A Multicenter Study to Evaluate the Safety and Tolerability of Single-Dose for MEDI-545

NCT00472758 | Completed Phase 1 DMC

• 1 other identifier: MI-CP145
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

-To evaluate the safety and tolerability of a multiple doses of this drug in adult patients.

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of MEDI-545 will be assessed through the collection of AEs and SAEs from study drug administration through Study Day 126.

  Through day 26

Secondary Outcomes (1)

• Secondary endpoints are the PK and IM of single-dose IV MEDI-545.

  determination not stated

Study Arms (2)

1

ACTIVE COMPARATOR

MEDI 545

Biological: MEDI 545

2

PLACEBO COMPARATOR

Placebo IV

Other: Placebo

Interventions

MEDI 545 BIOLOGICAL

IV dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg

1

Placebo OTHER

IV Placebo dosed at 1.0 mg/kg, 3.0,g/kg, 10.0mg/kg and 30.0mg/kg

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults, age 18 through 70 years of age at time of screening;
• Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures;
• Documented clinical history of chronic plaque psoriasis;
• ≥ 3% body surface area (BSA) involvement in affected skin other than the face and scalp;
• Have at least two target plaques that are suitable for serial photographic assessments, one of which is of a size and location to allow serial biopsies;
• No significant changes in regular psoriasis treatment from at least 28 days from screening through the time of study drug administration;
• Sexually active women, unless surgically sterile or at least 1 year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, abstinence, use of a condom with spermicide by the sexual partner or sterile sexual partner) for 21 days prior to study drug administration, and must agree to continue using such precautions through Study Day 126. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active men, unless surgically sterile, must likewise use an effective method of birth control (condom with spermicide) and must agree to continue using such precautions through Study Day 126;
• Willing to forego other forms of experimental treatment and study procedures during the study; and
• Ability to complete the study period, including follow-up period through Study Day 126.

You may not qualify if:

• Receipt of MEDI-545 in any previous clinical study;
• History of allergy or reaction to any component of the MEDI-545 formulation;
• Pustular, guttate, or erythrodermic psoriasis as the predominant disease type;
• Current use of potent topical corticosteroids, tacrolimus, or calcipotriol from 28 days prior to screening through study drug administration;
• Current use of phototherapy including tanning beds, Goeckerman or modified Goeckerman regimen, systemic corticosteroids, cyclosporin A, azathioprine, mycophenolate mofetil, methotrexate, or any other systemic treatment for psoriasis within 28 days prior to screening up through study drug administration;
• Current use of biologic agents such as alefacept or tumor necrosis factor-α inhibitors within 90 days prior to screening up through study drug administration;
• Any disease or illness, other than chronic plaque psoriasis, that may require the use of systemic corticosteroids during the study period;
• Acute illnesses or evidence of significant active infection, such as fever ≥ 38.0°C (≥ 100.5°F) from screening through study drug administration;
• Receipt of any investigational drug therapy or attenuated live vaccine therapy (other than vaccination against influenza) within 30 days or 5 half-life periods (whichever is longer) prior to study drug administration through the end of study;
• Pregnancy (sexually active women, unless surgically sterile or at least 1 year post-menopausal, must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to study drug administration on Study Day 0);
• Breastfeeding or lactating women;
• Evidence of infection with hepatitis B or C virus, or human immunodeficiency virus (HIV)-1 or -2, or active infection with hepatitis A, as determined by results of testing at screening;
• A history of severe infection with cytomegalovirus or viruses of the herpes family including Epstein-Barr virus requiring hospitalization, disseminated herpes, herpes encephalitis, or ophthalmic herpes;
• Herpes zoster within 3 months prior to screening;
• Current suppressive antiviral therapy for herpes or other viral infections;

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (3)

Innovaderm Research, Laval, Inc.

Laval-Quebec, H7S 2C5, Canada

Location

Innovaderm Research, Inc.

Montreal, H2K 4L5, Canada

Location

Probity Medical Research

Waterloo- Ontario, N2J 1C4, Canada

Location

MeSH Terms

Interventions

sifalimumab

Study Officials

• Barbara White, M.D.

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 14, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

CA (3)