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

NCT01605708 | Terminated Phase 1

• 1 other identifier: R846-AD-1105
• Study Type: interventional
• Target: 19
• Locations: 3 countries
• Sites: 14

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).

Conditions

Pruritus; Atopic Dermatitis

Keywords

Itching

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Safety and tolerability a single IV dose of REGN846

  Week 1 - Week 6

• Pharmacokinetic (PK) profile of a single IV dose of REGN846

  Week 1 - Week 6

• Immunogenicity of a single IV dose of REGN846

  Week 1 - Week 6

Study Arms (1)

Cohort 1

EXPERIMENTAL

Drug: REGN846

Interventions

REGN846 DRUG

Dose 1

Cohort 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (14)

Unknown Facility

Helsinki, Finland

Location

Unknown Facility

Tampere, Finland

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Dresden, Germany

Location

Unknown Facility

Erfurt, Germany

Location

Unknown Facility

Frankfurt, Germany

Location

Unknown Facility

Mahlow, Germany

Location

Unknown Facility

Mainz, Germany

Location

Unknown Facility

Osnabrück, Germany

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Bydgoszcz, Poland

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

MeSH Terms

Conditions

Pruritus; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2011
• First Posted: May 25, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: October 28, 2013

Record last verified: 2013-05

Locations

PL (4); FI (2); DE (8)