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CDP7657

Phase 1

Immune System Diseases | Monoclonal antibody | Immunology |Biogen Inc.|Last Updated: Jul 16, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

CDP7657 · 1 trial · 5 indications

Phase 1 1
NCT01764594Safety Study of CDP7657 in Patients With Systemic Lupus ErythematosusImmune System Diseases
COMPLETED24 Analytics
PHASE1COMPLETED
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
Immune System DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study
0 - 28 Weeks
Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study
0 - 28 Weeks

Secondary Endpoints

Maximum plasma concentration (Cmax)
0 - 28 Weeks
Predose plasma concentration (Ctrough)
0 - 28 Weeks
Area under the concentration-time curve over the dosing interval (AUCτ)
0 - 28 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
CDP7657EXPERIMENTALCDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks
PlaceboPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
CDP7657BIOLOGICALCDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks
PlaceboOTHERPlacebo comparator
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Patients with Systemic Lupus Erythematosus (SLE) Exclusion Criteria: * Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (SLE) * History of chronic, recurrent, or recent severe infection * Significant hematologic abnormalities * History of cancer, heart fa...

Countries:BelgiumBulgariaGermanyPolandRomaniaRussiaSpain
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Frequently asked questions about CDP7657

What is CDP7657 used for?

CDP7657 is an investigational monoclonal antibody being studied for immune system diseases, specifically systemic lupus erythematosus. It is being developed by Biogen Inc. for the treatment of this autoimmune condition.

What does CDP7657 target?

CDP7657 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in modulating the immune system in systemic lupus erythematosus.

Who makes CDP7657?

CDP7657 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research on this investigational therapy for systemic lupus erythematosus.

What phase is CDP7657 in?

CDP7657 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under clinical investigation.

What clinical trials is CDP7657 in?

CDP7657 has been studied in one completed Phase 1 clinical trial, NCT01764594, which evaluated its safety in patients with systemic lupus erythematosus. The trial enrolled 24 participants across multiple countries in Europe.

Is CDP7657 the same as any other drug?

CDP7657 is the primary name for this investigational monoclonal antibody. No alternative names have been associated with this drug in the available information, so it is not known to be the same as any other marketed or investigational product.