BI 655066 Dose Ranging in Psoriasis, Active Comparator Ustekinumab

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT02054481
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BI 655066 — DRUG
    Medium dose
  • BI 655066 — DRUG
    High dose
  • Ustekinumab — DRUG
  • BI 655066 — DRUG
    Low dose

Study Details

The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066 in adult patients with chronic plaque psoriasis in order to select doses for further clinical trials.

Key Dates

Start date
Feb 28, 2014
Status verified
Jul 2016
Primary completion
Nov 30, 2014
Completion
Jul 31, 2015

Study Design

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

Arms

  • Experimental: Arm 1
    BI 655066 s.c.
  • Experimental: Arm 2
    BI 655066 s.c.
  • Experimental: Arm 3
    BI 655066 s.c.
  • Active Comparator: Arm 4
    Ustekinumab s.c.

Primary Outcome Measure

Achievement of ≥90% Reduction From Baseline PASI Score (PASI90) at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (12)

FacilityCityStateZIPSite coordinators
1311.2.10010 Boehringer Ingelheim Investigational SiteLos AngelesCalifornia--
1311.2.10013 Boehringer Ingelheim Investigational SitePort OrangeFlorida--
1311.2.10003 Boehringer Ingelheim Investigational SiteArlington HtsIllinois--
1311.2.10002 Boehringer Ingelheim Investigational SiteBay CityMichigan--
1311.2.10004 Boehringer Ingelheim Investigational SiteFridleyMinnesota--
1311.2.10001 Boehringer Ingelheim Investigational SiteEast WindsorNew Jersey--
1311.2.10009 Boehringer Ingelheim Investigational SiteVeronaNew Jersey--
1311.2.10007 Boehringer Ingelheim Investigational SiteRaleighNorth Carolina--
1311.2.10005 Boehringer Ingelheim Investigational SitePortlandOregon--
1311.2.10006 Boehringer Ingelheim Investigational SiteDallasTexas--
1311.2.10011 Boehringer Ingelheim Investigational SiteHoustonTexas--
1311.2.10012 Boehringer Ingelheim Investigational SiteSpokaneWashington--

Find similar trials in Los Angeles, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
1311.2.10010 Boehringer Ingelheim Investigational Site· Los Angeles, CA1311.2.10013 Boehringer Ingelheim Investigational Site· Port Orange, FL1311.2.10003 Boehringer Ingelheim Investigational Site· Arlington Hts, IL1311.2.10002 Boehringer Ingelheim Investigational Site· Bay City, MI1311.2.10004 Boehringer Ingelheim Investigational Site· Fridley, MN1311.2.10001 Boehringer Ingelheim Investigational Site· East Windsor, NJ

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