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JADE201

Phase 1

Rhematoid Arthritis | Small molecule | Immunology |Jade Biosciences, Inc.|Last Updated: Jun 1, 2026

Target and mechanism

Molecular targetBAFF-R
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

JADE201 · 1 trial · 1 indication

Phase 1 1
NCT07533955A Phase 1 Study of JADE201 in Participants With Rheumatoid ArthritisRhematoid Arthritis
RECRUITING36 Analytics
PHASE1RECRUITING
A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis
Rhematoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis
Day 1 through 36 weeks

Incidence of treatment-emergent adverse events

Secondary Endpoints

Cmax
Day 1 through Weeek 36
Tmax
Day 1 through Week 36
AUClast
Day 1 through Week 36
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
JADE201EXPERIMENTALSubcutaneous (SC) injection of JADE201
PlaceboEXPERIMENTALSubcutaneous (SC) injection of Placebo

Interventions

NameTypeDescription
JADE201DRUGJADE201 is supplied as sterile solution to be administered by SC injection.
PlaceboDRUGPlacebo solution to be administered at a matching volume by SC injection.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Male and female participants 18-70 years of age, inclusive. 2. A body weight between 50-100 kg and a body mass index (BMI) between 18-32 kg/m2 (all inclusive) at screening. 3. Confirmed diagnosis of RA according to 2010 ACR/EULAR criteria 4. Willing and able to comply with th...

Countries:MoldovaUkraine
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Frequently asked questions about JADE201

What is JADE201 used for in rheumatoid arthritis?

JADE201 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development, with an ongoing study evaluating its safety and efficacy in participants with this condition.

What does JADE201 target?

JADE201 targets BAFF-R, a protein involved in the immune system. By targeting BAFF-R, JADE201 aims to modulate immune responses relevant to rheumatoid arthritis. This mechanism is being investigated in a Phase 1 clinical trial.

Who is developing JADE201?

JADE201 is being developed by Jade Biosciences, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug in participants with rheumatoid arthritis.

What phase is JADE201 in?

JADE201 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 1 study is currently recruiting participants with rheumatoid arthritis to assess its safety and tolerability.

What clinical trials is JADE201 in?

JADE201 is being studied in a Phase 1 clinical trial with the identifier NCT07533955. This randomized, double-blind, controlled study is recruiting 36 participants with rheumatoid arthritis in Moldova and Ukraine. The trial is currently active and recruiting.

Is JADE201 the same as any other drug?

No alternative names for JADE201 have been disclosed. It is a distinct investigational small molecule developed by Jade Biosciences, Inc. for rheumatoid arthritis, and it is not known to be identical to any other approved or investigational drug.