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

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).

Study Overview

• Status: Terminated
• Conditions: Pruritus; Atopic Dermatitis
• Intervention / Treatment: Drug: REGN846

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
  • Tampere, Finland
• Germany
  • Berlin, Germany
  • Dresden, Germany
  • Erfurt, Germany
  • Frankfurt, Germany
  • Mahlow, Germany
  • Mainz, Germany
  • Osnabrueck, Germany
  • Tuebingen, Germany
• Poland
  • Bydgoszcz, Poland
  • Poznan, Poland
  • Warszawa, Poland
  • Wroclaw, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Exclusion Criteria:

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

1. A history of listeriosis.

2. Presence of any 1 of the following tuberculosis (TB) criteria:

   1. A history of active TB
   2. A positive QuantiFERON TB test at the screening visit
   3. 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.
3. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit.
4. Any clinically significant physical abnormalities observed during the screening visit.
5. Diabetic, hypertensive, or any known atherosclerotic vascular disease.
6. Hospitalization for any reason within 60 days of the screening visit.
7. History of or positive human immunodeficiency virus (HIV) screen result at the screening visit.
8. History of positive blood test for hepatitis B/hepatitis C or positive hepatitis screen result at the screening visit.
9. Known sensitivity to doxycycline or tetracycline.
10. Known sensitivity to any of the components or excipients of the investigational product formulation or history of hypersensitivity to any biologic agent.
11. 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.
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1	Drug: REGN846; Dose 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Activity	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.	Week 2
Clinical Activity	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.	Week 4
Clinical Activity	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.	Week 6

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): October 28, 2013
• Last Update Submitted That Met QC Criteria: September 27, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Itching
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Manifestations; Skin Diseases, Eczematous; Dermatitis; Eczema; Pruritus; Dermatitis, Atopic
• Other Study ID Numbers: R846-AD-1105