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

This study has been completed.
Sponsor:
Information provided by:
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00109161
First received: April 22, 2005
Last updated: August 2, 2008
Last verified: August 2008
  Purpose

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).


Condition Intervention Phase
Multiple Sclerosis
Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Pharmacokinetics
  • Immunogenicity
  • Clinical improvement

Estimated Enrollment: 270
Study Start Date: April 2005
Estimated Study Completion Date: October 2006
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109161

  Show 36 Study Locations
Sponsors and Collaborators
PDL BioPharma, Inc.
Investigators
Principal Investigator: Richard Dickson, M.D. Wenatchee Valley Medical Center
Principal Investigator: Steven Pugh, M.D. Rockwood Clinic, PS
Principal Investigator: Daniel Wynn, M.D. Consultants in Neurology
Principal Investigator: Theodore J. Phillips, M.D. The MS Center at Texas Neurology
Principal Investigator: Joanna Cooper Sutter East Bay Medical Foundation
Principal Investigator: James R. Storey Upstate Clinical Research
Principal Investigator: Malcolm Gottesman, M.D. Winthrop University Hospital
Principal Investigator: Herman Sullivan, M.D. Michigan Medical P.C. Neurology
Principal Investigator: Timothy Vollmer, M.D. St. Joseph's Hospital and Medical Center, Phoenix
Principal Investigator: Jeffery Dunn, M.D. MS Hub Medical Group
Principal Investigator: S. Mitchell Freedman, M.D. Raleigh Neurology Associates
Principal Investigator: Joseph Herbert, M.D. Hospital for Joint Diseases, MS Care Center
Principal Investigator: Omar Khan, M.D. Wayne State University MS Center
Principal Investigator: Marcelo Kremenchutzky, M.D. London Health Sciences Centre
Principal Investigator: Sharon Lynch, M.D. CLMC Neurology
Principal Investigator: Alireza Minagar, M.D. Louisiana State University Health Sciences Center
Principal Investigator: Jeffrey English, M.D. The Multiple Sclerosis Center of Atlanta
Principal Investigator: Andrew Goodman, M.D. University of Rochester
Principal Investigator: Michael Kaufman, M.D. MS Center/CMC
Principal Investigator: Florian P. Thomas, M.D. St. Louis University Hospital
Principal Investigator: Clyde Markowitz, M.D. University of Pennsylvania
Principal Investigator: Jayne Martin, M.D. Michigan State University
Principal Investigator: Maria Melanson, M.D. Health Sciences Center
Principal Investigator: MaryAnn Picone, M.D. Gimble MS Center
Principal Investigator: Christopher Bever, M.D Maryland Center for MS
Principal Investigator: Gregg G. Blevins, M.D. University of Alberta
Principal Investigator: Kasper Lloyd, M.D. MS Center at Dartmouth
Principal Investigator: Yves Lapierrre, M.D. Montreal Neurological Institute
Principal Investigator: John W. Rose, M.D. University of Utah CAMT
Principal Investigator: Michael Yeung, M.D. Foothills Medical Centre
Principal Investigator: Neil Lava, M.D. Albany Medical College
Principal Investigator: Jonathan L. Carter, M.D. Mayo Clinic
Principal Investigator: Francois Jacques, M.D. Clinique SEP/NM
Principal Investigator: William Honeycutt, M.D. Neurology Associates, P.A.
Principal Investigator: Istvan Pirko, M.D. University of Cincinnati
Principal Investigator: Ed Fox, M.D. Central Texas Neurology
  More Information

Additional Information:
No publications provided by Facet Biotech

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00109161     History of Changes
Other Study ID Numbers: DAC-1012
Study First Received: April 22, 2005
Last Updated: August 2, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
Multiple Sclerosis, MS, CNS, Daclizumab

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Antibodies, Monoclonal
Daclizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on July 20, 2014