Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus
Brief Summary: To evaluate the efficacy and safety of sifalimumab compared to placebo in subjects with moderately to severely active Systemic Lupus Erythematosus (SLE).


Options:
A: Inclusion Criteria:

* Diagnosis of cutaneous lupus erythematosus (CLE, including subacute cutaneous lupus erythematosus, discoid lupus erythematosus, or lupus erythematosus tumidus) or systemic lupus erythematosus (SLE)

  * Had a body weight less than or equal to 100 kg
  * Patients in Part A who were taking systemic medications for CLE had to be on a stable dose for 4 weeks before the first study agent infusion
  * Patients in Part B taking systemic medications for SLE had to be on a stable dose for at least 3 months before the first study agent infusion
  * Given informed consent and willing and able to adhere to the study visit schedule and other protocol requirements; agreed to avoid alcohol intake; and took adequate measures to prevent pregnancy

Exclusion Criteria:

* Significant history of or concurrent medical condition (other than lupus)
* Use of specific previous or concurrent medications or investigational therapies
* Known or suspected allergy to the study agent or it constituents, having recently donated blood, or having any significant laboratory test values requiring intervention
* Patients with SLE in Part B could not have active central nervous system lupus
B: Inclusion Criteria: - Fulfills at least 4 of American College of Rheumatology (ACR) criteria for systemic lupus erythematosus (SLE) including a positive antinuclear antibody (ANA) or elevated ds-deoxyribonucleic acid (DNA) or Sm antibody at screening - Disease history of SLE greater than or equal to (\>=) 24 weeks at screening - Weight more than (\>) 40 kilogram (kg) - Currently receiving stable dose of oral prednisone and/or antimalarials/immunosuppressives - Active moderate to severe SLE disease based on SLE disease activity score (SLEDAI) and British Isles Lupus Assessment Group Index (BILAG) and Physicians Global Assessment - No evidence of cervical malignancy on PAP within 6 months of randomization - Female subjects must be willing to avoid pregnancy - Negative TB test or newly positive TB test due to latent TB for which treatment must be initiated at or before randomization. Exclusion Criteria: - Active severe SLE-driven renal disease or unstable renal disease prior to screening - Active severe or unstable neuropsychiatric SLE - Clinically significant active infection including ongoing and chronic infections - History of human immunodeficiency virus (HIV) - Confirmed Positive tests for Hepatitis B or positive test for hepatitis C - History of severe herpes infection such as herpes encephalitis, ophthalmic herpes, disseminated herpes - Herpes Zoster within 3 months of screening - History of cancer other than basal cancer or cervical cancer treated with apparent success \>=1 year prior to randomization - Receipt of a biologic agent within 5 half-lives or prior to loss of pharmacodynamic and/or clinical effect (whichever is longer) prior to screening - Live or attenuated vaccine within 4 weeks prior to screening - Subjects with substance abuse - Subjects with significant hematologic abnormalities.
C: Inclusion Criteria:

* Subjects must understand and voluntarily sign Informed Consent and HIPAA forms.
* Males and females over the age of 18 at the time of signing informed consent form.
* Able to adhere to the study visit schedule and other protocol requirements
* Subjects must have biopsy proven Cutaneous Lupus Erythematosus (CLE) either in the form of Discoid Lupus Erythematosus (DLE) or Subacute Lupus Erythematosus (SCLE), with or without systemic involvement.
* Subjects must have grade II erythema in at least three skin locations as defined by the Cutaneous Lupus Activity and Severity Index (CLASI).
* Subjects must have failed standard treatment with hydroxychloroquine (Plaquenil) for up to three months.
* Female subjects who are not pregnant.
* Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional method AT THE SAME TIME, at least 28 days before starting to take lenalidomide (Revlimid®). FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
* If pregnancy or a positive pregnancy test is noted in a study subject or in the partner of a male study subject during study participation, the study drug must be discontinued immediately.

Exclusion Criteria:

* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
* Female subjects who are pregnant, plan to be pregnant during the study, or who are breastfeeding.
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk for study participation, or confounds the ability to interpret data from the study.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Known hypersensitivity to thalidomide.
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Prior history of deep vein thrombosis (DVT).
* Prior history of pulmonary embolus (PE).
* Known positive for HIV viral DNA by qPCR.
* Positive hepatitis B surface antigen, or hepatitis C.
* Platelet count \< 50,000/mcL.
* Absolute neutrophil count \< 750/mcL
* Lymphopenia \< 500/mcL.
* Have current signs or symptoms of severe progressive or uncontrolled renal disease (creatinine ≥1.5 x ULN).
* If female, unwillingness to use one highly effective method and one additional method of birth control.
* If male, unwillingness to use a latex condom during intercourse with females of childbearing potential.
* Continued therapy with thalidomide.
D: Inclusion Criteria:

* Diagnosis of SLE by American College of Rheumatology guidelines.
* On stable SLE treatment
* Active SLE disease
* Serologically active
* 18 years of age or older
* Receiving stable doses of prednisone between 7.5 mg and 40 mg per day

Exclusion Criteria:

* Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension, or uncontrolled diabetes.
* Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C.
* Liver disease.
* Anemia, neutropenia, or thrombocytopenia.
* Malignancy within past 5 years
* Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections.
* History of active tuberculosis or a history of tuberculosis infection.
* Participation in the active treatment arm of any Phase 2 or Phase 3 clinical trial for a molecule that primarily targets the B cell pathway in the past 18 months.
* Prior administration of any B cell depleting therapy in the past 18 months.
* Pregnant or nursing
* History of congenital immunodeficiency

Answer: B