Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109161
• Other study ID #: DAC-1012
• Status: Completed
• Phase: Phase 2
• First received: April 22, 2005
• Last updated: August 2, 2008
• Start date: April 2005
• Est. completion date: October 2006

Study information

• Verified date: August 2008
• Source: Facet Biotech
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This research study is being conducted in the U.S. and Europe to evaluate the safety and efficacy of daclizumab for the treatment of multiple sclerosis (MS).

Description:

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male or female age 18 to 55 years, inclusive.

• Diagnosis of MS by McDonald criteria.

• EDSS <7.0.

• On stable IFN-beta regimen for at least 6 months.

• The occurrence of either of the following within 9 months prior to screening: =1 MS relapse OR A qualifying MRI, defined as an MRI that showed at least one confirmed Gd-CEL of the brain or spinal cord, was performed independently of the study while the patient was on a stable IFN-beta regimen, and is deemed acceptable by the central reader.

• For females, women of non-childbearing potential or women of childbearing potential who provide a negative serum pregnancy test at screen and within 24 hours of first dose of study drug, and who agree to use effective contraception during the Treatment and Follow-up periods of the study.

• Willing and able to comply with the protocol, provision of informed consent in accordance with institutional and regulatory guidelines, and, for US sites only, authorization to use protected health information.

Exclusion Criteria:

• Pregnant or breast-feeding woman.

• Non-ambulatory patient.

• Clinically significant abnormality on screening ECG.

• Malignancy within the past 5 years, except for adequately treated non-melanoma skin carcinoma or in situ carcinoma of the cervix.

• History of HIV infection, positive serology for HBV (hepatitis B virus) or HCV (hepatitis C virus).

• Varicella (VZV) or herpes zoster virus infection, or any severe viral infection, within 6 weeks before screening or exposure to VZV within 21 days of screening.

• Abnormal hematology, as defined by the following laboratory values: *Hemoglobin =8.5 g/dL, *Lymphocytes =1.0 x 10^9/L, *Platelets =100 x 10^9/L, *Neutrophils =1.5 x 10^9/L.

• Significant organ dysfunction, including but not limited to cardiac, renal, liver, non-MS related CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic dysfunction, or other disease or condition, which in the opinion of the PI (principal investigator) would make the patient an unsuitable candidate for the study. Guidelines for levels of unacceptable dysfunction include: *creatinine =1.6 mg/dL; *AST and ALT =2.5 times upper limit of normal (ULN); *alkaline phosphatase =2.5 times ULN; *history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to randomization.

• Use of any of the following: *Any of the following types of live virus vaccine from 4 weeks before randomization: measles/mumps/rubella vaccine, varicella zoster virus vaccine, oral polio vaccine, and nasal influenza vaccine. Use of these vaccines, however, by household contacts does not affect the eligibility of patients to enroll or continue in the study; *Systemic corticosteroids, adrenocorticotropic hormone, or plasma exchange within 4 weeks before the baseline MRI scan (no more than 72 hours before Day 0); *Azathioprine, mycophenolate mofetil, methotrexate, glatiramer acetate, or intravenous immune globulin within 6 months before randomization; *An immunomodulatory agent within 6 months before randomization, except for interferon-beta products required per protocol; *An investigational agent within 6 months before randomization unless this agent is non-immunomodulatory and the medical monitor or steering committee rules that its use is acceptable on the theoretical basis of a lapse of at least 5 serum half-lives since administration of the last possible dose; *A monoclonal antibody (eg, Rituxan®/ Rituximab) within 6 months before randomization; *Daclizumab at any time prior to randomization; *Cladribine, mitoxantrone, cyclophosphamide, CamPath® (alemtuzumab), natalizumab (TYSABRI®/Antegren) or other drugs targeting alpha 4 integrin, total lymphoid irradiation, or bone marrow transplant at any time

• Patients for whom MRI is contraindicated, ie, have pacemakers or other contraindicated implanted metal devices, are allergic to gadolinium, or have claustrophobia that cannot be medically managed.

• Primary progressive MS.

• Clinically unstable for 30 days before randomization (Patients who experienced a relapse, with or without steroid treatment, during the screening period may be re-screened after 30 days.)

• Elective surgery performed from 2 weeks prior to randomization or scheduled through Week 44

• Infection (viral, fungal, bacterial) requiring hospitalization or IV antibiotics within 8 weeks before randomization.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)

Locations

Country	Name	City	State
Canada	Foothills Medical Centre-MS Research Program	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Clinique SEP/NM	Gatineau	Quebec
Canada	London Health Sciences Centre	London	Ontario
Canada	Montreal Neurological Institute	Montreal	Quebec
Canada	Health Sciences Center	Winnipeg	Manitoba
United States	Albany Medical Center	Albany	New York
United States	Upstate Clinical Research	Albany	New York
United States	The Multiple Sclerosis Center of Atlanta	Atlanta	Georgia
United States	Maryland Center for MS	Baltimore	Maryland
United States	Sutter East Bay Medical Foundation	Berkeley	California
United States	MS Center/CMC Meyers Park	Charlotte	North Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	The MS Center at Texas Neurology	Dallas	Texas
United States	Wayne State University MS Center	Detroit	Michigan
United States	Michigan State University	East Lansing	Michigan
United States	Michigan Medical P.C. Neurology	Grand Rapids	Michigan
United States	KUMC Neurology	Kansas City	Kansas
United States	MS Center at Dartmouth	Lebanon	New Hampshire
United States	Neurology Associates, P.A.	Maitland	Florida
United States	Winthrop University Hospital	Mineola	New York
United States	Hospital for Joint Diseases, MS Care Center	New York	New York
United States	Consultants in Neurology	Northbrook	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	University of Rochester Medical Center	Rochester	New York
United States	Central Texas Neurology	Round Rock	Texas
United States	University of Utah CAMT	Salt Lake City	Utah
United States	Mayo Clinic	Scottsdale	Arizona
United States	MS Hub Medical Group	Seattle	Washington
United States	Louisiana State University Health Sciences Center	Shreveport,	Louisiana
United States	Rockwood Clinic, PS	Spokane	Washington
United States	St. Louis University Hospital	St. Louis	Missouri
United States	Gimble MS Center	Teaneck	New Jersey
United States	Wenatchee Valley Medical Center	Wenatchee	Washington

Sponsors (1)

Lead Sponsor	Collaborator
PDL BioPharma, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
Secondary	Pharmacokinetics
Secondary	Immunogenicity
Secondary	Clinical improvement

External Links

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