Travel outside of the US in the 28 days prior to the Screening Visit (Day 0). History of chronic smoking (≥ 1 cigarette a day) within 1 year of the Screening Visit (Day 0). Bleeding disorder considered a contraindication to IM injection or phlebotomy. �V��t E�*�m_��m3���(�?kJ��;oT�����wm7A0���+�������N�����:�uߟ;�����v�9N�/���nSA�9.� K�> �_4=l�p��F���� �e.�n����\�Y,0@+��G�ϗ����,ٺ@� ��U�焈�BG�N邉�B̽S��aRI����u���~�)&?�J"n����9����`p7�ٿv���x��^��0�]����l��� /�~��V��� -����m����� �� e�D��Q��m;���K���G�3l[ Ȑ�v�$���X"����b�-��=���w8���7�w�� A?5�F|���uh�� f=��_�_���.���37�|�C_N��;QZi��h;�qI%�06���2Ƚ��ܸ������ �Uc���E�kd$L�e���L@��βG��G�����(] gb�pW����,0�ତN����꒶0p��1 3��y�Lr���x�;�@��r�HR�� PZ��փ&)��'�T�{ �����P ��XWmz��*a�G���P����h��D�ݙ�#xKr��_5\���Q;�ۏ���:��;��wdz�6�׽�#\h���0��,,�'��2&P�o�.���Æ����F����h�I&��s�z`��A�d��z�W�J�A����ߡn�����@ޒ�L�����Dx1'�A��g��|�zGNg���Q]��`�D8���I�(A`W��k�YJ^�������;tm�ݯ�`�' 5�ug���#?��07��o �����Wn���rN�x.�I�A��fׂ�FWL���UC�R��B��q|�!�:�E���e <> Biophytis - Approbation par la FDA et l'AFMPS de l'amendement apporté au protocole de SARA-INT, essai clinique de phase 2b sur Sarconeos (BIO101) dans la sarcopénie 11 Feb 2020 08:00 CET Company Name BIOPHYTIS. β��z�HA@�\ee&��Wɕ]']cݻ�! <> Cette phase ne concerne qu’un nombre limité de personnes et sur une période courte de traitement. Known history of SARS-CoV-2 infection or known exposure to someone with SARS CoV 2 infection or COVID-19. 08/28/2020 | Press release | Distributed by Public on 08/28/2020 11:08.  (Clinical Trial), A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older, Experimental: mRNA-1273: Dose 50 mcg - Adults Aged 18-54, Experimental: mRNA-1273: Dose 50 mcg - Adults Aged 55+ years, Experimental: mRNA-1273: Dose 100 mcg - Adults Aged 18-54, Experimental: mRNA-1273: Dose 100 mcg - Adults Aged 55+ years, 18 Years and older   (Adult, Older Adult), Kansas City, Missouri, United States, 64114, Wilmington, North Carolina, United States, 28403, Dakota Dunes, South Dakota, United States, 57049. 3 0 obj History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine. Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the Screening Visit (Day 0) (for corticosteroids ≥ 20 mg/day of prednisone equivalent). Ces volontaires peuvent être indemnisés. Phase 2 Première administration chez les malades . In the Phase 2B/3 study, AB07002, conducted in 301 patients, masitinib at a dose of 4.5 mg/kg/day slowed disease progression in patients, which was the study’s primary objective. Study record managers: refer to the Data Element Definitions if submitting registration or results information. La durée d’une phase II est généralement de deux à trois ans, dépendant de la pathologie sélectionnée et du nombre de malades. Information provided by (Responsible Party): This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older. Male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. n~��w �FϳEa4ĥ%�4�s����i���h�/��I�E �H�y2��D Biophytis fait le point sur l’état d’avancement de SARA-INT, un essai clinique de phase 2b évaluant l’efficacité de Sarconeos (BIO101) dans le traitement de la sarcopénie. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. �:�.��Z}�' %A'�&q�!1�@P��c�|�����0��]/���~��oФw�,Q��4���A(� �Bp�4�U��u|}�n�Z`O|Z�Ad@t��q�+1�-�#�L�{�eK���fS�fCPk\�KZW�u\�fQI]�H%�PR������$p�6=�1�A��n!G\]¤HP�� Each participant must meet all of the following criteria during the screening period and at Day 1, unless noted otherwise, to be enrolled in this study: Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. Has agreed to continue adequate contraception through 3 months following the second injection (Day 29). The individual will author or contribute to development of clinical and regulatory documents (synopsis, study protocols, statistical analysis plans, clinical study reports), as well as scientific … La phase 2 correspond à la première administration de la molécule chez des malades. Prior administration of an investigational CoV (eg, SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine. 1. Licensed influenza vaccines may be received more than 14 days before or after any study injection. The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. In these trials, a very small dose of a drug is given to about 10 to 15 people. Essai Clinique Généré le 13 mai 2020 à partir de Titre A Multicenter Phase 1/2b Study of the Bruton's Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination With Carfilzomib (Kyprolis™) in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma Protocole ID PCYC-1119-CA ClinicalTrials.gov ID NCT01962792 Body mass index (BMI) of 18 kg/m2 to 30 kg/m2 (inclusive) at the Screening Visit (Day 0). Read the full description here. Current treatment with investigational agents for prophylaxis against COVID-19. For general information, Learn About Clinical Studies. Share your location or enter your city or zip code to find studies near you. Essai clinique fermé ... GSK3359609 combination therapy with Part 2A pembrolizumab combination dose escalation phase/safety run-in and Part 2B cohort expansion phase. Les essais de Phase 2 sont menés sur un petit groupe homogène de volontaires atteints de la maladie ciblée. Current use of any inhaled substance (eg, tobacco or cannabis smoke, nicotine vapors). Biomedical Advanced Research and Development Authority. Certains essais de phase II comparent deux traitements. