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DKB903

Phase 1

Rheumatoid Arthritis and Systemic Lupus Erythematosus | Small Molecules | Immunology |Novartis AG|Trials Updated: Nov 6, 2026

DKB903 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

DKB903 clinical trials

DKB903 · 1 trial · 1 indication

Phase 1 1
NCT07923747An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis and Systemic Lupus Erythematosus
NOT YET_RECRUITING90 Analytics
PHASE1NOT YET_RECRUITING
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Day 1 up to approximately 2 years.

Number of participants with AEs and SAEs, including changes in vital signs, electrocardiograms (ECGs) and laboratory values qualifying and reported as AEs.

Secondary Endpoints

Presence/absence of anti-drug antibodies (ADA) at baseline and over time
Baseline, up to approximately 2 years.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A- Cohort A-DKB903EXPERIMENTALParticipants will receive DKB903 at escalating dose levels.
Part B- Cohort B-DKB903 dose level identified as safe in Part AEXPERIMENTALDKB903 dose level identified as safe in Part A, plus up to two additional full doses.

Interventions

NameTypeDescription
DKB903DRUGDKB903
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Able to communicate well with the Investigator, to understand the study and willing to comply with the requirements of the study. * Immunization (primary or from vaccinations) against pneumococ...

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Recent Changes (Last 90 Days)

LOWNov 6, 2026NCT07923747NEW_TRIAL: changed
LOWNov 6, 2026NCT07923747NEW_TRIAL: changed