DNL343 for ALS

Overseen By Healey Center for ALS at Massachusetts General Hospital

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Merit E. Cudkowicz, MD

Must not be taking: Cytochrome P450 inducers

Disqualifiers: Epilepsy, Seizure, Hypersensitivity, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

249 Participants Needed

Trial Summary

What is the purpose of this trial?

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen G will evaluate the safety and efficacy of a single study drug, DNL343, in participants with ALS.

Research Team

Merit Cudkowicz, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for people with ALS, also known as Lou Gehrig's disease. Participants must not have had a seizure in the last 6 months and cannot be taking certain medications that affect liver enzymes or drug transporters.

Inclusion Criteria

No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683).

Exclusion Criteria

I am not taking any medications that affect certain enzymes or drug transporters.

You are allergic to DNL343 or any of the ingredients in the DNL343 drug.

I have been diagnosed with epilepsy or had a seizure in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete a baseline assessment before randomization

1 week

1 visit (in-person)

Treatment

Participants receive either active DNL343 or matching placebo

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DNL343
• Matching Placebo

Trial Overview The HEALEY ALS Platform Trial - Regimen G is testing DNL343 against a placebo to see if it's safe and effective for treating ALS. Patients will either receive the actual drug or a dummy pill without knowing which one they're getting.

Participant Groups

Group I: DNL343 Experimental Treatment 1 Intervention

Group II: Matching Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Merit E. Cudkowicz, MD

Lead Sponsor

Trials

8

Recruited

2,900+

Denali Therapeutics Inc.

Industry Sponsor

Trials

24

Recruited

1,900+