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REGN668

Phase 1

Dermatitis | Monoclonal antibody | Dermatology |Regeneron Pharmaceuticals, Inc.|Last Updated: Jun 17, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

REGN668 · 2 trials · 2 indications

Phase 1 2
NCT01259323Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic DermatitisDermatitis
COMPLETED30 Analytics
NCT01015027Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy VolunteersHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis
DermatitisUnlock trial analytics
PHASE1COMPLETED
Ascending Dose Study of the Safety and Tolerability of REGN668(SAR231893) in Normal Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint in the study is the incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN668 or Placebo from baseline through week 12.
12 weeks
The primary endpoint in the study is the incidence of treatment-emergent adverse events in subjects treated with REGN668 or placebo, reported from the administration of study drug on day 1 to the completion of the study on day 85/visit 11.
85 days

Secondary Endpoints

The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12.
12 weeks
Pharmacokinetics: Serum concentrations of REGN668 over time.
85 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Cohort 3EXPERIMENTAL -
Dose 1EXPERIMENTAL(3:1, active:placebo)
Dose 2EXPERIMENTAL(3:1, active:placebo)
Dose 3EXPERIMENTAL(3:1, active:placebo)
Dose 4EXPERIMENTAL(3:1, active:placebo)

Interventions

NameTypeDescription
REGN668BIOLOGICALDose 1: REGN668 or placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Clinical diagnosis of atopic dermatitis that has been present for at least 3 years before the screening visit * Investigator's Global Assessment (IGA) score of \>/= 3 at the screening and baseline visits * \>/= 15% body surface area (BSA) of AD involvement at the screening and...

Countries:United States
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Frequently asked questions about REGN668

What is REGN668 used for?

REGN668 is an investigational monoclonal antibody being studied for use in healthy volunteers and in patients with atopic dermatitis, a form of dermatitis. It is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes REGN668?

REGN668 is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker symbol REGN on the NASDAQ. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug.

What phase is REGN668 in?

REGN668 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied in clinical trials to assess its safety and tolerability in humans.

What clinical trials is REGN668 in?

REGN668 has been studied in two completed Phase 1 clinical trials. The first, NCT01015027, was an ascending dose study in healthy volunteers. The second, NCT01259323, was a sequential ascending dose study in patients with atopic dermatitis. Both trials were conducted in the United States.

Is REGN668 the same as SAR231893?

Yes, REGN668 is also known as SAR231893. Both names refer to the same investigational monoclonal antibody being developed by Regeneron Pharmaceuticals. Clinical trials have used both names to describe the drug.