NCT07082192

A Study to Evaluate the Efficacy and Safety of Different Doses of CB03-154 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Adaptive Clinical Study and Open-label Extension Study to Evaluate the Efficacy and Safety of Different Doses of CB03-154 in Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Shanghai Zhimeng Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if drug CB03-154 works to treat ALS in adults. It will also learn about the safety of drug CB03-154. The main questions it aims to answer are: * Does drug CB03-154 have an effect on delaying disease progression, improving function, and prolonging survival in adult ALS patients? * What medical problems do patients have when taking drug CB03-154? Researchers will compare drug CB03-154 to a placebo (a look-alike substance that contains no drug) to see if drug CB03-154 works to treat ALS. Participants (adult ALS patients) will: * Take drug CB03-154 or a placebo every day for 39 weeks (an additional 39 weeks would be required if entering the open-label extension phase). * Visit the clinic approximately every 2-3 months for checkups and tests, and there is also telephone follow-up in between. * Keep a diary of daily medication (CB03-154 or other concomitant medications), and if there are any unplanned medications, the reason (disease or symptoms) also need be recorded.

Conditions

• ALS (Amyotrophic Lateral Sclerosis)

Interventions

Type	Name	Description
DRUG	Test drug CB03-154 5mg group	One CB03-154 tablet (5mg/tablet) once daily.
DRUG	Test drug CB03-154 10mg group	Two CB03-154 tablets (5mg/tablet) once daily.
DRUG	Test drug CB03-154 15mg group	Three CB03-154 tablets (5mg/tablet) once daily.
DRUG	Placebo Group	Three Placebo tablets once daily.

Timeline

• Start date: 2025-09-29
• Primary completion: 2027-09-30
• Completion: 2027-10-01
• First posted: 2025-07-24
• Last updated: 2025-07-24