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JNJ-64251330

Phase 1

Adenomatous Polyposis Coli | Small molecule | Gastrointestinal |Johnson & Johnson|Trials Updated: Jun 2, 2023

JNJ-64251330 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Sep 2020

JNJ-64251330 target and mechanism

ModalitySmall molecule

Also known as Lorpucitinib

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

JNJ-64251330 clinical trials

JNJ-64251330 · 1 trial · 1 indication

Phase 1 1
NCT05014360A Study of JNJ-64251330 in Participants With Familial Adenomatous PolyposisAdenomatous Polyposis Coli
COMPLETED42 Analytics
PHASE1COMPLETED
A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis
Adenomatous Polyposis ColiUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage Change from Baseline in Colorectal Polyp Burden for all Polyps at Week 24
Baseline and Week 24

Percentage change from baseline in colorectal polyp burden for all polyps (the sum of the polyp diameters) at Week 24 will be reported.

Percentage Change from Baseline in Colorectal Polyp Burden for Polyps >=2 mm at Week 24
Baseline and Week 24

Percentage change from baseline in colorectal polyp burden (sum of the polyp diameters) for polyps greater than or equal to (\>=) 2 millimeters (mm) at Week 24 will be reported.

Secondary Endpoints

Percentage Change in Number of Colon Polyps
Baseline and Week 24
Percentage Change in Number of Rectal Polyps
Baseline and Week 24
Percentage Change in Number of J-pouch Polyps
Baseline and Week 24
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-64251330EXPERIMENTALParticipants will receive oral dose of JNJ-64251330 twice daily for 24 Weeks.

Interventions

NameTypeDescription
JNJ-64251330DRUGJNJ-64251330 tablets will be administered orally.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Genetic diagnosis of classical familial adenomatous polyposis (FAP) (adenomatous polyposis coli \[APC\] germline mutation or obligate carrier) with disease involvement of the colorectum * At least 6 polyps greater than or equal to (\>=) 2 millimeters (mm) in diameter in the re...

Countries:United StatesFranceGermanyNetherlandsPuerto RicoSouth KoreaSpain
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Frequently asked questions about JNJ-64251330

What is JNJ-64251330?

JNJ-64251330 is an investigational small molecule developed by Johnson & Johnson for Adenomatous Polyposis Coli, a gastrointestinal condition. It has completed a Phase 1 clinical trial and is not yet approved for any indication.

What is JNJ-64251330 used for?

JNJ-64251330 is being studied for the treatment of Adenomatous Polyposis Coli, a gastrointestinal condition characterized by multiple adenomas in the colon and rectum. It is investigational and has not been approved for any use.

Who is developing JNJ-64251330?

JNJ-64251330 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company is responsible for the clinical development of this small molecule for Adenomatous Polyposis Coli.

What phase is JNJ-64251330 in?

JNJ-64251330 has completed a Phase 1 clinical trial. It remains an investigational drug and has not received FDA approval. No later-phase trials are currently active.

What clinical trials is JNJ-64251330 in?

JNJ-64251330 was evaluated in a Phase 1 trial, NCT05014360, titled A Study of JNJ-64251330 in Participants With Familial Adenomatous Polyposis. The trial enrolled 42 participants across the United States, France, Germany, Netherlands, Puerto Rico, South Korea, and Spain, and is now completed.