Clinical trial NCT01389895 (phase 1, status: terminated)
Conditions: cutaneous lupus, lupus
ICD codes: D68.62, L93.0, L93.1, L93.2, M32.9, M32.0, M32.11
Drugs: amg 557, amg 557 placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    slow enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, between the ages of 18 and 70 years of age, inclusive, at the time of
             randomization;

          -  Body mass index from 18 to 35 kg/m2 at screening;

          -  Diagnosis of subacute cutaneous lupus erythematosus (SCLE) with or without systemic
             lupus erythematosus (SLE). SCLE as defined by the Gilliam and Sontheimer
             classification (J Am Acad Dermatol 1981; 4(4):471-475). SLE is defined by the most
             recent American College of Rheumatology criteria, including positive antinuclear
             antibodies (ANA) during screening or by documented history (at least 1:80 by indirect
             immunofluorescent assay);

          -  A history of skin biopsy consistent with the diagnosis of SCLE;

          -  Positive SS-A and/or SS-B antibodies at screening;

          -  Intolerance of anti-malarial therapy or ≥ 3 months of anti-malarial therapy with
             residual disease activity as defined by: at least 2 areas with at least level 2
             erythema or 3 areas with at least level 1 erythema using cutaneous lupus erythematosus
             disease area and severity index (CLASI). The total CLASI activity must be ≥ 10;

          -  Subject must have stable disease activity for 3 months prior to screening in the
             clinical judgment of the Principal Investigator (PI) with no anticipated changes in
             therapy;

          -  Stable dose of topical steroids no stronger than medium-potency (Class III or Class
             VII) for ≥ 2 weeks from screening is permitted;

          -  Prednisone ≤ 10 mg/day (or equivalent) is permitted;

          -  Stable doses of methotrexate ≤ 20 mg/week, azathioprine ≤ 150 mg/day, and
             6-mercaptopurine ≤ 150 mg/day for 12 weeks prior to screening are permitted.

          -  Exclusion Criteria:

          -  Drug-induced SCLE;

          -  Any disorder (including psychiatric), condition or clinically significant disease
             (other than a diagnosis of SCLE, SLE, or Sjögren's syndrome) that would, by its
             progressive nature and/or severity, interfere with the study evaluation, completion
             and/or procedures per the investigator's discretion. This includes any age related
             co-morbidities such as presence of congestive heart failure, angina, chronic
             obstructive pulmonary disease, and asthma;

          -  Presence or history of vasculitis (comprising internal organs or extremities or
             leading to peripheral neuropathy) within the last 3 years, presence or history of
             active Central Nervous System (CNS) lupus (defined as seizure disorder, cerebral
             vascular accident, psychosis ascribed to SLE , encephalitis, meningitis, and myelitis)
             requiring therapy within the last 3 years;

          -  History of malignancy;

          -  Signs or symptoms of a viral, bacterial or fungal infection within 30 days of study
             randomization, or recent history of repeated infections;

          -  Underlying condition other than SCLE, SLE, Sjögren's syndrome that predisposes one to
             infections (eg, history of splenectomy);

          -  Administration of >10 mg/day prednisone (or equivalent) in the 30 days prior to
             randomization;

          -  Prior use of any following biological agents: Rituximab, Lymphostat-B, TACl-Ig, and
             CTLA4-Ig;

          -  Current treatment (within 3 months or 5 half-lives of screening) with thalidomide,
             mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, Intravenous (IV)
             immunoglobulin, plasmapheresis, oral or IV cyclophosphamide;

          -  Receiving or has received any investigational drug (or is currently using an
             investigational device) within the 30 days or 5 half-lives (whichever is longer),
             prior to receiving the first dose of study medication).

          -  29. Use of any other over-the-counter or prescription medications within the 14 days
             or 5 half-lives (whichever is longer), prior to receiving the first dose of study
             medication. Acetaminophen (up to 2 g per day) for analgesia and hormone replacement
             therapy (eg, estrogen, thyroid) will be allowed. In addition, prescription drugs for
             hypertension or hypercholesterolemia, oral hypoglycemic drugs, or NSAIDs will be
             allowed; however, NSAIDS are not permitted within 24 hours of skin biopsies to reduce
             the risk of bleeding. Other medications may be approved following review by the
             Principal Investigator and the Amgen Medical Monitor. Written documentation of this
             review and Amgen acknowledgement is required for subject participation;