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405076. Diagnosis of chronic pulmonary disease (eg, chronic obstructive pulmonary disease, asthma), Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening Visit (Day 0). Symbol ALBPS This exclusion does not apply to historical cannabis use that was formerly illegal in the participant's state but is legal at the time of Screening. A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status. For more information about Akcea clinical trials, please contact us at research@akceatx.com. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. La molécule est testée sur une courte période. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening (Day 0) without an alternative medical cause). Participants meeting this criterion may be rescheduled within the relevant window periods. Communiqué de presse Biophytis fait le point sur l'état d'avancement de SARA-INT, un essai clinique de phase 2b évaluant l'efficacité... | August 30, 2020 Has donated ≥ 450 mL of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study. Sterilization of a female participant's monogamous male partner prior to entry into the study Note: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. According to the assessment of the investigator, is in good general health and can comply with study procedures. COVID-19 is an emerging, rapidly evolving situation. L'objectif est %PDF-1.5 For example: Adequate contraception for male participants is defined as: Participants meeting any of the following criteria at the Screening Visit (Day 0) or at Day 1, unless noted otherwise, will be excluded from the study: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide, Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route. Listing a study does not mean it has been evaluated by the U.S. Federal Government. The Kaplan–Meier curves for the time to intubation or death are shown in Figure 2A. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Epilepsy linked to the EFHC1 gene and Charcot-Marie-Tooth type 2A, a peripheral neuropathy caused by mutations in the mitofusin 2 gene. Les différentes phases en recherche clinique Phase IIIa • Essais sur le médicament non encore commercialisé Phase IIIb • Essais sur le médicament commercialiséen vu d’une demande d’extension de l’AMM (pour ses effets dans une autre pathologie par exemple) DU IRC - TEC / Session 2011-2012 - Cours du 04/11/2011 Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study. Participated in an interventional clinical study within 28 days prior to the Screening Visit (Day 0) or plans to do so while participating in this study. Pour en savoir plus, lire Les essais de phase précoce aux pag… <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.5 842.25] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Search for Clinical Trials by condition, keyword or trial number. [ Time Frame: Through 1 year after last vaccination ], The number and percentage of participants with abnormalities in physical examinations will be assessed [ Time Frame: Through 1 year after last vaccination ], Evaluate immunogenicity of mRNA-1273 by titer of SARS-CoV-2-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: Through 1 year after the final dose ], Titer of SARS-CoV-2-specific neutralizing antibody (nAb) [ Time Frame: Through 1 year post last vaccination ], Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer [ Time Frame: Through 1 year post last vaccination ]. 2 0 obj Les principaux objectifs de la phase I sont les suivants : 1. vérifier que le nouveau médicament ne présente aucun problème de sécurité majeur ; 2. démontrer qu'il … In addition, this is the first time that therapeutic apheresis was used in a phase 2b/3 trial on AD, 31 including a new form, LVPE, aimed at chronic diseases. Known history of hypotension or systolic blood pressure < 85 mm Hg at the Screening Visit (Day 0). 6�I���!o����M� b#�XF�nrY�C� �K�l�G�&��n-�2n?+v���Y`�JEܳ�Y%u�. Is an immediate family member or household member of study personnel. �'��y��A~�nk�i�Pr�Z=���9��ӕc=��N1����5�y܈d�p����(�ߒ���,�*NT{�J��n���GU�~�R�\;j�V�@��_���ܴ����ޢ�\���Ά�h��`�������*.���-�(B�q�W�6r!�.y�}��EB+|�'�p�~0-�|���e/F�~ j������aq���ٱ�l�b�-�qt2��hb�(T8|a0Y��;Ͻ�{��g��&�^4�(�M�Er�g�{�t�զ�T(�#�u���o�X&��K2���+�DۿcJ�w�uf���XZ�#j�o7\�á��{�q�����2h����� They are sometimes known as Proof of Concept or Test of Concept studies. Les essais cliniques de Phase 2b dans la rectocolite hémorragique . Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis endobj Has a negative pregnancy test at Screening (Day 0) and on the day of the first injection (Day 1). Find a Trial. Understands and agrees to comply with the study procedures and provides written informed consent. Monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above). Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1). They aim to learn how a drug is processed in the body and how it affects the body. Phase 2b Clinical Studies. 1 0 obj Female participants of nonchildbearing potential may be enrolled in the study. Please remove one or more studies before adding more. Un essai clinique se déroule en plusieurs étapes ou phases : Phase I Cerner la toxicité de traitement A ce stade, les essais sont menés principalement sur un nombre limité de sujets sains (10 à 40), sous strict contrôle médical. Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition. Known history of hypertension, or systolic blood pressure > 150 mm Hg in participants in Cohort 1 (≥ 18 to < 55 years old) or systolic blood pressure > 160 mm Hg in participants in Cohort 2 (≥ 55 years old) at the Screening Visit (Day 0)..