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ABBV-3373

Phase 2

Rheumatoid Arthritis (RA) | Small molecule | Immunology |AbbVie Inc.|Last Updated: Jul 19, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-3373 · 1 trial · 1 indication

Phase 2 1
NCT03823391A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)Rheumatoid Arthritis (RA)
COMPLETED48 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Rheumatoid Arthritis (RA)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])
Baseline and Week 12

The DAS28 (CRP) is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (measured on a visual analog scale \[VAS\] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.

Secondary Endpoints

Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
Baseline and Week 12
Change From Baseline in Simplified Disease Activity Index (SDAI)
Baseline and Week 12
Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
Baseline and Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABBV-3373 Followed by PlaceboEXPERIMENTALParticipants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22.
AdalimumabEXPERIMENTALParticipants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22.

Interventions

NameTypeDescription
ABBV-3373DRUGABBV-3373 is administered as intravenous (IV) infusion
Placebo for ABBV-3373DRUGPlacebo for ABBV-3373 is administered as IV infusion
AdalimumabDRUGAdalimumab is administered as subcutaneous (SC) injection
Placebo for adalimumabDRUGPlacebo for adalimumab is administered as subcutaneous (SC) injection
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites30

Inclusion Criteria: * Participant has the clinical diagnosis of RA for \> 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria. * Participant meets the following disease activity criteria: \>= 4 swo...

Countries:United StatesGermanyHungaryIsraelNetherlandsPolandPuerto Rico
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Frequently asked questions about ABBV-3373

What is ABBV-3373 used for?

ABBV-3373 is an investigational small molecule being developed for the treatment of moderate to severe rheumatoid arthritis (RA). It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes ABBV-3373?

ABBV-3373 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and efficacy in rheumatoid arthritis.

What phase is ABBV-3373 in?

ABBV-3373 is in Phase 2 clinical development for rheumatoid arthritis. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied in clinical trials to assess its safety and effectiveness.

What clinical trials is ABBV-3373 in?

ABBV-3373 has been studied in a completed Phase 2 clinical trial identified as NCT03823391. This randomized, double-blind, controlled study enrolled 48 participants with moderate to severe rheumatoid arthritis and evaluated the drug's safety, tolerability, pharmacokinetics, and efficacy.

How does ABBV-3373 work?

ABBV-3373 is a small molecule therapeutic, but its specific molecular target has not been disclosed. The drug is being investigated for its ability to treat rheumatoid arthritis, an autoimmune condition characterized by chronic joint inflammation.