A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Chugai Pharmaceutical
Study ID
NCT01986933
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy

Key Dates

Start date
Nov 30, 2013
Status verified
Jan 2022
Primary completion
Apr 30, 2015
Completion
Jun 30, 2016

Study Design

Enrollment
264 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group1
    Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
  • Experimental: Group2
    Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
  • Experimental: Group3
    Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
  • Experimental: Group4
    Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331)
  • Experimental: Group5
    Part A: Placebo Part B: nemolizumab (CIM331)

Primary Outcome Measure

Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 [ Time Frame: baseline to Week 12 ]

Locations (18)

FacilityCityStateZIPSite coordinators
-AnnistonAlabama36207-
-San DiegoCalifornia92122-
-MiamiFlorida33142-
-AlpharettaGeorgia30022-
-Arlington HeightsIllinois60005-
-ChicagoIllinois60612-
-IndianapolisIndiana46256-
-LouisvilleKentucky40202-
-LouisvilleKentucky40217-
-Bay CityMichigan48706-
-New YorkNew York10016-
-CharlotteNorth Carolina28226-
-ClevelandOhio44106-
-PortlandOregon97239-
-CharlestonSouth Carolina29407-
-CharlestonSouth Carolina29425-
-College StationTexas77845-
-NorfolkVirginia23507-

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