CALYX

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itemtype="http://schema.org/ListItem"><a itemprop="item" class="home" href="/"><span itemprop="name" class="dnone">Home</span></a><meta itemprop="position" content="0"/></span><i class="fa fa-angle-right" aria-hidden="true"></i> <span itemprop="itemListElement" itemscope="" itemtype="http://schema.org/ListItem"><a itemprop="item" title="Clinical Studies" href="/clinical-studies/"><span itemprop="name">Clinical Studies</span></a><meta itemprop="position" content="1"/></span> <i class="fa fa-angle-right" aria-hidden="true"></i></span><span itemprop="itemListElement" itemscope="" itemtype="http://schema.org/ListItem"><a itemprop="item" href="https://www.minoryx.com/clinical-studies/clincal-study-calyx/"></a><span><a itemprop="item" href="/clinical-studies/clincal-study-calyx/"></a><span class="selected" title="CALYX" itemprop="name">CALYX</span></span><meta itemprop="position" content="2"/></span> </span> </div> </div> </div> </article> </section></li> </ul> <ul id="panel_pacientes33_1" class="panel_pacientes"> <li data-index="0" id="panel_pacientes_item31_1" class="item col-0 clearfix"><section class="mdl-pacientes"> <div class="m-articles"> <article class="active"> <div class="m-info1"> <div class="m-content"> <div> <div class="m-texto"> <div> <div class="m-title"><div>The CALYX Clinical Study in cALD</div></div> <div class="m-text"><p style="text-align: justify;">The CALYX trial is a phase 3, multicenter, randomized (1:1), double-blind, placebo-controlled, clinical study that has been designed to compare the efficacy and safety of leriglitazone with that of placebo in the treatment of cerebral adrenoleukodystrophy (cALD).</p></div> </div> </div> <div class="m-image deferbg" data-mobile="/content/imgsxml/panel_pacientes/caliyx-logo-color575.png" data-tablet="/content/imgsxml/panel_pacientes/caliyx-logo-color575.png" data-desktop="/content/imgsxml/panel_pacientes/caliyx-logo-color575.png"><img src="/content/thumbs/582_400-10/content/imgsxml/panel_pacientes/caliyx-logo-color575.png" class="deferimg" data-mobile="/content/imgsxml/panel_pacientes/caliyx-logo-color575.png" data-tablet="/content/imgsxml/panel_pacientes/caliyx-logo-color575.png" data-desktop="/content/imgsxml/panel_pacientes/caliyx-logo-color575.png" alt="" title="" ></div> </div> </div> </div> <div class="m-infoextra"> <div class="m-info2"> <div class="m-content"> <div class="m-text"><p style="text-align: justify;">CALYX will enroll 40 adult male X-ALD patients with progressive cALD defined by the presence of gadolinium-enhancing brain lesions, and where HSCT (haematopoietic stem cell transplantation) is not recommended or refused by the patient. Patients will be randomized either to leriglitazone or placebo with 1:1 randomization. The key exclusion criteria involve a Loes Score greater than 12, and patients that previously received HSCT or gene therapy. The trial has an adaptive duration with an initial efficacy read at 18 months and if needed subsequent efficacy assessments at 27 and 36 months respectively with the option to complete the study at any of the three time points once statistical significance is reached. After completing the randomized phase patients will continue into an open-label extension (OLE).</p> <p>The study was designed with input from FDA, as well as US clinical experts in X-ALD and patient advocacy groups.</p> <p>For further information visit:</p> <p><a href="https://beta.clinicaltrials.gov/study/NCT05819866">https://beta.clinicaltrials.gov/study/NCT05819866</a></p></div> </div> </div> <div class="m-info3"> <div class="m-content"> <div> <div class="m-head"><div class="m-title">Hospitals involved in CALYX Clinical Study</div> <div class="m-boton2 m-map sta-hoverOFF"><i></i><i></i><i></i><i></i>See map</div> </div> <div class="m-articles"> <article> <div class="m-country">Hospital Universitario Austral</div> <div class="m-titulo">Pilar, Buenos Aires</div> <div class="m-contacto">Argentina</div> <footer> </footer> </article> <article> <div class="m-country">Federal University of Sao Paulo (UNIFESP)</div> <div class="m-titulo">Vila Clementino, Sao Paulo</div> <div class="m-contacto">Brazil</div> <footer> </footer> </article> <article> <div class="m-country">Neuro Medicine Hospital / UF Health</div> <div class="m-titulo">Gainesville, Florida</div> <div class="m-contacto">United States</div> <footer> </footer> </article> <article> <div class="m-country">Masonic Cancer Center, University of Minnesota</div> <div class="m-titulo">Minneapolis, Minnesota</div> <div class="m-contacto">United States</div> <footer> </footer> </article> <article> <div class="m-country">Kennedy Krieger Institute</div> <div class="m-titulo">Baltimore, Maryland</div> <div class="m-contacto">United States</div> <footer> </footer> </article> <article> <div class="m-country">University of Utah</div> <div class="m-titulo">Salt Lake