RO7017773 for Autism Spectrum Disorder

No longer recruiting at 38 trial locations

Overseen By Reference Study ID Number: BP41316 https://forpatients.roche.com/

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: Herbal remedies

Disqualifiers: Non-verbal, Substance abuse, Epilepsy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of a new treatment called RO7017773 for people with Autism Spectrum Disorder (ASD). Participants will receive either a placebo (a non-active substance), a low dose, or a high dose of RO7017773 to assess its impact on their condition. The trial seeks individuals diagnosed with ASD who have a certain level of cognitive function and face daily challenges related to autism. The study aims to determine if this new treatment can improve symptoms and daily life for those living with ASD. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that your current treatment regimens be stable for 8 weeks before screening and remain stable during the study. If you are taking any prohibited medications or herbal remedies, you must stop them at least 6 weeks before randomization.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that RO7017773 is being tested for safety in people with autism spectrum disorder (ASD). Previous studies found the treatment generally well-tolerated by patients, with serious side effects being rare. Common side effects included mild headaches and nausea, but these were not serious. As this study is in a mid-stage phase, researchers continue to learn about its safety. Some information exists on how people respond to the treatment, but more data is needed to fully understand its safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Researchers are excited about RO7017773 for Autism Spectrum Disorder because it works differently than most current treatments. While existing medications often target symptoms like irritability with antipsychotics or stimulants, RO7017773 is designed to address core social and communication challenges by modulating the glutamatergic system, which is thought to be involved in autism. This unique mechanism of action could offer a new way to improve social interactions and communication skills in people with autism, potentially providing benefits that existing options don't fully address.

What evidence suggests that RO7017773 might be an effective treatment for Autism Spectrum Disorder?

Research has shown that RO7017773 is under study as a potential treatment for managing symptoms of Autism Spectrum Disorder (ASD). This trial will test different doses of RO7017773, with participants receiving either a low or high dose, to determine the most effective and safest option. Early results suggest that RO7017773 might improve social behavior and reduce repetitive actions in people with ASD. While the effectiveness is still under investigation, the treatment aims to offer new options for individuals with ASD by addressing some core symptoms. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for individuals aged 15-45 with Autism Spectrum Disorder (ASD), who score at least 50 on the WASI-II intelligence test, have a BMI of 18.5 to 40 kg/m2, and experience autism symptoms. Participants must have a supportive caretaker and be able to follow study procedures without undue risk.

Inclusion Criteria

I know my height in inches.

Your body mass index (BMI) falls within the range of 18.5 to 40 kg/m2.

You have trouble making eye contact or other symptoms associated with autism.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or a fixed dose of RO7017773 for approximately 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RO7017773

Trial Overview The trial tests RO7017773's effectiveness and safety compared to a placebo over 12 weeks in treating ASD. It will also look into how the body processes the drug.

How Is the Trial Designed?

Group I: RO7017773 Low Dose Experimental Treatment 1 Intervention

Participants will receive a fixed low dose of RO7017773 for approximately 12 weeks.

Group II: RO7017773 High Dose Experimental Treatment 1 Intervention

Participants will receive a fixed high dose of RO7017773 for approximately 12 weeks.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to RO7017773 for approximately 12 weeks.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04299464

NCT04299464 | A 12-Week Placebo-Controlled Study to ... This study will investigate the efficacy, safety, tolerability, and pharmacokinetics of RO7017773 in participants aged 15-45 years who have been diagnosed ...

2. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/neurodevelopmental-disorder/autism/a-12-week-placebo-controlled-study-to-investigate-the-e-88629.html

Clinical Trial – Autism Spectrum Disorder – Safety and Ef... Access the clinical trial testing the safety, tolerability and efficacy of RO7017773 in patients aged 15-45 years with autism spectrum disorder.

3. forpatients.roche.com forpatients.roche.com/content/patient-platform/global/en/trials/neurodevelopmental-disorder/autism/a-12-week-placebo-controlled-study-to-investigate-the-e-88629.pdf

A clinical trial to compare different doses of an investigational ... Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged. 15-45 Years With Autism Spectrum Disorder (ASD). Trial ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/64/NCT04299464/Prot_000.pdf

A Phase II Multicenter, Randomized, Double-Blind, 12-Week The objectives of this Phase 2 proof-of-concept study (BP41316) are to investigate the efficacy, safety, and tolerability of RO7017773 in adolescents and adults ...

5. withpower.com withpower.com/trial/phase-3-child-development-disorders-pervasive-2-2021-4c43f

RO7017773 for Autism Spectrum Disorder Trial Overview The trial tests RO7017773's effectiveness and safety compared to a placebo over 12 weeks in treating ASD. It will also look into how the body ...

6. app.trialscreen.org app.trialscreen.org/trials/phase-2-autism-spectrum-disorder-asd-12-week-placebo-controlled-to-investigate-trial-nct04299464

A 12-Week Placebo-Controlled Study to Investigate ... This study aims to examine how RO7017773 can treat Autism Spectrum Disorder in those aged 15-45 with a score of >/=50 on the Wechsler ...