Industry Sponsored Clinical trials

Together study

Brief summary

The purpose of the Phase 2 study was to investigate the effect of Bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer’s Disease (AD). Bepranemab is a monoclonal antibody, directed against human Tau. This drug is administered intravenously every month.

No new participants can be included in this study.

More information

Sponsor: UCB

Principal Investigator: prof. dr. Siddhartha Lieten

Status: Completed

SARA-INT study

Brief summary:

SARA-INT PHASE 2B INTERVENTIONAL CLINICAL TRIAL

We have currently tested the safety and efficacy of Sarconeos (BIO101) in a global, randomized, multicenter, double-blind, placebo-controlled Phase 2 clinical trial in sarcopenia (SARA-INT).

The last patient out was in December 2020. From the 233 initially enrolled in the 22 centers in the US and Belgium, 196 participants with sarcopenia at risk of mobility disability completed the study.

Top line results of SARA-INT Phase 2 study with Sarconeos (BIO101) in Sarcopenia have been announced on August 02, 2021.

Sarconeos (BIO101) at the highest dose (350 mg bid) showed a clinically meaningful improvement in the 400-meter walk test (400MWT), the primary endpoint of the study

Sarconeos (BIO101) showed a very good safety profile at the doses of 175 mg bid and of 350 mg bid with no Serious Adverse Events (AE) related to the product. Sarconeos (BIO101) now has the potential to be the first drug candidate to enter Phase 3 in sarcopenia. Biophytis has received approval to initiate the SARA-31 study in Belgium and the United States in the second half of 2023. Approvals may be sought in other countries, depending on the needs of the study. The effective start of the study is planned for 2024 and will depend on the conclusion of partnership agreements and the Company’s financial resources.

The primary endpoint of this Phase 3 trial as presented to the agencies is the ability to complete the 400m walk test in less than 15 minutes. This primary endpoint will be supplemented by the following secondary endpoints: Gait speed 4-m from SPPB, grip strength (HGS) and Patient Reported Outcome (PRO).

Sponsor: Biophytis

Principal Investigator: prof. dr. Ivan Bautmans

Status: Completed

DEMAIN study

Brief summary

This clinical study focuses on diagnostic markers to determine sarcopenia, a disease related to aging. Sarcopenia is a disease characterized by the gradual and simultaneous loss of weight, strength, and muscle function with aging. Although the World Health Organization (WHO) only recognized sarcopenia as a disease in April 2016, it is estimated that today more than 50 million people worldwide suffer from it, and approximately 200 million people will be affected by it in 2050. To investigate whether you suffer from sarcopenia, a combination of physical examinations and imaging studies using magnetic resonance imaging (MRI, commonly known as a "scanner") is used today. These studies are expensive and complicated for everyone. This study aims to focus on new biological markers (in blood and muscle biopsy) for sarcopenia to make it easier to determine sarcopenia.

Sponsor: Artialis

Principal Investigator: prof. dr. Ivan Bautmans

Status: Completed

Tauriel study

Brief summary

This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.

Sponsor: Genentech

Principal Investigator: prof. dr. Siddhartha Lieten

Status: Completed