Phase 2
N=78
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03664232 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour) — -0.20; -0.26 Score on a scale — p==0.284
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-42165279 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Day 85 in the Autism Behavior Inventory (ABI) Core Domain Score (Social Communication and Restrictive Behaviour) |
-0.20; -0.26 | =0.284 |
| PRIMARY Change From Baseline to Day 85 in the ABI Social Communication Domain Score |
-0.22; -0.27 | =0.290 |
| PRIMARY Change From Baseline to Day 85 in the ABI Repetitive/Restrictive Behavior (RRB) Domain Score |
-0.17; -0.23 | =0.231 |
| PRIMARY Change From Baseline to Day 85 in the Social Responsiveness Scale 2 (SRS-2) Total T-Score |
-6.4; -4.6; -4.1; -7.1 | — |
| SECONDARY Change From Baseline to Day 85 in the ABI Mood and Anxiety Domain Score |
-0.30; -0.23; -0.19; -0.26 | — |
| SECONDARY Change From Baseline to Day 85 in the ABI Challenging Behavior Domain Score |
-0.27; -0.22; -0.20; -0.20 | — |
| SECONDARY Change From Baseline to Day 85 in the ABI Self-Regulation Domain Score |
-0.31; -0.20; -0.11; -0.18 | — |
| SECONDARY Change From Baseline to Day 85 in the Aberrant Behavior Checklist (ABC) Subscales Scores |
-5.86; -3.80; -2.71; -4.18; -6.86; -3.31 | — |
| SECONDARY Change From Baseline to Day 71 in the Autism Behavior Inventory-Short Form (ABI-S) Domains Scores |
0.07; -0.17; -0.33; -0.32; -0.48; -0.24 | — |
| SECONDARY Change From Baseline to Day 85 in the Autism Behavior Inventory-Clinician Interview (ABI-C) Domains Scores |
-0.64; -0.26; -0.07; -0.40; -0.36; -0.44 | — |
| SECONDARY Change From Baseline to Day 85 in the Clinical Global Impression-Severity (CGI-S) Scale Score |
0.0; 0.0 | — |
| SECONDARY Change From Baseline to Day 85 in the Repetitive Behavior Scale - Revised (RBS-R) Subscale Score |
-1.6; -0.6; -1.0; -0.8; -1.4; 0.2 | — |
| SECONDARY Change From Baseline to Day 85 in the Zarit Burden Interview (ZBI) Global Score |
-2.0; -2.2; -4.3; -3.9 | — |
| SECONDARY Change From Baseline to Day 85 in the Child Adolescent Symptom Inventory - Anxiety (CASI-Anx) Scale Score |
-5.14; -4.89; -1.86; -5.19 | — |
| SECONDARY Change From Baseline to Day 85 in the Caregiver Global Impression of Severity (Caregiver GI-S) Scale Score |
0.0; 0.0 | — |
| SECONDARY Caregiver Assessment of Treatment: Question 1: Number of Participants With Overall Status (Improvement) of Autism at Day 85 |
0; 2; 0; 3; 2; 3 | — |
| SECONDARY Caregiver Assessment of Treatment: Question 2: Number of Participants With Improvement in Specific Symptoms During Treatment at Day 85 |
4; 16; 4; 12; 3; 13 | — |
| SECONDARY Caregiver Assessment of Treatment: Question 3: Number of Participants With Interest in Continuing Treatment at Day 85 |
2; 10; 0; 6; 1; 3 | — |
| SECONDARY Self Global Impression of Improvement (Self GI-I) Scale Score at Day 85 |
3.03; 3.41 | — |
| SECONDARY Clinical Global Impression-Improvement (CGI-I) Score (Frequency Distribution) at Day 85 |
0; 0; 0; 0; 0; 3 | — |
Summary
The purpose of this study is to evaluate the efficacy of JNJ-42165279 compared with placebo in the improvement of symptoms of Autism Spectrum Disorder (ASD) during 12 weeks of treatment using the Autism Behavior Inventory (ABI).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Autism Spectrum Disorder (ASD) according to Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and made or confirmed using the Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) (minimum score of 8 [autism spectrum])
- Otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests
- Have a composite score on Kaufman Brief Intelligence Test, Second Edition (KBIT-2) of at least 60
- Must live with a parent or primary caregiver or, if not, during each week he/she must either (A) spend at least 3 hours a day for at least 4 days or, (B) spend the weekend with a parent or primary caregiver
- Any pharmacologic, diet, or behavioral intervention for ASD must have begun at least 1 month prior to the baseline visit and continue unchanged through the treatment period, or have ended at least 1 month prior to the baseline visit
- Must be able to swallow the study medication whole and self-administer medication if living independently or have a parent or caregiver be able to administer medication
- Must agree to abide by the birth control requirements during the study and for 3 months after the last dose
Exclusion Criteria
- Current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
- Use of a drug with moderate/strong cytochrome P450 (CYP)3A4 inhibiting or inducing properties at, or prior to, screening that is not discontinued at least within 1 month prior to Day 1
- History of drug or alcohol use disorder according to DSM-5 criteria within 6 months before screening or positive test result(s) for alcohol or drugs of abuse (except if related to current treatment)
- Currently taking or has taken within the past month recreational or medically prescribed cannabis
Data sourced from ClinicalTrials.gov (NCT03664232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.