endobj }R��7�kGra5�KO�Թ��EbL;$ѵ�E�,���8��.�|��f��J��$�>y���5KelkM �E�7:,�U;������rl�j6���.K�ېVe?F��L7H��G�&�!�a�r�P�uf��e�%q� Is a healthcare worker or a member of an emergency response team. A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status. Receipt of systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405076.  (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. They aim to learn how a drug is processed in the body and how it affects the body. 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 … <> 3 0 obj Diagnosis of malignancy within previous 10 years (excluding non-melanoma skin cancer). 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. Prior administration of an investigational CoV (eg, SARS-CoV-2, SARS-CoV, MERS-CoV) vaccine. La molécule est testée sur une courte période. Licensed influenza vaccines may be received more than 14 days before or after any study injection. [ 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 ]. Body mass index (BMI) of 18 kg/m2 to 30 kg/m2 (inclusive) at the Screening Visit (Day 0). Is an immediate family member or household member of study personnel. Phase 2b studies are a way to get an early look at whether the vaccine or monoclonal antibody is effective at preventing COVID-19 disease. Phase 0 trials are the first clinical trials done among people. Please remove one or more studies before adding more. 08/28/2020 | Press release | Distributed by Public on 08/28/2020 11:08. <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI] >>/MediaBox[ 0 0 595.5 842.25] /Contents 4 0 R/Group<>/Tabs/S/StructParents 0>> Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment. �'��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����� Phase 2b Clinical Studies. For general information, Learn About Clinical Studies. 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. La durée d’une phase II est généralement de deux à trois ans, dépendant de la pathologie sélectionnée et du nombre de malades. Status: Recruiting Known history of SARS-CoV-2 infection or known exposure to someone with SARS CoV 2 infection or COVID-19. x����� 6�z�#��pW��CkI���3�����������~��Q�, ��P���A�YYY��B�~�{���7/�~�����/vϿ���+�S������Gj���j�G�*��ϰ����#��Z3������O�;��Ǐ~���}�O�����7/v;1���yL?�Z��[�h�H��Hl׷�oAb������o}$�/C9��˱��Կ�q�� Read the full description here. Participants meeting this criterion may be rescheduled within the relevant window periods. Anticipating the need for immunosuppressive treatment at any time during participation in the study. Has received or plans to receive a licensed vaccine ≤ 28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis History of illegal substance use or alcohol abuse within the past 2 years. Why Should I Register and Submit Results? Current treatment with investigational agents for prophylaxis against COVID-19. 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. Cette phase ne concerne qu’un nombre limité de personnes et sur une période courte de traitement. Understands and agrees to comply with the study procedures and provides written informed consent. For more information about Akcea clinical trials, please contact us at research@akceatx.com. 1 0 obj Share your location or enter your city or zip code to find studies near you. History of anaphylaxis, urticaria, or other significant AR requiring medical intervention after receipt of a vaccine. endobj 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).. Biological: Biological: mRNA-1273: 50 mcg, Biological: Biological: mRNA-1273: 100 mcg. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator. Groups: Adults aged 18-54 years Dose: 50 mcg Intervention: Biological/Vaccine: mRNA-1273 50 mcg, Groups: Adults aged 55+ years Dose: 50 mcg Intervention: Biological/Vaccine: mRNA-1273 50 mcg, Groups: Adults aged 18-54 years Dose: 100 mcg Intervention: Biological/Vaccine: mRNA-1273 100 mcg, Groups: Adults aged 55+ years Dose: 100 mcg Intervention: Biological/Vaccine: mRNA-1273 100 mcg. La première fois qu'un nouveau traitement ou vaccin est testé chez l'Homme, il est généralement administré à un petit groupe de volontaires en bonne santé. L’étude clinique de phase 2 est une étude qui évalue l’efficacité clinique d’une molécule, et détermine ses éventuels effets secondaires. Choosing to participate in a study is an important personal decision. Positive serology for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) type 1 or 2 antibodies identified at the Screening Visit (Day 0). Toutefois, dans certains cas, par exemple lorsqu'un nouveau médicament est testé pour le traitement d'une maladie terminale comme le cancer, il peut être testé chez des volontaires malades. Topical tacrolimus is allowed if not used within 14 days prior to the Screening Visit (Day 0). 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. The Clinical Scientist is responsible for medical writing activities at Innovaderm. Symbol ALBPS Inclusion of the first patient in Abivax's Phase 2b (ABX464-103) clinical trial for the treatment of hemorrhagic rectocolitis August 19, 2019 The main evaluation criterion is … The Kaplan–Meier curves for the time to intubation or death are shown in Figure 2A. 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 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 agreed to continue adequate contraception through 3 months following the second injection (Day 29). COVID-19 is an emerging, rapidly evolving situation. Male participants with partners who have become pregnant prior to Screening are eligible to participate in the study. L'objectif est Biomedical Advanced Research and Development Authority. �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$L�e���L@��βG��G�����(] gb�pW����,0�ତN����꒶0p��1 3��y�Lr���x�;�@��r�HR�� PZ��փ&)��'�T�{ �����P ��XWmz��*a�G���P����h��D�ݙ�#xKr��_5\���Q;�ۏ���:��;��wdz�6�׽�#\h���0��,,�'��2&P�o�.���Æ����F����h�I&��s�z`��A�d��z�W�J�A����ߡn�����@ޒ�L�����Dx1'�A��g��|�zGNg���Q]��`�D8���I�(A`W��k�YJ^�������;tm�ݯ�`�' 5�ug���#?��07��o �����Wn���rN�x.�I�A��fׂ�FWL���UC�R��B��q|�!�:�E���e Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (Day 1). Les principaux objectifs de la phase I sont les suivants : 1. vérifier que le nouveau médicament ne présente aucun problème de sécurité majeur ; 2. démontrer qu'il … Female participants of nonchildbearing potential may be enrolled in the study. �]ú�aY*���_��$?4V��(}Њ�W9�Ksp���-���2@���5��2G�Y Search for Clinical Trials by condition, keyword or trial number. %���� Read our, ClinicalTrials.gov Identifier: NCT04405076, Interventional 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Fever is defined as a body temperature ≥ 38.0°C/100.4°F. 