Phase Ib Study of SC Milatuzumab in SLE

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2021
• Main ID: NCT01845740
• Date of registration: 17/04/2013
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Phase Ib Study of SC Milatuzumab in SLE
• Scientific title: A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: January 2007
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01845740
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: William Wegener, PhD, MD
• Affiliation: Gilead Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female = 18 years old

- Signed written informed consent before study entry

- Diagnosis of SLE by American College of Rheumatology revised criteria (meets = 4
criteria)

- Positive ANA (titer = 1:80) at study entry

- At least 1 BILAG A or 2 BILAG B scores in any organ/body system and = 6 SELENA-SLEDAI
score

- Receiving at least 5.0 mg/day oral prednisone (or equivalent) at stable doses for at
least 4 weeks prior to study entry

- If receiving immunosuppressives or antimalarial agents, at stable doses for at least 4
weeks prior to study entry

Exclusion Criteria:

- Pregnant or lactating women. Women of childbearing potential must have a negative
pregnancy test.

- Women of childbearing potential and fertile men not practicing or unwilling to
practice birth control during the study

- Rituximab, belimumab, other prior antibody, investigational or experimental therapy
within 6 months

- Allergic to murine, chimeric, humanized or human antibodies

- Hematologic abnormalities not attributed to lupus: hemoglobin < 8.0 mg/dL, WBC <
2000/L, ANC < 1500/L, platelets < 50,000/L,

- AST, ALT or alkaline phosphatase > 3 times upper limit of normal and not attributed to
lupus

- Serum creatinine > 2.5 mg/dL, proteinuria > 3.5 g/day

- Received live vaccine within 4 weeks

- Thrombosis, spontaneous or induced abortion, stillbirth or live birth within 4 weeks

- Antiphospholipid antibodies AND a history of thromboembolic events

- On oral anticoagulants (not including NSAIDs) within 4 weeks

- Active infection with antibiotics within 7 days

- Infection requiring hospitalization or herpes zoster treatment within 4 weeks

- Long-term infectious diseases (tuberculosis, fungal infections) active within 2 years

- Malignancy (except squamous or basal cell carcinoma, cervical CIS) within 3 years
(unless approved by the medical monitor)

- History of recurrent abortions (2 or more)

- Known HIV, hepatitis B or C, other immunosuppressive states

- Other concurrent medical conditions that, in the investigator's opinion, could affect
the patient's ability to tolerate or complete the study will not be eligible for the
study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Lupus Vasculitis, Central Nervous System

Lupus Erythematosus, Cutaneous

Lupus Erythematosus, Discoid

Lupus Erythematosus, Systemic

Intervention(s)

Drug: milatuzumab

Drug: Placebo

Primary Outcome(s)

Obtain preliminary evidence of efficacy for patients with active disease. [Time Frame: up to 2 years]

Safety and Tolerability [Time Frame: up to 2 years]

Secondary ID(s)

IMMU-115-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

United States Department of Defense