Update: RG6042 Phase III GENERATION HD1 study re-opens
Dear global patient community partners,
Following your previous request to be kept up to date on the clinical development programme for RG6042 for Huntington’s disease, we would like to provide an update on the status of the Phase III GENERATION HD1 study (ClinicalTrials.gov ID: NCT03761849), including participating countries in Asia-Pacific, Europe, North America and South America.
The purpose of the Phase III study is to evaluate the efficacy and safety of RG6042 treatment for manifest Huntington’s disease. In March we announced our plan to amend the dosing frequency and study design in a way that makes study participation less demanding for patients, their families and HD centres. Since then, our team has been working to implement study changes and obtain approvals from clinical trial review boards and authorities around the world.
“Today I am pleased to share that we have re-opened the study for recruitment of new patients. Initial clinical trial authorisations to start the amended GENERATION HD1 study have been received, and we expect to receive the remaining approvals soon. Recruitment timing will be different at each participating HD clinic/centre, because the protocol amendment must be fully approved and in place at each study site before local recruitment may open. Our team is working to rapidly activate the updated study protocol at each site” writes Mai-Lise Nguyen.
Participant eligibility and enrolment are determined by the study investigator at each site. Some sites may enrol patients with an established history with their centre, before recruiting new patients. Anyone interested in participating in clinical research should first discuss with his/her HD specialist about what may be best for his/her situation.
The GENERATION HD1 study will run at more than 90 sites around the world. Below I have listed the 18 countries in which these clinical trial sites are located. In the next days, individual site information will be updated on ClinicalTrials.gov and our global ForPatients.Roche.com website.
The HD community has had a keen interest in our research efforts. We are extremely grateful for the ongoing support, and we are committed to completing the study as quickly as possible to provide data to health authorities.
The Roche Medical/Clinical Trial Information teams can be contacted for more information about the study/sites via Medinfo.Roche.com. Additionally, country-specific contact information is below.
Australia (firstname.lastname@example.org, +61 1800 233 950)
Japan (study is run under Chugai Pharmaceutical, a member of the Roche group, who can be directly contacted using this link)
New Zealand (email@example.com, +64 0800 276 243)
Denmark (firstname.lastname@example.org, +45 3639 9999)
Germany (email@example.com, +49 07624-14-2015)
The Netherlands (firstname.lastname@example.org)
United Kingdom (email@example.com, +44 0800 3281629)
Canada (firstname.lastname@example.org, +1-888-762-4388)
USA (study is run under Genentech, a member of the Roche group, who can be contacted via +1-888-662-6728)
About the Phase III GENERATION HD1 study design
The GENERATION HD1 study will evaluate the efficacy and safety of RG6042 treatment given once every two months (every eight weeks) or every four months (every 16 weeks) over a period of 25 months. This amended global study will enroll up to 660 patients with manifest HD at more than 90 sites around the world.
GENERATION HD1 is designed to determine the efficacy and safety of RG6042, and therefore includes a comparison to placebo. Participants will be randomised to one of three study arms: 120mg RG6042 every eight weeks, 120mg RG6042 every 16 weeks or placebo every eight weeks. This means for every two participants randomised to RG6042 treatment, only one will receive the placebo. The study is “double-blinded,” meaning neither the participant nor his/her investigator or site staff will know which study arm the participant is assigned.
For all patients who complete the GENERATION HD1 study, the option of participation in an open-label extension study (GEN-EXTEND) evaluating RG6042 (no placebo control) is planned, pending eligibility, approval by local Authorities and Ethics Committees/Institutional Review Boards and if data support the continued development of RG6042.