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. 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). 1. 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. Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer either from below the limit of detection (LOD) or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers. History of chronic smoking (≥ 1 cigarette a day) within 1 year of the Screening Visit (Day 0). Current or previous diagnosis of immunocompromising condition, immune-mediated disease, or other immunosuppressive condition. Talk with your doctor and family members or friends about deciding to join a study. <>>> n~��w �FϳEa4ĥ%�4�s����i���h�/��I�E �H�y2��D Ils ne permettent pas de connaître tous les effets indésirables d’un médicament, en particulier les effets indésirables rares (<1/1000 ou 1/10 000 voire moins) du fait du nombre limité de patients inclus. 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. endobj Travel outside of the US in the 28 days prior to the Screening Visit (Day 0). Certains essais de phase II comparent deux traitements. 4 0 obj 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. %PDF-1.5 To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Has a negative pregnancy test at Screening (Day 0) and on the day of the first injection (Day 1). Bleeding disorder considered a contraindication to IM injection or phlebotomy. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Solicited local and systemic adverse reactions (ARs) [ Time Frame: 7 days post-vaccination ], Unsolicited adverse events (AEs) [ Time Frame: 28 days post-vaccination ], Medically-attended adverse events (MAAEs) [ Time Frame: Month 0 through Month 13 ], Serious adverse events (SAEs) [ Time Frame: Month 0 through Month 13 ], Change in the measure of clinical safety laboratory values in Cohort 2 from baseline [ Time Frame: Through 1 month after last vaccination ], The number and percentage of participants with abnormalities in blood pressure, temperature, HR or respiratory rate will be assessed. Avec des résultats positifs de l’essai clinique Lupus Phase 2a, nous envisageons la Phase 2b complémentaire. Known history of hypotension or systolic blood pressure < 85 mm Hg at the Screening Visit (Day 0). �:�.��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�� Ces volontaires peuvent être indemnisés. La phase 2 correspond à la première administration de la molécule chez des malades. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). β��z�HA@�\ee&��Wɕ]']cݻ�! Essai clinique fermé ... GSK3359609 combination therapy with Part 2A pembrolizumab combination dose escalation phase/safety run-in and Part 2B cohort expansion phase. Find a Trial. We have initiated a Phase 2b study to evaluate the safety and efficacy of different doses and dose intervals of AKCEA-APOCIII-L Rx in approximately 100 patients with hypertriglyceridemia and established cardiovascular disease (CVD). Male or female, 18 years of age or older at the time of consent (Screening Visit, Day 0). Monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above). Ces essais de phase III ont une durée prolongée par rapport aux essais de phase II. stream 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. In these trials, a very small dose of a drug is given to about 10 to 15 people. According to the assessment of the investigator, is in good general health and can comply with study procedures. L’étude de Phase 2b est menée afin d’évaluer l’efficacité et la tolérance de trois doses différentes d’ABX464, prises par voie orale une fois par jour par des patients atteints de la rectocolite hémorragique modérée à sévère. La phase 2 est subdivisée en deux phases : phases 2a et 2b. Une nouvelle augmentation de capital à hauteur de 200 K€ est en cours pour soutenir la préparation des phases cliniques : Lupus 2b et Réaction du Greffon contre l’Hôte (GvHD). Les essais de Phase 2 sont menés sur un petit groupe homogène de volontaires atteints de la maladie ciblée. Les essais cliniques de Phase 2b dans la rectocolite hémorragique . 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 Phase 2 Première administration chez les malades . 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). 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). A randomized Double-blind, Placebo-controlled First-in-Human, Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Monovalent HPV16 and HPV18 Ad26-vectored Vaccine Components and an MVA-vectored HPV16/18 Vaccine Component in Otherwise Healthy Women with HPV16 or 18 Infection of the Cervix. ISN FR0012816825 Market Euronext Growth. Epilepsy linked to the EFHC1 gene and Charcot-Marie-Tooth type 2A, a peripheral neuropathy caused by mutations in the mitofusin 2 gene. Les essais de phase II, ont pour objectif de confirmer l’activité clinique préliminaire et/ou pharmacologique du médicament à la dose recommandée à l’issue de la phase I. Un nombre limité de malades est inclus dans ces essais (40 à 80 en moyenne). 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. 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. An Open-Label, Phase 2a/2b Study of KRT-232 in Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post-ET-MF) Who Have Failed Ruxolitinib. 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. 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. Deux étapes composent cette seconde phase (phase 2a et phase 2b). 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. Pour en savoir plus, lire Les essais de phase précoce aux pag… <> GSK3359609 combinations with chemotherapy will only consist of safety run-in cohorts. fj��D���� Ā��\�%�[Q�%�,J�\֌�� ��o��PT#%�tf�V:�S� �@F:E �M�R����^�#D�ńD���p�)��j��*�Dh��0� b��#s�4 6�I���!o����M� b#�XF�nrY�C� �K�l�G�&��n-�2n?+v���Y`�JEܳ�Y%u�. 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: Actual Study Start Date : May 29, 2020: Estimated Primary Completion Date : March 2021: Estimated Study Completion Date : August 2021 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 use of any inhaled substance (eg, tobacco or cannabis smoke, nicotine vapors). 2 0 obj They are sometimes known as Proof of Concept or Test of Concept studies.