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SUNFISH & JEWELFISH trials for SMA Type 2 & 3

What is the purpose of our SUNFISH & JEWELFISH clinical trials?

We aim to learn whether an investigational medicine called RG7916 (also known as RO7034067) is safe and effective in people with Type 2 and Type 3 SMA.

The investigational treatment is taken once daily in liquid form by mouth or feeding tube.

The SUNFISH clinical trial examines our investigational medicine for an age group between 2 to 25 years.

Another clinical trial, JEWELFISH is for people who have previously participated in an SMA patient study with SMN2 targeting therapies RG7800 or nusinersen. For more information about JEWELFISH, click here.

 

 

The SUNFISH clinical trial

The study doctor conducting the clinical trial must first assess whether a person is eligible to participate in a clinical trial. This assessment is based on specific medical grounds.

The SUNFISH trial has two parts

Part 1 will allow us to determine the most appropriate dose of RG7916 to be further investigated in Part 2. Part 1 includes a small number of people, so it will take place at study sites in a few countries.
Part 2 will assess safety and efficacy of RG7916 at the dose selected in Part 1. As Part 2 includes a much larger number of people, more sites and countries will participate in Part 2.

How many people will be enrolled?

Part 1 will include approximately 36 people.
Part 2 will include approximately 168 *additional people.

How long is treatment given for?

Part 1: 12 weeks of treatment followed by an open-label extension phase. In the open-label extension, everyone receives RG7916.
Part 2: People receiving placebo will be switched to RG7916 after 12 months of treatment. After 24 months of treatment every patient will be offered to receive the study drug in an open label extension phase*.

Could I be given a placebo if I take part?

Yes, the SUNFISH trial is a randomised, double-blinded, placebo controlled trial, so you may be given placebo.
In Part 1 for every 2 people receiving RG7916, one person will receive placebo, i.e. the ratio is 2:1. Everyone who is receiving placebo in Part 1 will switch to RG7916 for the rest of the clinical trial, after approximately 12 weeks of treatment.

In Part 2, for every 2 people receiving RG7916, one person will receive placebo i.e. the ratio is 2:1*. Everyone who is receiving placebo in Part 2 will switch to RG7916 for the rest of the clinical trial, after they have completed 12 months of therapy*.

What are the eligibility criteria to take part?

1. Be between 2 and 25 years of age at enrollment
2. Genetically confirmed diagnosis of either SMA Type 2 or Type 3
3. Part 1: Type 2 or 3 SMA ambulant or non-ambulant
Part 2: Type 2 or 3 SMA non-ambulant (can’t walk more than 10 meters (32 feet) without assistance) but able to sit independently with revised upper limb module (RULM) entry item A greater than or equal to 2
4. Able to travel to the study site several times over a 2 year period
5. Not currently enrolled in another clinical trial
6. Have not received gene or cell therapy, SMN2 antisense oligonucleotide therapy or any SMN2
splicing modifier
7. Be able to follow study procedures
8. Be able to take a daily oral medication either by mouth or by feeding tube
9. No surgery for scoliosis or hip fixation within 1 year before screening or planned within the next 18 months
10. Have not had an eye disease within the past year
11. Be able to allow eye examinations to be performed
Please refer to www.clinicaltrials.gov for more inclusion and exclusion criteria.

I am interested in joining SUNFISH – what should I do?

Please contact your treating physician to discuss the clinical trial.

 

 
Your local patient group may also be able to provide you with additional information.
You can also contact us if you need more information.

Where is my nearest study centre?

Locate hospitals that are participating in the SUNFISH trial using our Find My Trial tool.

My country is not listed in www.clinicaltrials.gov and is not found using FIND MY TRIAL. How can I take part in SUNFISH?

Participating in a trial in another country will be at the discretion of the investigator and is decided on an individual basis.

We can put you in contact with people who can answer your questions about Roche clinical trials in another country.

You can also regularly check back at www.clinicaltrials.gov and Find My Trial for newly opened sites.

Who will pay the costs associated with participation?

Roche will cover the cost of study medication, visits, assessments and reasonable costs of travel.

When will Part 2 of SUNFISH begin?

We expect Part 2 of SUNFISH to begin in the second half of 2017.

* The updated study protocol is pending final approval from the regulatory authorities.

 

 

The JEWELFISH Trial

What is the purpose of our JEWELFISH clinical trial?

The study is for people who have previously participated in an SMA patient study with SMN2 targeting therapies RG7800 or nusinersen.

The JEWELFISH clinical trial examines our investigational medicine for an age group between 12 to 60 years of age.

The investigational treatment is taken once daily in liquid form by mouth or feeding tube.

 

 

How many patients will be enrolled?

The clinical trial will include approximately 24 patients.

How long is treatment given for?

The clinical trial runs for 24 months of treatment followed by 12 months follow up period, all patients will receive RG7916. There is no placebo in this clinical trial.

What are the eligibility criteria to take part?

1. Be between 12 and 60 years of age at enrollment
2. Be medically diagnosed with either SMA Type 2 or Type 3
3. Have previously participated in a clinical trial with a SMN2 targeting antisense oligonucleotide (e.g. nusinursen) or SMN2 splicing modifier other than RG7916.
4. Able to travel to the study site several times over a 2 year period
5. Not currently enrolled in another clinical trial
6. Have not received gene or cell therapy
7. Be able to follow study procedures
8. Be able to take a daily oral medication either by mouth or by feeding tube
9. Have not had an eye disease within the past year
10. Be able to allow eye examinations to be performed
Please refer to www.clinicaltrials.gov for more inclusion and exclusion criteria.

I am interested in joining JEWELFISH – what should I do?

Please contact your treating physician to discuss the clincal trial.

 

 

Your local patient group may also be able to provide you with additional information.
You can also contact us if you need more information.

Where is my nearest study centre?

Locate hospitals that are participating in the JEWELFISH trial using our Find My Trial tool.

My country is not listed in www.clinicaltrials.gov and is not found using FIND MY TRIAL. How can I take part in JEWELFISH?

Participating in a trial in another country will be at the discretion of the investigator and is decided on an individual basis.

We can put you in contact with people who can answer your questions about Roche clinical trials in another country.

You can also regularly check back at www.clinicaltrials.gov and Find My Trial for newly opened sites.

Could I be given a placebo if I take part?

No, the JEWELFISH trial is an open-label study, so all patients will be given RG7916.

Who will pay the costs associated with participation?

Roche will cover the cost of study medication, visits, assessments and reasonable costs of travel.

The OLEOS trial

What is the purpose of our OLEOS clinical trial?

The OLEOS trial assesses the long-term safety and effectiveness of Olesoxime in children and adults with Type 2 or 3 SMA who have previously taken part in another trial with Olesoxime.

Can I take part in the OLEOS trial?

The OLEOS trial has completed recruiting.