Study to Assess the Clinical Activity of a Sequential Dose of REGN846 on Refractory Pruritus in Patients With Atopic Dermatitis
NCT ID: NCT01605708
Last Updated: 2013-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
19 participants
INTERVENTIONAL
2012-06-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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Cohort 1
REGN846
Dose 1
Interventions
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REGN846
Dose 1
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Helsinki, , Finland
Tampere, , Finland
Berlin, , Germany
Dresden, , Germany
Erfurt, , Germany
Frankfurt, , Germany
Mahlow, , Germany
Mainz, , Germany
Osnabrück, , Germany
Tübingen, , Germany
Bydgoszcz, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Countries
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Other Identifiers
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R846-AD-1105
Identifier Type: -
Identifier Source: org_study_id