UNITE-ALS

In the UNITE-ALS study the safety and tolerability of the drug usnoflast in participants with ALS is assessed, and it is determined whether usnoflast can slow down the worsening of the disease. The study is sponsored by Zydus Therapeutics Inc.

Usnoflast

Usnoflast is an investigational medicine designed to block a specific protein that causes neuro-inflammation in the body. In ALS, neuro-inflammation can damage the nerve cells that control muscles. By reducing this neuro-inflammation, Usnoflast may possibly help protect these cells and slow the loss of muscle strength and control.

Usnoflast can be taken orally through capsules.

Study Design

This is a phase 2b study. The aim of the study is to assess the safety and tolerability of the drug Usnoflast in participants with ALS, and to determine whether Usnoflast can slow down the worsening of the disease.

The study is randomized, double-blind, and placebo-controlled.

Participants will be divided into three groups in this study. One group will take 50 mg of Usnoflast twice daily, the second group will take 75 mg of Usnoflast twice daily, and the third group will take placebo capsules twice daily. Every group will go through the same tests and procedures.

A placebo is a treatment that looks like Usnoflast but does not contain any active medicine. Placebos are used to compare the results of the study medicine to the results of no active treatment. Each participant is assigned randomly (randomization) into one of the three treatment groups. Neither you nor the investigators will know who is getting the real medicine or the placebo (double-blind).

The study lasts 56 weeks. You will need to visit the hospital at least a total of 8 times. Visits may last several hours, with some taking up to 8 hours. Additional safety visits are also required; these may be conducted during a home visit or at the hospital.

The study is split into different periods:

Screening (28 days): During the screening period, you will be checked to see if you are eligible to join the study.

Double-blinded treatment period (36 weeks): After the screening, and if you are found eligible to participate in the study, you’ll enter the double-blinded treatment period. During this period, you will receive either a placebo or one of the two doses of Usnoflast, as explained above.

Open-Label Extension (OLE) Study (16 weeks): If you complete the 36-week treatment period, you will have the option to join a 16-week open-label extension study, during which all participants receive 75 mg of Usnoflast. During this period, you will need to visit the hospital a total of 3 times. Additional safety visits are also required; these may be conducted during a home visit or at the hospital.

Can I participate in the study?

The main criteria to participate in this study are:

• You are 18 years of age or older
• Diagnosis of ALS
• The first symptom that led to the ALS diagnosis must have started within 24 months before your first visit for this study.
• Your lung function test result is at least 60%
• If you take medication for ALS, your treatment must have been stable for at least 28 days.
• You are able to swallow oral capsules

Note: This list is not exhaustive, but these are the main criteria.

Registration and more information

To learn more about participating in the UNITE-ALS trial, please contact one of the participating TRICALS centres below (contact details can be found by clicking on ‘More about this centre’). Make use of the contact form on each Centre detail page, or when contacting the centre of your choice by email or telephone, please provide your full name, your date of birth and the date of onset of symptoms. The centre can provide you with more information about the trial and/or inclusion criteria and answer any questions you may have. If you experience difficulty contacting a centre, you may reach out directly to the TRICALS operational team at info@tricals.org for support in this process.

More information about the trial can be found at clinicaltrials.gov