186	31
other	Constipation	Gastrointestinal disorders	Matching Placebo	7	63	7
other	Diarrhoea	Gastrointestinal disorders	DNL343	20	186	25
other	Diarrhoea	Gastrointestinal disorders	Matching Placebo	8	63	10
other	Nausea	Gastrointestinal disorders	DNL343	17	186	19
other	Nausea	Gastrointestinal disorders	Matching Placebo	4	63	4
other	Salivary hypersecretion	Gastrointestinal disorders	DNL343	14	186	14
other	Salivary hypersecretion	Gastrointestinal disorders	Matching Placebo	2	63	2
other	Fatigue	General disorders	DNL343	41	186	49
other	Fatigue	General disorders	Matching Placebo	10	63	10

1 to 10 of 118Source ClinicalTrials.gov

See all 118 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DNL343	6	186
Total, all-cause mortality	Matching Placebo	3	63
Total, other adverse events	DNL343	149	186
Total, other adverse events	Matching Placebo	43	63
Total, serious adverse events	DNL343	28	186
Total, serious adverse events	Matching Placebo	10	63

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42771346	DERIVED

Source PubMed

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 comparisons4

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

Comparison	Source
DNL343 vs Matching Placebo: Number of Participants Who Experience Death	Trial comparisons
DNL343 vs Matching Placebo: deaths from any cause	Trial comparisons
DNL343 vs Matching Placebo: Number of Participants With Death or Permanent Assisted Ventilation (PAV)	Trial comparisons
DNL343 vs Matching Placebo: serious adverse events	Trial comparisons

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/NCT05842941

GET https://conductscience.org/api/trials/v1/NCT05842941/events?page=2

API reference For AI assistants