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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT01605708

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

1.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pruritus Atopic Dermatitis	Drug: REGN846	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1	Drug: REGN846 Dose 1

Arm

Intervention/Treatment

Experimental: Cohort 1

Drug: REGN846

Dose 1

Outcome Measures

Primary Outcome Measures

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.
Clinical Activity [Week 4]
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.
Clinical Activity [Week 6]
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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inclusion criteria include, but are not limited to the following:

Men and women between the ages of 18 and 65; women must be postmenopausal or surgically sterile
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
Chronic Atopic Dermatitis (AD)
Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
Refractory pruritus for ≥ 6 weeks before screening. Pruritus should be associated only with AD and not with any other condition(s).
Itching associated with AD

Exclusion Criteria:

Exclusion criteria include, but are not limited to the following:

A history of listeriosis.
Presence of any 1 of the following tuberculosis (TB) criteria:
A history of active TB
A positive QuantiFERON TB test at the screening visit
Chest radiograph (posterior-anterior and lateral views) at screening or within 3 months before the screening visit (radiology report must be available) with results consistent with prior TB infection (including but not limited to apical scarring, apical fibrosis, or multiple calcified granuloma). This does not include non-caseating granulomata.
Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit.
Any clinically significant physical abnormalities observed during the screening visit.
Diabetic, hypertensive, or any known atherosclerotic vascular disease.
Hospitalization for any reason within 60 days of the screening visit.
History of or positive human immunodeficiency virus (HIV) screen result at the screening visit.
History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit.
Known sensitivity to doxycycline or tetracycline.
Known sensitivity to any of the components or excipients of the investigational product formulation or history of hypersensitivity to any biologic agent.
Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to the screening visit.
Any medical or psychiatric condition that in the opinion of the investigator or Regeneron, would place the patient at risk, interfere with participation in the study or interfere with the interpretation of study results.

Contacts and Locations

Locations

	City	Country
1	Helsinki	Finland
2	Tampere	Finland
3	Berlin	Germany
4	Dresden	Germany
5	Erfurt	Germany
6	Frankfurt	Germany
7	Mahlow	Germany
8	Mainz	Germany
9	Osnabrueck	Germany
10	Tuebingen	Germany
11	Bydgoszcz	Poland
12	Poznan	Poland
13	Warszawa	Poland
14	Wroclaw	Poland