Trial · NCT06351592
First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)
NCT06351592, Phase 1, Phase 2, Recruiting, Regeneron Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS). Trials, record NCT06351592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06351592
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS)
- NCT number
- NCT06351592
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 54 participants, estimated
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Amyotrophic Lateral Sclerosis (ALS), Mutation in the Superoxide Dismutase-1 (SOD1) Gene
- Interventions
- ALN-SOD, Diluent, Placebo (PB)
- First posted
- 2024-04-08
- Last updated
- 2026-09-11
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Event (TEAEs) in participants treated with ALN-SOD | At week 4 and through week 228 | |
| Primary | Severity of TEAEs in participants treated with ALN-SOD | At week 4 and through week 228 | |
| Secondary | Concentration of Neurofilament Light chain (NfL) in plasma over time | Up to approximately week 228 | |
| Secondary | Change in concentration of NfL in plasma over time | Up to approximately week 228 | |
| Secondary | Concentration of SOD1 protein in Cerebrospinal Fluid (CSF) over time | Up to approximately week 228 | |
| Secondary | Change in concentration of SOD1 protein in CSF over time | Up to approximately week 228 | |
| Secondary | Concentration of NfL in CSF over time | Up to approximately week 228 | |
| Secondary | Change in concentration of NfL in CSF over time | Up to approximately week 228 | |
| Secondary | Change in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) over time | Up to approximately week 228 | |
| Secondary | Concentration of ALN-SOD in plasma over time | Up to approximately week 228 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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.
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/NCT06351592
GET https://conductscience.org/api/trials/v1/NCT06351592/registered