Efficacy and Safety Results From a Completed Phase 2a Study in Patients With Systemic Lupus Erythematosus Sample Clauses

Efficacy and Safety Results From a Completed Phase 2a Study in Patients With Systemic Lupus Erythematosus. The Phase 2a study (study IP-002) was an open-label, multiple-dose, 12-week study conducted in Bulgaria to evaluate the efficacy and safety of treatment with IPP-201101 in 20 patients with SLE who had elevated anti-dsDNA Ab titers (more than 70 IU/mL by enzyme-linked immunosorbent assay [ELISA]) at study entry. Two dose levels of IPP-201101 (200 and 1000 mcg) were evaluated in 2 cohorts of 10 patients each. Patients were administered 3 sc injections of IPP-201101 (either 200 or 1000 mcg) on study days 1, 15, and 29, with follow-up visits on study days 8, 43, and 57. For the 200-mcg treatment group, long-term follow-up visits were also conducted at months 4, 5, and 6. Study treatment with 1000 mcg was initiated after the planned interim review of the safety data, up to and including day 15, by the Interim Safety Review Board (ISRB) from all patients receiving 200 mcg. In this study, there was a clinically meaningful response for patients who received 2 sc injections of 200 mcg of IPP-201101 on study days 1, 15, and 29, as assessed by decrease in anti-dsDNA Ab levels (7 patients had reductions in anti-dsDNA Ab titer of least 20% at study day 43, and 5 patients had a reduction of at least 20% at study day 57; response was sustained in 3 patients at month 6) and reduction from baseline of at least 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score (6 patients). In the 1000-mcg treatment group, 1 patient had a reduction of at least 20% in anti-dsDNA Ab titer at study day 43 or study day 57. The average value for anti-dsDNA Ab titer was unchanged over the 6-week follow-up period after completion of study treatment in the 1000-mcg treatment group. In addition to the 6 patients in the 200-mcg treatment group who were responders by SLEDAI (defined as a reduction from baseline of at least 4 points in the SLEDAI score), 4 patients in the 1000-mcg treatment group were responders by SLEDAI. Five of the 6 responding patients in the 200-mcg treatment group also had at least a 20% reduction in anti-dsDNA Ab titer, whereas 1 of 4 patients in the 1000-mcg treatment group had both a reduction in SLEDAI score and a reduction in anti-dsDNA Ab titer at study day 57. There were no serious adverse events or withdrawals because of adverse events in the study. Nine (45%) patients experienced a total of 12 adverse events during the course of the study. Adverse events attributed to IPP-201101 treatment were mild dose-related injection site reactions. I...
AutoNDA by SimpleDocs

Related to Efficacy and Safety Results From a Completed Phase 2a Study in Patients With Systemic Lupus Erythematosus

  • Human Leukocyte Antigen Testing This plan covers human leukocyte antigen testing for A, B, and DR antigens once per member per lifetime to establish a member’s bone marrow transplantation donor suitability in accordance with R.I. General Law §27-20-36. The testing must be performed in a facility that is: • accredited by the American Association of Blood Banks or its successors; and • licensed under the Clinical Laboratory Improvement Act as it may be amended from time to time. At the time of testing, the person being tested must complete and sign an informed consent form that also authorizes the results of the test to be used for participation in the National Marrow Donor program.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Technical Standards Applicable to a Wind Generating Plant i. Low Voltage Ride-Through (LVRT) Capability A wind generating plant shall be able to remain online during voltage disturbances up to the time periods and associated voltage levels set forth in the standard below. The LVRT standard provides for a transition period standard and a post-transition period standard.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work.

  • Treatment Program Testing The Employer may request or require an employee to undergo drug and alcohol testing if the employee has been referred by the employer for chemical dependency treatment or evaluation or is participating in a chemical dependency treatment program under an employee benefit plan, in which case the employee may be requested or required to undergo drug or alcohol testing without prior notice during the evaluation or treatment period and for a period of up to two years following completion of any prescribed chemical dependency treatment program.

  • Diagnostic Assessment 6.3.1 Boards shall provide a list of pre-approved assessment tools consistent with their Board improvement plan for student achievement and which is compliant with Ministry of Education PPM (PPM 155: Diagnostic Assessment in Support of Student Learning, date of issue January 7, 2013).

  • Authorized User Overview and Mini-Bid Process Project Based IT Consulting Services Contracts enable Authorized Users to use a competitive Mini-bid Process to acquire Services on an as-needed basis, for qualified IT Projects. Project Based IT Consulting Services may include, but will not be limited to projects requiring: analysis, data classification, design, development, testing, quality assurance, security and associated training for Information Technology based applications. See section 1.3 Out of Scope Work for a listing of projects expressly excluded from the scope of this Contract. An Authorized User Agreement for Project Based IT Consulting Services will be governed first by the terms and conditions specified in the OGS Centralized Contract and second by terms and conditions added to the Authorized User Statement of Work. Additional terms and conditions shall not conflict with or modify the terms and conditions of the OGS Centralized Contract. NYS Executive Agencies must adhere to all internal processes and approvals including, as required, approval from NYS Office of Information Technology Services. Other Authorized Users must adhere to their own internal processes and approvals. In accordance with Appendix B, section 28, Modification of Contract Terms, an Authorized User may add additional required terms and conditions to this Mini-Bid and resultant Authorized User Agreement only if such terms and conditions (1) are more favorable to the Authorized User and (2) do not conflict with or supersede the OGS Centralized Contract terms and conditions. Examples of additional terms and conditions include: • Expedited delivery timeframe; • Additional incentives, such as discount for expedited payment/Procurement Card use; and • Any additional requirements imposed by the funding source or Federal law.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

Time is Money Join Law Insider Premium to draft better contracts faster.