Clinical trial NCT00086671 (phase 2, status: completed)
Conditions: multiple sclerosis
ICD codes: G35, C81.18
Drugs: abt-874/human monoclonal antibody against il-12, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 and 55 years

          -  Diagnosis of active relapse within 12 months of screening.

          -  At least one relapse within 12 months of screening.

          -  Must be able to walk at least 65 feet with or without assistance

          -  Off Copaxone or interferon therapy for two months prior to screening

          -  Able and willing to learn to self-administer weekly injections, or have a designee who
             will administer study medication

          -  Female participants must use contraceptives while on study drug

        Exclusion Criteria:

          -  Primary progressive multiple sclerosis (PPMS)

          -  Immunosuppressive therapy (such as azathioprine, methotrexate (MTX), but excluding
             corticosteroids) within six months of randomization. Subjects with previous treatment
             with cyclophosphamide, total lymphoid irradiation, mitoxantrone, cladribine, or bone
             marrow transplantation, regardless of duration, will be excluded from participation in
             this study

          -  Systemic corticosteroid therapy within four weeks prior to the first screening
             Magnetic Resonance Imaging (MRI)

          -  Participation in any clinical study, whether or not it involves an investigational
             drug within three months prior to the screening visit

          -  Use of any investigational drug with disease-modifying potential for the treatment of
             multiple sclerosis (MS) within six months of randomization (prior use of
             investigational agents for the symptomatic treatment of MS, e.g., 4-aminopyridine
             (4-AP), may be allowed following discussion with medical monitor

          -  Concomitant statin use in doses exceeding the manufacturers' maximum recommended daily
             dosages for treatment of hypercholesterolemia or as part of an MS disease-modifying
             protocol

          -  Infection or risk factors for severe infections

          -  Excessive immunosuppression or other factors associated with it, including human
             immunodeficiency virus (HIV) infection

          -  Severe, recurrent, or persistent infections [such as Hepatitis B or C, or borreliosis
             or recurrent urinary tract infection (UTI) (> 3 UTIs requiring antibiotic treatment
             per year) or recurrent pneumonia (> 2 pneumonias requiring antibiotic treatment per
             year) or infected decubitus ulcers]

          -  Evidence of current inactive tuberculosis (TB) infection; recent exposure to
             mycobacterium tuberculosis (converters to a positive purified protein derivative
             [PPD]). Subjects with a positive PPD or a chest X-ray suggestive of prior TB infection
             will be excluded

          -  Active tuberculosis disease

          -  Active chronic Lyme disease

          -  Active syphilis

          -  Any other significant infection requiring hospitalization or intravenous (IV)
             antibiotics in the month prior to Screening; or

          -  Infection requiring treatment with antibiotics in the two weeks prior to Screening.

          -  Any of the following risk factors for development of malignancy:

               -  History of lymphoma or leukemia

               -  Cutaneous squamous-cell or basal cell carcinoma (EXCEPT if treated more that two
                  years prior to Screening with evidence of recurrence or residual disease)

               -  Other malignancy (EXCEPT if treated more than five years prior to Screening
                  without evidence of recurrence or residual disease) or

               -  Disease associated with an increased risk of malignancy (such as familial
                  polyposis).

          -  History of major immunologic reaction (such as serum sickness or anaphylactoid
             reaction) to an Immunoglobulin G (IgG) containing agent (such as intravenous (IV)
             gamma globulin, a fusion protein, or monoclonal antibody)

          -  Confounders of the assessment of neurologic response including other diseases that
             produce chronic neurologic manifestations (such as amyotrophic lateral sclerosis,
             Guillain-Barre syndrome, Lyme disease, myasthenia gravis, etc.)

          -  Prior exposure to anti-IL-12 antibodies

          -  Confounders of safety assessment, such as an unstable medical condition not related to
             MS (including those requiring an adjustment of treatment in the four weeks prior to
             Screening)

          -  Exacerbation of asthma requiring hospitalization in the ten years prior to Screening
             (subjects with asthma not requiring hospitalization should be discussed with the
             medical monitor prior to Screening)

          -  Pregnant or lactating females

          -  The following exclusionary laboratory values at screening or baseline:

               -  Hemoglobin (Hgb) <10 g/dL in females or <12 g/dL in males;

               -  White blood cell (WBC) count <3 x 109/L;

               -  Platelet count <100 x 109/L

               -  Serum aspartate transaminase (AST) or alanine transaminase (ALT) x 3 upper limits
                  of normal (ULN);

               -  Serum total bilirubin >/= 3 mg/dL (>/= 51 x mol/L)

               -  Serum creatinine >1.6 mg/dL (> 141 x mol/L)

          -  Subject has a recent history of substance abuse or psychiatric illness that could
             preclude compliance with the protocol

          -  In the eight weeks prior to study drug administration, the subject has received a
             transfusion of any blood product, or has had 500 mL or more of blood removed by
             repetitive or one-time blood donation, plasmapheresis, or plasma exchange, or has lost
             550 mL or more blood because of hemorrhage; or

          -  For any reason, subject is considered by the investigator to be an unsuitable
             candidate to receive ABT-874.