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RO7017773 · 2 trials · 2 indications
Vineland-3 is a semi-structured interview that measures an individual's adaptive behavior across 3 domains: Communication, Socialization, and Daily Living skills. Each domain is composed of 3 subdomains. Subdomain raw score is based on item responses (3-point scale: 0=never present; 1=sometimes present; 2=usually present) and is calculated for each subdomain of the three main domains as the sum of the scores for each item within the subdomain. Raw scores of the 9 subdomains are used to derive Growth Scale Values (GSVs; range = 10-197). A conversion table for mapping raw scores to GSV scores is found in Appendix 3, Table B.2 in the Vineland-3 manual (Sparrow et al. 2016). GSV is a person-ability score used to track an individual's progress. Vineland-3 ABC Composite GSV score is calculated as the mean GSV score (summing the 9 GSV subdomain scores and dividing by 9; Vineland-3 ABC Composite GSV scores can range from 10-154). A higher score indicates better adaptive functioning.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to RO7017773 for approximately 12 weeks. |
| RO7017773 Low Dose | EXPERIMENTAL | Participants will receive a fixed low dose of RO7017773 for approximately 12 weeks. |
| RO7017773 High Dose | EXPERIMENTAL | Participants will receive a fixed high dose of RO7017773 for approximately 12 weeks. |
| RO7017773 | EXPERIMENTAL | The first two participants of the first cohort are anticipated to receive a single dose of RO7017773 orally. The doses to be tested in the subsequent cohorts of participants will be determined by review of PET scan, PK, and safety results from the previous dose level. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Participants will receive oral placebo for approximately 12 weeks. |
| RO7017773 | DRUG | Participants will receive oral RO7017773 for approximately 12 weeks. |
| [11C] Ro15-4513 | OTHER | At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer \[11C\]Ro15-4513. |
Inclusion Criteria * Male and female participants with Autism Spectrum Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Wechsler Abbreviated Scale of Intelligence (WASI-II) \>/= 50 at screening or within the last 12 months prior to screening * ASD...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 3 | PHASE3 | Xanomeline and trospium chloride, KarX-EC |
| Definium Therapeutics, Inc. | DFTX | 1 | PHASE2 | DT402 |
| MapLight Therapeutics, Inc. | MPLT | 1 | PHASE2 | ML-004 |
RO7017773 is an investigational small molecule developed by Roche Holding AG for Autism Spectrum Disorder. It has been studied in two completed clinical trials, including a Phase 2 placebo-controlled study in participants aged 15 to 45 years. It is not an approved therapy and remains in clinical development.
RO7017773 was studied as a potential treatment for Autism Spectrum Disorder. The Phase 2 trial evaluated its efficacy, safety, and tolerability over 12 weeks in participants aged 15 to 45 years with ASD. No approved use exists; the compound is investigational.
RO7017773 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche sponsored both clinical trials of the compound, including the Phase 2 study in Autism Spectrum Disorder and a Phase 1 PET imaging study.
RO7017773 has completed Phase 2 testing. A 12-week placebo-controlled Phase 2 trial in Autism Spectrum Disorder is listed as completed, and an earlier Phase 1 PET study is also completed. The drug is investigational and has not been approved for any indication.
RO7017773 has been evaluated in two completed trials. NCT04299464 was a 12-week placebo-controlled Phase 2 study in Autism Spectrum Disorder with 104 participants across the United States, Canada, Italy, and Spain. NCT03507569 was a Phase 1 PET study with 6 participants in the United Kingdom.
Across the two completed trials, 110 participants were enrolled. The Phase 2 Autism Spectrum Disorder study, NCT04299464, enrolled 104 participants, and the Phase 1 PET study, NCT03507569, enrolled 6 participants. Both studies were randomized and double-blind where applicable.