A Study for Adults With Plaque Psoriasis

Lilly

Status and phase: Terminated; Phase 2

Conditions: Psoriasis

Treatments: Drug: LY2525623 Subcutaneous; Drug: Placebo Subcutaneous; Drug: LY2525623 Intravenous; Drug: Placebo Intravenous

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018810

11431

I1X-MC-BDAD (Other Identifier)

Details and patient eligibility

About

In this study, we will evaluate clinical activity, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of 5 LY2525623 dosing groups compared to placebo in adults with plaque psoriasis.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are ambulatory and greater than or equal to 18 years of age. Females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a highly reliable method of birth control as defined by those which result in a low failure rate(<1% per year) during the study.
• Chronic psoriasis vulgaris for at least 6 months prior to randomization.
• Moderate and severe (plaque) psoriasis involving at least 10% body surface area (BSA) or at least 8% BSA in subjects with severe palmar-plantar involvement at randomization.
• Psoriasis Area and Severity Index (PASI) total score of at least 12 at screening.

Exclusion criteria

• Have had a clinically significant flare of psoriasis during the 12 weeks prior to randomization or a biologic agent/monoclonal antibody within the longer of 5 half lives or 12 weeks prior to dosing, had systemic treatment for psoriasis or phototherapy within 4 weeks prior to dosing, or had topical psoriasis treatment within 2 weeks prior to dosing.

• Have had a vaccination within 4 to 12 weeks (depending on type) prior to or intend to have one within 4 weeks after the dosing period.

• Are immunocompromised or have evidence of active infection (such as viral hepatitis and/or positive testing for tuberculosis or human immunodeficiency virus [HIV]); or have had a recent serious systemic infection (such as mononucleosis or herpes zoster).

• Have a history of or current lymphoproliferative disease or malignant disease (except for resolved cervical dysplasia; or no more than 3 successfully treated basal- or squamous- cell carcinomas of the skin), or severe drug allergies/hypersensitivity.

• Have a history of serious cardiac disease within 12 weeks before randomization; or have serious or unstable/uncontrolled illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study.

• Have laboratory test values outside the reference range for the population or investigative site that are considered clinically significant and/or have any of the following specific abnormalities:

  • Aspartate transaminase (AST) or alanine transaminase (ALT) >2 x the upper limit of normal (ULN; upper reference range of the central laboratory for the study)
  • Hemoglobin <100 g/L (10 g/dL)
  • White blood cell (WBC) <3.0 G/L (3,000/mm3)
  • Neutrophils <1.5 G/L (1,500/mm3)
  • Platelets <75 G/L (75,000/mm3)
  • Serum creatinine >133 µmol/L (1.5 mg/dL)
  • Random glucose >11.1mmol/L (200 mg/dL).

• Have significant allergies to humanized monoclonal antibodies, or clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

8 participants in 7 patient groups, including a placebo group

180 mg LY2525623

Experimental group

Treatment:

Drug: LY2525623 Intravenous

Intravenous Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Intravenous

Subcutaneous Placebo

Placebo Comparator group

Treatment:

Drug: Placebo Subcutaneous

3 mg LY2525623

Experimental group

Treatment:

Drug: LY2525623 Subcutaneous

10 mg LY2525623

Experimental group

Treatment:

Drug: LY2525623 Subcutaneous

30 mg LY2525623

Experimental group

Treatment:

Drug: LY2525623 Subcutaneous

90 mg LY2525623

Experimental group

Treatment:

Drug: LY2525623 Subcutaneous