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NCT ID: NCT05735483 Recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess the Long-Term Safety and Efficacy of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

ADorable-2
Start date: March 9, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to <18 years of age with moderate-to-severe atopic dermatitis

NCT ID: NCT05735080 Recruiting - Breast Cancer Clinical Trials

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

INX-315-01
Start date: March 28, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. This study will evaluate approximately 6 dose levels of daily INX-315 in Part A, at least two dose levels will be evaluated in Part B to identify the Recommended Phase 2 Dose (RP2D) in patients with ovarian cancer, and Part C will evaluate combination treatment of INX-315 plus a CDK4/6i and selective estrogen receptor degrader (SERD) in HR+/HER2- breast cancer patients who have progressed on prior CDK4/6i regimen.

NCT ID: NCT05734105 Recruiting - GIST Clinical Trials

A Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib

INSIGHT
Start date: December 13, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib.

NCT ID: NCT05734040 Completed - Influenza Clinical Trials

Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects.

Start date: May 10, 2023
Phase: Phase 2
Study type: Interventional

The present study OVX836-006 aims principally to: - Confirm feasibility of the concomitant administration of the vaccines under normal clinical conditions, i.e. as two separate concomitant injections into opposite arms; - Introduce an additional representative brand of Quadrivalent Inactivated Influenza Vaccines ; - Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the Hemagglutinin response; - Demonstrate the absence of interaction between OVX836 and Quadrivalent Inactivated Influenza Vaccines on the nucleoprotein response; - Evaluate the absolute vaccine efficacy of OVX836 compared to placebo in order to corroborate the efficacy signals previously detected in the OVX836 previous studies; - Evaluate the combined vaccine efficacy of OVX836 + Quadrivalent Inactivated Influenza Vaccines versus OVX836 + placebo, and versus double placebo.

NCT ID: NCT05732402 Recruiting - Lupus Nephritis Clinical Trials

An Open-label Study of Povetacicept (ALPN-303) in Autoimmune Kidney Diseases

RUBY-3
Start date: March 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to evaluate multiple dose levels of povetacicept (ALPN-303) in adults with immunoglobulin A (IgA) nephropathy, membranous nephropathy, lupus-related kidney disease (lupus nephritis). or anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period, participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month treatment extension period and an optional 52 week treatment extension period.

NCT ID: NCT05730725 Active, not recruiting - Psoriasis Clinical Trials

A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

Start date: April 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.

NCT ID: NCT05730036 Recruiting - Clinical trials for Relapsed Refractory Multiple Myeloma (RRMM)

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

LINKER-MM3
Start date: September 18, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: - How long participants benefit from receiving linvoseltamab compared with EPd - How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much - What side effects happen from taking linvoseltamab compared to EPd - How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd - If there is any improvement in pain after treatment with linvoseltamab compared to EPd

NCT ID: NCT05729568 Active, not recruiting - HIV Infections Clinical Trials

A Study of GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Start date: May 15, 2023
Phase: Phase 2
Study type: Interventional

The goal of this study is to test the effectiveness, safety, and tolerability of the combination of broadly neutralizing antibodies (bNAbs) (teropavimab (formerly GS-5423) and zinlirvimab (formerly GS-2872)) with lenacapavir (LEN) in virologically suppressed adults with HIV-1 infection. The purpose of this study is to evaluate the efficacy of switching to a regimen of LEN, teropavimab, and zinlirvimab, versus continuing on baseline oral antiretroviral therapy (ART) as determined by the proportion of participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) ≥ 50 copies/mL at Week 26.

NCT ID: NCT05727904 Recruiting - Melanoma Clinical Trials

Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.

Start date: March 30, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanoma. Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.

NCT ID: NCT05727189 Recruiting - Healthy Clinical Trials

A Study of Idazoxan in Healthy Participants

Start date: February 14, 2023
Phase: Phase 1
Study type: Interventional

Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1 form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults.