RO7017773 for Pervasive Development Disorders

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pervasive Development Disorders+4 More
RO7017773 - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study if a new drug is effective, safe, and well tolerated in people with ASD aged 15-45 years.

Eligible Conditions
  • Pervasive Development Disorders
  • Autoimmune Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Days 14, 42, 84, 98, 126

Day 14
Change from Baseline Over Time in Suicide Risk Using the Columbia-Suicide-Severity Rating Scale (C-SSRS)
Week 12
Percentage of Participants Discontinuing Treatment due to AEs
Up to Week 18
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Serious Adverse Events (SAEs)
Week 12
Change from Baseline to Week 12 in Behavior/Symptoms as Measured by all Domains of the Repetitive Behavior Scale-Revised (RBS-R)
Change from Baseline to Week 12 in the Adaptive Behavior Composite score of the Vineland Adaptive Behavior Scales, Third Edition (Vineland-3)
Change from Baseline to Week 12 on the Vineland-3 Socialization Domain
Change from baseline to Week 12 on the Vineland-3 Communication domains

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

RO7017773 - 75mg
50%Back pain
This histogram enumerates side effects from a completed 2018 Phase 1 trial (NCT03507569) in the RO7017773 - 75mg ARM group. Side effects include: Back pain with 50%.

Trial Design

3 Treatment Groups

RO7017773 Low Dose
1 of 3
RO7017773 High Dose
1 of 3
Placebo
1 of 3

Experimental Treatment

Non-Treatment Group

105 Total Participants · 3 Treatment Groups

Primary Treatment: RO7017773 · Has Placebo Group · Phase 2

RO7017773 Low Dose
Drug
Experimental Group · 1 Intervention: RO7017773 · Intervention Types: Drug
RO7017773 High Dose
Drug
Experimental Group · 1 Intervention: RO7017773 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7017773
2018
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 14, 42, 84, 98, 126

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,352 Previous Clinical Trials
1,093,947 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,134 Previous Clinical Trials
901,441 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
How tall are you in inches?
How much do you weigh, in pounds?
The text discusses male and female participants who have Autism Spectrum Disorder as classified by the DSM-5.
Have you been diagnosed with autism by an expert (physician or psychologist)?
Do you frequently experience autism symptoms (ex: difficulty maintaining eye contact)?
Do you have a caretaker who is willing to support your participation in the study?
Do you have a caretaker who is willing to support your participation in the study?
to the subject It is the Investigator's opinion that participating in this study or discontinuing prohibited medication will not pose any undue risks to the subject.
In the Investigator's opinion, the study participant is capable of participating and deemed appropriate for participation in the study, capable of following the study SoA and able to comply with the study restrictions.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York35.7%
Illinois17.9%
Arizona17.9%
Other28.6%
How old are they?
< 1850.0%
18 - 6546.4%
65+3.6%
What site did they apply to?
Southwest Autism Research & Resource Center36.8%
Montefiore Medical Center21.1%
A.O.U. Policlinico - V. Emanuele - P.O. Gaspare Rodolico; Dip. Terapia integrata disturbi resistenti15.8%
Other26.3%
What portion of applicants met pre-screening criteria?
Met criteria67.9%
Did not meet criteria32.1%