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ABBV-257

Phase 1

Rheumatoid Arthritis | Monoclonal antibody | Immunology |AbbVie Inc.|Last Updated: Mar 3, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-257 · 1 trial · 1 indication

Phase 1 1
NCT02531178A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED8 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects with adverse events
Up to day 193

This will be collected through out the study

Change in Vital signs
From day 1 to day 193

Vital signs including blood pressure and heart rate will be assessed

Change in Physical examination
From day 1 to day 193

Changes in any physical exam assessed by the physician will be assessed.

Changes in Electrocardiogram (ECG)
From day 1 to day 193

ECG measurements will be assessed

Maximum observed serum concentration (Cmax)
Up to day 50

This will be assessed using non-compartmental methods.

Time to maximum observed serum concentration (Tmax)
Up to day 50

This will be assessed using non-compartmental methods.

Secondary Endpoints

Immunogenicity by measurement of Anti-drug antibody
Up to day 193
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
low dose ABBV-257EXPERIMENTALLow dose every other week (eow), Weeks 0-8
Medium dose of ABBV-257EXPERIMENTALMedium dose every other week (eow), Weeks 0-8
high dose of ABBV-257EXPERIMENTALhigh dose every other week (eow), Weeks 0-8

Interventions

NameTypeDescription
ABBV-257BIOLOGICALsubcutaneous injection
PlaceboBIOLOGICALPlacebo for ABBV-257
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis based on the 2010 American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) criteria, or ACR 1987 for patients with diagnosis prior 2011 ≥ 3 months. * Except for methotrexate (MTX), the subject must have discontinued al...

Countries:Germany
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Frequently asked questions about ABBV-257

What is ABBV-257 used for in rheumatoid arthritis?

ABBV-257 is an investigational monoclonal antibody being developed for the treatment of rheumatoid arthritis. It is administered by subcutaneous injection and is currently in Phase 1 clinical development. The drug is not approved and remains under study to assess its safety, tolerability, and pharmacokinetics in patients with rheumatoid arthritis.

What does ABBV-257 target?

ABBV-257 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its potential role in treating rheumatoid arthritis, an autoimmune condition, though the precise mechanism of action is not publicly detailed.

Who makes ABBV-257?

ABBV-257 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. AbbVie is conducting clinical research on this investigational monoclonal antibody for rheumatoid arthritis.

What phase is ABBV-257 in?

ABBV-257 is in Phase 1 clinical development. A Phase 1 study has been completed, evaluating the safety, tolerability, and pharmacokinetics of multiple subcutaneous injections in subjects with rheumatoid arthritis. The drug is investigational and has not received regulatory approval.

What clinical trials is ABBV-257 in?

ABBV-257 has one completed clinical trial, identified as NCT02531178. This Phase 1 study assessed the safety, tolerability, and pharmacokinetics of multiple subcutaneous injections of ABBV-257 in 8 participants with rheumatoid arthritis. The trial was randomized, double-blind, and controlled, conducted in Germany.

Is ABBV-257 the same as any other drug?

ABBV-257 is a unique investigational drug candidate developed by AbbVie. No alternative names or brand names have been associated with this compound in available information. It is distinct from other AbbVie products and is being studied specifically for rheumatoid arthritis.