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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01605708
First received: October 12, 2011
Last updated: September 27, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Pruritus
Atopic Dermatitis
Drug: REGN846
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Clinical Activity [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 - Week 6 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Week 1 - Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 1 - Week 6 ] [ Designated as safety issue: No ]
    To assess the immunogenicity of REGN846 in adult patients who have moderate-to-severe AD with refractory moderate-to-severe pruritus.


Enrollment: 19
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: REGN846
Dose 1

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605708

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
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01605708     History of Changes
Other Study ID Numbers: R846-AD-1105
Study First Received: October 12, 2011
Last Updated: September 27, 2013
Health Authority: Finland: Finnish Medicines Agency
Germany: Ethics Commission
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Regeneron Pharmaceuticals:
Itching

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Pruritus
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 15, 2014