Placebo. Sponsor shall be responsible for the Manufacture and supply of placebo, comparator products and diagnostic products, in each case, as applicable and to the extent set forth in the applicable Study Plan; provided that, except as otherwise set forth in a Study Plan, Regeneron shall be responsible for the Manufacture and supply of placebo and diagnostic products for the Regeneron Product. The provisions of this Article 9 applicable to the supply of Product shall also apply to any such placebo or comparator product.
Placebo. Participants randomised to Group 2 will receive a placebo injection of 0.9% saline (sourced by Xxxxxx Clinical Services) instead of MVA-NP+M1. Each vial of saline will only be used for a single participant.
Placebo. Placebo vials matching the single-dose vials of IPP-201101 will be supplied by ImmuPharma. Each vial contains a white to off-white, amorphous powder as a lyophilized sterile formulation of mannitol (and acetic acid used for pH adjustment, if necessary). Before reconstitution, vials of placebo must be stored under refrigerated conditions (2° to 8° C [36° to 46° F]) in a secure place and protected from light. The study center will receive box(es) with up to 13 vials per box. Each vial will be labeled with a 4-digit treatment number and each box will contain placebo vials. Prior to administration, placebo should be reconstituted with 1.1 mL sterile water for injection (volume of injection of 1.1 mL). After reconstitution, the vial can be stored at controlled room temperature (20° to 25° C [68° to 77° F]) for up to 2 hours prior to administration and does not need to be protected from light. Patients randomly assigned to placebo will be administered placebo sc every 4 weeks for 48 weeks (a total of 13 doses will be administered). Method of Blinding: Patients will be randomly assigned to treatment through a qualified randomization service provider (eg, interactive response technology [IRT]). Patients and investigators will remain blinded to treatment assignment during the study. Study drug may not be administered by the same individual performing the SLEDAI- 2K, BILAG-2004, or PhGA. Study drug should be administered at each study visit after all study visit procedures and assessments have been completed.
Placebo. Minimal dose Low dose Medium dose High dose 400mg every 4 weeks (Q4W) 800mg every 4 weeks (Q4W) 800mg every 2 weeks (Q2W) 1200mg every 2 weeks (Q2W) placebo Q2W 40.0% 51.5% 38.7% 45.5% 47.1% A statistically significant reduction of the dermatology life quality index, or DLQI, could be detected comparing the overall treatment arms with the placebo arm at week 16 (p=0.031). The median DLQI reduction at week 16 compared to pre-dose values was highest in the medium dose group (-5.5 points) when compared to the reduction in the placebo group (-1.5 points). There was a trend in the reduction of the overall AN count comparing the placebo group (median reduction of -3.0) and the low, medium and high dose group (-5.0, -5.0, and -4.5, respectively). IFX-1 was well tolerated. No difference could be detected in treatment emergent adverse events between placebo and treatment groups. Overall, 72% of placebo treated patients experienced a treatment emergent adverse event when compared to 66% of the combined IFX-1 treated groups. The most common treatment emergent adverse events were exacerbation of HS and nasopharyngitis. On July 18, 2019, we published a post-hoc analysis. This analysis showed multiple additional signals of efficacy for the IFX-1 high dose group compared to the placebo group within the initial phase of the SHINE study, which demonstrated significant reductions in all combined inflammatory lesions, on draining fistula and on the International Hidradenitis Suppurativa Severity Score 4, or IHS4, which also scores all inflammatory lesions and has been developed by an international expert group to score severity and track treatment response, although it has not been utilized in late stage clinical studies in HS. The IHS4 weights the most fluctuating lesions such as inflammatory nodules (1 point), less than abscesses (2 points) or draining fistulas (4 points). At week 16, there was a statistically significant reduction of draining fistulas, or DF, relative to baseline in the high dose IFX-1 group when compared to placebo (Figure 1 – relating to all patients with at least 1DF at baseline). Figure 1: DF reduction relative to baseline at week 16 (left: Mean, right: Median) in all patients with at least 1 draining fistula at baseline. For mean comparisons and the p-value of high dose versus placebo, an ANCOVA model adjusted for DF and Xxxxxx stage at baseline was calculated. The p-value for the median comparison of high dose versus placebo was based on the Wilcoxo...
Placebo. Placebos (in appropriate studies) will be manufactured using the same excipients as the active tablets. Premix comprised of [**] and [**]. Additional inactive excipients: microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate are blended with [**] to match active tablets. All excipients used in the manufacture of the placebo tablets are of compendial grade and/or pharmaceutical quality. None of the excipients used in the manufacture of the drug product are novel or have animal or human origin. SCHEDULE 2.1 Overview Plan [**] Confidential SCHEDULE 10.2.2 Karyopharm Patent Coverage as of May 18, 2018 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 3 pages were omitted. [**]
Placebo. Provide matching placebo in sufficient quantities to supply MGH throughout the course of the Regimen Study. Packaging and labeling is the responsibility of MGH’s ALS Platform Trial Central Pharmacy vendor unless otherwise determined by the Company. Company shall ship drug directly to MGH’s ALS Platform Trial’s Central Pharmacy vendor for distribution to Study Sites in an appropriately temperature-controlled manner as specified by the Company.
Placebo. Formulation and specifications without the Active Principle, as specified in accordance with the specifications for Placebo attached hereto as Annex 2.
Placebo. During this study there is a XX chance that you will receive a placebo. HIV Testing: Research procedures include testing for HIV. For studies that involve Whole Genome Sequencing (WGS): Make clear in the consent form that WGS will be included as a research procedure. Include a description of WGS such as; WGS is the sequencing of a human germline or somatic biospecimen with the intent to generate the complete DNA sequence of that biospecimen. After you complete the main part of the study...
Placebo. During this study you could receive placebo. This could lengthen the amount of time before you receive a treatment that may be effective. During this time you may experience worsening of your condition, including increased symptoms such as [XX]. The researchers will carefully monitor your condition. If your symptoms worsen and make you uncomfortable, you can withdraw from the study. Blood draw: Removing blood by a needle may cause temporary pain, bruising, bleeding, swelling, dizziness, and on rare instances fainting or infection. Exercise testing: The exercise test may cause muscle soreness, dizziness, or shortness of breath. In rare instances, exercise tests may cause chest pain, tightness, or a change in xxxxx xxxxx. Psychological discomforts: Some of the procedures may cause embarrassment or anxiety, or the questions the researchers ask you may be upsetting or make you uncomfortable. If you do not wish to answer a question, you can skip it and go to the next question. If you do not wish to participate you can stop. HIV testing: Being tested for HIV may make you feel nervous or anxious about the test results. A positive test indicates that you have been infected with the HIV virus, but no one knows for certain when, if ever, you will become sick with AIDS or a related condition. Receiving positive results may make you very upset. If other people learn about your positive test results, you may have trouble obtaining insurance or employment. To the extent permitted by law, the researchers will keep your test results confidential and will not release them to anyone without your written permission. If you test positive, California law requires health care providers and clinical laboratories to report the HIV test results with your personal identifying information to the local health department.
