RO7017773 for Autism Spectrum Disorder

Recruiting at 36 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

104 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called RO7017773 to see if it can help people aged 15-45 with Autism Spectrum Disorder (ASD) who have a certain level of intelligence. The study will check how well the drug works, how safe it is, and how the body handles it.

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.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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