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Multiple SclerosisPhase 2NCT00109161

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

A Phase 2 study testing Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) in people with Multiple Sclerosis, run by PDL BioPharma, Inc. at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)
How many people
270 participants
Where
36 sitesin 2 countries
Study dates
Apr 2005to Oct 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

United States30 sites

  • Upstate Clinical Research

    Albany, New York, 12205

  • Albany Medical Center

    Albany, New York, 12208

  • The Multiple Sclerosis Center of Atlanta

    Atlanta, Georgia, 30327

  • Maryland Center for MS

    Baltimore, Maryland, 21201

  • Sutter East Bay Medical Foundation

    Berkeley, California, 94705

  • MS Center/CMC Meyers Park

    Charlotte, North Carolina, 28207

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • The MS Center at Texas Neurology

    Dallas, Texas, 75214

  • Wayne State University MS Center

    Detroit, Michigan, 48201

  • Michigan State University

    East Lansing, Michigan, 48824

  • Michigan Medical P.C. Neurology

    Grand Rapids, Michigan, 49525

  • KUMC Neurology

    Kansas City, Kansas, 66160

  • MS Center at Dartmouth

    Lebanon, New Hampshire, 03756

  • Neurology Associates, P.A.

    Maitland, Florida, 32751

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Hospital for Joint Diseases, MS Care Center

    New York, New York, 10003

  • Consultants in Neurology

    Northbrook, Illinois, 60062

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Central Texas Neurology

    Round Rock, Texas, 78681

  • University of Utah CAMT

    Salt Lake City, Utah, 84108

  • Mayo Clinic

    Scottsdale, Arizona, 85013

  • MS Hub Medical Group

    Seattle, Washington, 98101

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana, 71103

  • Rockwood Clinic, PS

    Spokane, Washington, 99202

  • St. Louis University Hospital

    St Louis, Missouri, 63110

  • Gimble MS Center

    Teaneck, New Jersey, 07666

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

Other trials in United States

Canada6 sites

  • Foothills Medical Centre-MS Research Program

    Calgary, Alberta, T2N 2T9

  • University of Alberta

    Edmonton, Alberta, T6G-2C8

  • Clinique SEP/NM

    Gatineau, Quebec, PQ J8Y 1W7

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Montreal Neurological Institute

    Montreal, Quebec, H3A 2B4

  • Health Sciences Center

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

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

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).

Read the detailed description

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

Being tested
Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)
Keywords
Multiple Sclerosis, MS, CNS, Daclizumab
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 outcomes (3)

  1. Pharmacokinetics

  2. Immunogenicity

  3. Clinical improvement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2005 (estimated)
  2. Study startApr 2005
  3. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
270 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00109161
Sponsor's protocol ID
DAC-1012
Status last verified
Aug 2008
First submitted
22 Apr 2005
Last updated
5 Aug 2008
Results posted
No

Publications

  • Wynn D, Kaufman M, Montalban X, Vollmer T, Simon J, Elkins J, O'Neill G, Neyer L, Sheridan J, Wang C, Fong A, Rose JW; CHOICE investigators. Daclizumab in active relapsing multiple sclerosis (CHOICE study): a phase 2, randomised, double-blind, placebo-controlled, add-on trial with interferon beta. Lancet Neurol. 2010 Apr;9(4):381-90. doi: 10.1016/S1474-4422(10)70033-8. Epub 2010 Feb 15.

    PubMed 20163990

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) in people with Multiple Sclerosis, run by PDL BioPharma, Inc. at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00109161, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2008.

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