A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder (Envision)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: JNJ-42165279; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03664232

42165279AUT2001 (Other Identifier)

CR108275

Details and patient eligibility

About

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).

Enrollment: 78 patients

Sex: All

Ages: 13 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups, including a placebo group

JNJ-42165279

Experimental group

Description:

Participants will self-administer 25 milligram (mg) JNJ-42165279 tablets orally twice daily for 12 weeks.

Treatment:

Drug: JNJ-42165279

Placebo

Placebo Comparator group

Description:

Participants will self-administer matching placebo tablets orally twice daily for 12 weeks.

Treatment:

Drug: Placebo