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NCT ID: NCT06116916 Recruiting - Clinical trials for Diabetic Macular Edema (DME)

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema

Start date: January 9, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.

NCT ID: NCT06116890 Recruiting - Clinical trials for Neovascular Age-Related Macular Degeneration (nAMD)

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Neovascular Age-Related Macular Degeneration

Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with nAMD.

NCT ID: NCT06113445 Recruiting - Clinical trials for NonSegmental Vitiligo

A Study to Evaluate Efficacy and Safety of Povorcitinib in Participants With Nonsegmental Vitiligo (STOP-V1)

Start date: November 29, 2023
Phase: Phase 3
Study type: Interventional

This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.

NCT ID: NCT06113328 Recruiting - Clinical trials for Non-segmental Vitiligo

A Clinical Study of MK-6194 for the Treatment of Vitiligo (MK-6194-007)

Start date: November 27, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of MK-6194 in participants with non-segmental vitiligo. The primary hypothesis is that at least 1 MK-6194 dose is superior to placebo with regards to percent change from baseline in Facial Vitiligo Area Scoring Index (F-VASI) at Week 24.

NCT ID: NCT06112379 Recruiting - Breast Cancer Clinical Trials

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Start date: November 14, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

NCT ID: NCT06112301 Recruiting - Clinical trials for B-Cell Lymphoproliferative Disorder

Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay

Start date: January 2, 2024
Phase:
Study type: Observational

This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.

NCT ID: NCT06109935 Recruiting - Clinical trials for Growth Hormone Deficiency in Children

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

Start date: October 4, 2023
Phase:
Study type: Observational

The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in Japan. The study will last for about 1 year (at shortest) to 3 years (at longest) depending on when the participant takes part in the study. The participant will be asked to answer questionnaire(s) about how they feel about the growth hormone (GH) product treatment once during the study (at about 3 months after starting the Sogroya® treatment) and about 3 months after starting the Sogroya® treatment.

NCT ID: NCT06109779 Recruiting - Clinical trials for Biliary Tract Cancer

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Start date: December 4, 2023
Phase: Phase 3
Study type: Interventional

A global study to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in participants with BTC after surgical resection with curative intent.

NCT ID: NCT06109311 Recruiting - Type 2 Diabetes Clinical Trials

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

ACHIEVE-5
Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

NCT ID: NCT06107413 Recruiting - Clinical trials for Unresectable Metastatic Colorectal Cancer

Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

Start date: November 12, 2023
Phase: Phase 2
Study type: Interventional

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer. ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab is an drug approved for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab (FFB) in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care [SOC]) [dose optimization] on its own. Approximately 206 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide. In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with FFB at low or high doses determined in the safety lead in on two different dosing schedules. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. The study will run for a duration of approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.