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

Phase 1

Terminated

• Conditions: Pruritus; Atopic Dermatitis
• Interventions: Drug: REGN846

• Registration Number: NCT01605708
• Lead Sponsor: Regeneron Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-12
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-25
• Study Start: 2012-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Disposition First Submitted: 2013-09-27
• Disposition First Submitted QC: 2013-09-27
• Last Update Submitted: 2013-09-27
• Disposition First Posted: 2013-10-28
• Last Update Posted: 2013-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1	REGN846	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.