Study to Assess the Clinical Activity of a Sequential Dose of REGN846 on Refractory Pruritus in Patients With Atopic Dermatitis

Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending Dose Study of the Clinical Activity, Safety, Tolerability and Pharmacokinetics of a Single IV Dose of REGN846 in Refractory Moderate-to-Severe Pruritus in Adult Patients With Moderate-to-Severe Atopic Dermatitis

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01605708

Enrollment

Registered

2012-05-25

Start date

2012-06-30

Completion date

2013-04-30

Last updated

2013-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Pruritus

Keywords

Itching

Brief summary

The purpose of this study is to assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe atopic dermatitis (AD).

Interventions

DRUGREGN846

Dose 1

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Inclusion criteria include, but are not limited to the following: 1. Men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile 2. Patients must have applied a stable dose of an additive-free, basic, bland emollient twice daily for at least 7 days before the baseline visit 3. Chronic Atopic Dermatitis (AD) 4. Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive. 5. Refractory pruritus for ≥ 6 weeks before screening. Pruritus should be associated only with AD and not with any other condition(s). 6. Itching associated with AD

Design outcomes

Primary

Measure	Time frame	Description
Clinical Activity	Week 2	To assess the clinical activity on refractory moderate-to-severe pruritus of a single intravenous (IV) dose of REGN846 in adult patients with moderate-to-severe AD.

Secondary

Measure	Time frame	Description
Safety and tolerability a single IV dose of REGN846	Week 1 - Week 6	To assess the safety and tolerability of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.
Pharmacokinetic (PK) profile of a single IV dose of REGN846	Week 1 - Week 6	To assess the PK profile of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.
Immunogenicity of a single IV dose of REGN846	Week 1 - Week 6	To assess the immunogenicity of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.

Countries

Finland, Germany, Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026