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NCT03464136COMPLETEDanonymous

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

Sponsor

Source record

Janssen Scientific Affairs, LLC

Phase

Source record

PHASE3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Indication / condition

AI-normalized

Crohn Disease

Intervention

Source record

Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Source & freshness

Source record

NCT ID

NCT03464136

Original source

ClinicalTrials.gov

Source last updated

Apr 29, 2025

Ingested at

Jun 09, 2026

Internal sync

Jun 09, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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View original source fields

NCT ID

NCT03464136

Title

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

Sponsor

Janssen Scientific Affairs, LLC

Status

COMPLETED

Phase

PHASE3

Condition raw

Crohn Disease

Condition normalized

Crohn Disease

Modality raw

monoclonal antibody

Modality normalized

monoclonal antibody

Target raw

Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Target normalized

Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Interventions

Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Public preview

Source record

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT03464136

Status

COMPLETED

Phase

PHASE3

Sponsor

Janssen Scientific Affairs, LLC

Executive brief

Investment-Ready Snapshot

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedApr 29, 2025
Internal syncJun 09, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT03464136

Indication

Crohn Disease

Modality

monoclonal antibody

Target

Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Intervention

Placebo for Ustekinumab, Placebo for Adalimumab, Ustekinumab (6 mg/kg), Ustekinumab (90 mg), Adalimumab (40 mg)

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.