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BI 655066

Phase 1

Psoriasis | Small molecule | Dermatology |AbbVie Inc.|Last Updated: Nov 16, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

BI 655066 · 1 trial · 1 indication

Phase 1 1
NCT01577550Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe PsoriasisPsoriasis
COMPLETED39 Analytics
PHASE1COMPLETED
Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of patients with good and satisfactory assessment of global tolerability by investigator
24 weeks
Number of patients without any symptoms at the drug administration site, at per local assessment of tolerability by investigator
up to 1 week
Number of participants with adverse events
up to 24 weeks
Number of participants with clinically relevant findings in vital signs
up to 24 weeks
Number of participants with clinically significant abnormalities in electrocardiogramm (ECG) results
up to 24 weeks
Number of participants with significant changes from baseline laboratory measurements
up to 24 weeks

Secondary Endpoints

Psoriasis Area and Severity Index (absolute score)
up to 24 weeks
Percentage of participants with Static Physicians Global Assessment (clear and almost clear)
up to 24 weeks
Cmax (maximum measured concentration of the analyte in plasma)
up to 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
i.v. BI 655066EXPERIMENTALA subject to receive a single i.v. dose of BI 655066
i.v. placeboPLACEBO_COMPARATORA subject to receive a single i.v. dose of placebo
s.c. BI 655066EXPERIMENTALA subject to receive a single s.c. dose of BI 655066
s.c. placeboPLACEBO_COMPARATORA subject to receive a single s.c. dose of placebo

Interventions

NameTypeDescription
BI 655066 (very high i.v. dose)DRUGSingle very high i.v. dose BI 655066
Placebo, i.v.DRUGSingle i.v. administration of placebo
BI 655066 (high s.c. dose)DRUGSingle high s.c. dose BI 655066
BI 655066 (low i.v. dose)DRUGSingle low i.v. dose BI 655066
BI 655066 (high medium i.v. dose)DRUGSingle high medium i.v. dose BI 655066
BI 655066 (very low i.v. dose)DRUGSingle very low i.v. dose BI 655066
BI 655066 (low s.c. dose)DRUGSingle low s.c. dose BI 655066
BI 655066 (high i.v. dose)DRUGSingle high i.v. dose BI 655066
Placebo, s.c.DRUGSingle s.c. administration of placebo
BI 655066 (low medium i.v. dose)DRUGSingle low medium i.v. dose BI 655066
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: 1. Male or female patients aged 18-75 years (inclusive) 2. Chronic moderate to severe plaque psoriasis lasting =\>6 months with involvement of Body Surface Area (BSA) =\>10%, Psoriasis Area and Severity Index (PASI) =\>12 and Static Physician Global Assessment (sPGA) score of mo...

Countries:United StatesGermanyUnited Kingdom
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Frequently asked questions about BI 655066

What is BI 655066 used for in psoriasis?

BI 655066 is an investigational small molecule being developed for the treatment of moderate to severe psoriasis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. A single rising dose study has been completed in patients with this condition.

Who makes BI 655066?

BI 655066 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 1 clinical development for psoriasis.

What phase is BI 655066 in?

BI 655066 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 trial has been completed, and the drug remains under investigation for the treatment of moderate to severe psoriasis.

What clinical trials is BI 655066 in?

BI 655066 has one completed Phase 1 clinical trial, identified as NCT01577550, titled "Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis." The trial enrolled 39 participants and was conducted in the United States, Germany, and the United Kingdom.

Is BI 655066 FDA approved?

BI 655066 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for psoriasis. The drug has completed a Phase 1 trial, but it has not received regulatory approval and remains under clinical investigation.