A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01470313
• Date of registration: 09/11/2011
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus
• Scientific title: A Randomized, Subject And Investigator-Blinded (Sponsor-Open), Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Preliminary Efficacy Of Multiple Ascending Doses Of PD- 0360324 In Subjects With Active Cutaneous Lupus Erythematosus (CLE)
• Date of first enrolment: November 2011
• Target sample size: 28
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01470313
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Canada, Moldova, Republic of, Singapore, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and/or female subjects between the ages of 21 to 70 who have a clinical
diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus
erythematosus with or without systemic lupus erythematosus prior to screening that
has been confirmed by evaluation of skin biopsy sample.

- Active disease at both screening and baseline (Day 1) defined by a CLASI score of
greater than or equal to 10.

- Intolerance to antimalarial therapy or more than 3 months of antimalarial therapy
with disease activity.

Exclusion Criteria:

- Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months
of Day 1.

- Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic
infection, or recent history of repeated infections

- Subjects with evidence of past or active tuberculosis

- Pregnant, planning to get pregnant, and/or lactating females or males planning to
father a child within time period of the study or subsequent exclusionary period.



Age minimum: 21 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cutaneous Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: PD-0360324

Primary Outcome(s)

Safety and tolerability of PD- 0360324 will be assessed by physical examinations, adverse event and infection monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements. [Time Frame: 16 Weeks]

Secondary Outcome(s)

Assess health outcomes measures [Time Frame: 12 Weeks]

Measure changes in biomarkers [Time Frame: 12 weeks]

Efficacy of PD-0360324 based upon reduction of severity of symptoms as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [Time Frame: 12 Weeks]

Evaluate the Pharmacokinetics of PD-0360324 [Time Frame: 16 Weeks]

Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) [Time Frame: 12 Weeks]

Secondary ID(s)

A6261008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors