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Tofacitinib

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Feb 3, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Tofacitinib · 1 trial · 1 indication

Phase 1 1
NCT04985955A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3Healthy
COMPLETED12 Analytics
PHASE1COMPLETED
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3
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Study Endpoints

Primary Endpoints

Number of Participants with Presence and Size of Induration in Active Versus Control at the Candin Injection Site Compared to the Intra-individual Saline Control Injection Site Approximately 48 Hours After Candin Challenge
Day 5

Number of participants with presence and size of induration in active versus control at the Candin injection site compared to the intra-individual saline control injection site approximately 48 hours after Candin challenge will be reported.

Secondary Endpoints

Number of Participants with Treatment-emergent Adverse Events (TEAEs) in the Active Arm Versus the Control Arm
Up to 6 weeks
Number of Participants with Treatment-emergent Serious Adverse Events (SAEs) in the Active Arm Versus the Control Arm
Up to 6 weeks
Number of Participants with TEAEs by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) with a Frequency Threshold of 5 Percent (%) or More in the Active Arm Versus the Control Arm
Up to 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Candin + TofacitinibEXPERIMENTALParticipants will receive a single dose of Candin injection on forearm of 1 arm along with a saline solution injection of 0.9 percent (%) sodium chloride (NaCl) on the opposite forearm on Day 3 and oral dose of tofacitinib for 5 days.
Candin ChallengeNO_INTERVENTIONAll participants will receive a single dose of Candin injection on forearm of 1 arm along with a saline solution injection of 0.9% NaCl on the opposite forearm on Day 3.

Interventions

NameTypeDescription
TofacitinibDRUGTofacitinib tablet will be administered orally.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of no less than 50 kilograms (kg) * Healthy on the basis of physical examination, medical history, and vital signs performed at screening....

Countries:Belgium
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Frequently asked questions about Tofacitinib

What is Tofacitinib?

Tofacitinib is a small molecule drug being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug is being studied in healthy participants, and its therapeutic area is classified as Other.

What is Tofacitinib used for?

Tofacitinib is being studied for use in healthy participants. It is currently in Phase 1 clinical development, with one completed trial involving 12 participants. The drug is not yet approved and is still in the investigational stage.

Who makes Tofacitinib?

Tofacitinib is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting clinical trials to evaluate the drug in healthy participants.

What phase is Tofacitinib in?

Tofacitinib is in Phase 1 clinical development. It is an investigational drug and has not been approved. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is Tofacitinib in?

Tofacitinib has one completed clinical trial, NCT04985955, titled "A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3." This Phase 1 trial enrolled 12 participants in Belgium and was not double-blinded.

Is Tofacitinib the same as any other drug?

Tofacitinib is the drug name provided in the data. No alternative names have been listed for this drug in the available information.