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Benlysta

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

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

Benlysta · 1 trial · 1 indication

Phase 1 1
NCT04611971A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2Healthy
COMPLETED13 Analytics
PHASE1COMPLETED
A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2
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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 8

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 2 months
Number of Participants with Treatment-Emergent Serious Adverse Events (SAEs) in the Active Arm Versus the Control Arm
Up to 2 months
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 2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Active Arm: Benlysta + CandinACTIVE_COMPARATORParticipants will receive a single dose of Candin injection intradermally along with a saline solution of 0.9% sodium chloride (NaCl), and a single dose of Benlysta injection subcutaneously.
Control Arm: CandinNO_INTERVENTIONAll participants will receive a single dose of Candin injection intradermally along with a single dose of saline solution of 0.9% NaCl administered intradermally and no Benlysta.

Interventions

NameTypeDescription
BenlystaDRUGBenlysta injection will be administered subcutaneously.
CandinDRUGCandin will be administered intradermally along with NaCl solution.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2, inclusive (BMI = weight/height\^2), and 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 Benlysta

What is Benlysta?

Benlysta is an investigational small molecule 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 Benlysta used for?

Benlysta is being studied for use in healthy participants. It is currently in Phase 1 clinical development, and the specific condition it is intended to treat has not been established. The drug is being evaluated in a clinical trial involving healthy volunteers.

Who makes Benlysta?

Benlysta is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development.

What phase is Benlysta in?

Benlysta is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a clinical trial involving healthy participants.

What clinical trials is Benlysta in?

Benlysta is associated with one completed clinical trial, NCT04611971, titled "A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 2." This Phase 1 trial enrolled 13 participants in Belgium and was active-controlled.