City, Utah</div> <div class="m-contacto">United States</div> <footer> </footer> </article> <article> <div class="m-country">Lucile Packard Children's Hospital</div> <div class="m-titulo">Stanford, California</div> <div class="m-contacto">United States</div> <footer> </footer> </article> <article> <div class="m-country">Massachusetts General Hospital</div> <div class="m-titulo">Boston, Massachusetts</div> <div class="m-contacto">United States</div> <footer> </footer> </article> </div> </div> </div> </div> <div class="m-info4"> <div class="m-content"> <div> <div class="m-head"><div class="m-title">Hospitals involved in CALYX Clinical Study</div> <div class="m-boton2 m-list sta-hoverOFF"><i></i><i></i><i></i><i></i>See list</div> </div> <div class="m-mapa"> <img src="/content/imgs/white.png" class="deferimg" data-desktop="/negocio/plantillas/panels/pacientes/mapa.jpg" data-tablet="/negocio/plantillas/panels/pacientes/mapa.jpg" data-mobile="/negocio/plantillas/panels/pacientes/mapa.jpg" alt="Map"> <div class="puntos"> <div class="punto" style="top:96.92898272552783%; left:39.32320252469814%"> <div class="dot" ></div> <div class="pointdata"> <div class="m-country">Hospital Universitario Austral</div> <div class="m-titulo">Pilar, Buenos Aires</div> <div class="m-contacto">Argentina</div> <footer> </footer> </div> </div> <div class="punto" style="top:91.6656669865643%; left:42.78437156970362%"> <div class="dot" ></div> <div class="pointdata"> <div class="m-country">Federal University of Sao Paulo (UNIFESP)</div> <div class="m-titulo">Vila Clementino, Sao Paulo</div> <div class="m-contacto">Brazil</div> <footer> </footer> </div> </div> <div class="punto" style="top:50.575500954198475%; left:25.695201744820068%"> <div class="dot" ></div> <div class="pointdata"> <div class="m-country">Neuro Medicine Hospital / UF Health</div> <div class="m-titulo">Gainesville, Florida</div> <div class="m-contacto">United States</div> <footer> </footer> </div> </div> <div class="punto" style="top:31.586058758314856%; left:23.780101394169836%"> <div class="dot" ></div> <div class="pointdata"> <div class="m-country">Masonic Cancer Center, University of Minnesota</div> <div class="m-titulo">Minneapolis, Minnesota</div> <div class="m-contacto">United States</div> <footer> </footer> </div> </div> <div class="punto" style="top:39.52592023714321%; left:28.4706626864646%"> <div class="dot" ></div> <div class="pointdata"> <div class="m-country">Kennedy Krieger Institute</div> <div class="m-titulo">Baltimore, Maryland</div> <div class="m-contacto">United States</div> <footer> </footer> </div> </div> <div class="punto" style="top:34.91200110864745%; left:15.541825095057035%"> <div class="dot" ></div> <div class="pointdata"> <div class="m-country">University of Utah</div> <div class="m-titulo">Salt Lake City, Utah</div> <div class="m-contacto">United States</div> <footer> </footer> </div> </div> <div class="punto" style="top:38.681402439024396%; left:8.697718631178706%"> <div class="dot" ></div> <div class="pointdata"> <div class="m-country">Lucile Packard Children's Hospital</div> <div class="m-titulo">Stanford, California</div> <div class="m-contacto">United States</div> <footer> </footer> </div> </div> <div class="punto" style="top:31.40256025659756%; left:34.76937280284415%"> <div class="dot" ></div> <div class="pointdata"> <div class="m-country">Massachusetts General Hospital</div> <div class="m-titulo">Boston, Massachusetts</div> <div class="m-contacto">United States</div> <footer> </footer> </div> </div> </div> </div> </div> </div> </div> </div> </article> </div> </section></li> </ul> <ul id="panel_textofoto33_3" class="panel_textofoto"> <li data-index="0" id="panel_textofoto_item12_3" class="item col-0 clearfix"><section class="mdl-textofoto"> <div class="m-articles"> <article> <div class="m-info1"> <div class="m-content"> <div> <div class="m-texto"> <div> <div class="m-title"><div>Contact</div></div> <div class="m-text"><p>Feel free to contact us in case you are interested in any of these clinical studies</p></div> </div> <div> <div class="m-email"> <a href="mailto:info@minoryx.com" title="info@minoryx.com">info@minoryx.com</a> </div> <div class="m-phone"> <a href="tel:+34 93 544 14 66" title="+34 93 544 14 66">+34 93 544 14 66</a> </div> </div> </div> <div class="m-image deferbg" data-mobile="/content/imgsxml/panel_textofoto/contacto523.jpg" data-tablet="/content/imgsxml/panel_textofoto/contacto523.jpg" data-desktop="/content/imgsxml/panel_textofoto/contacto523.jpg"> <img src="/content/imgs/white.png" class="deferimg" data-mobile="/content/imgsxml/panel_textofoto/contacto523.jpg" data-tablet="/content/imgsxml/panel_textofoto/contacto523.jpg" data-desktop="/content/imgsxml/panel_textofoto/contacto523.jpg" alt="" title="" > </div> </div> </div> </div> </article> </div> </section> <script type="text/javascript"> var ruta = "/"; 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