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NCT ID: NCT03656718 Active, not recruiting - Neoplasms by Site Clinical Trials

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Start date: October 31, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: - non-small cell lung cancer (NSCLC) - renal cell carcinoma (RCC) - unresectable or metastatic melanoma - hepatocellular carcinoma (HCC) - microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC) - in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician - In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

NCT ID: NCT03656562 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus (SLE)

Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients

Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 (ianalumab) or CFZ533 (iscalimab) in patients with systemic lupus erythematosus (SLE) to enable further development of these compounds as treatment in this disease population

NCT ID: NCT03656510 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection

Start date: November 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).

NCT ID: NCT03654274 Completed - Endometriosis Clinical Trials

SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

Start date: May 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).

NCT ID: NCT03653507 Active, not recruiting - Clinical trials for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

GLOW
Start date: November 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.

NCT ID: NCT03653026 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

U-Accomplish
Start date: December 6, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03651505 Active, not recruiting - Clinical trials for X-linked Hypophosphatemia

X-linked Hypophosphatemia Disease Monitoring Program

Start date: July 16, 2018
Phase:
Study type: Observational

The objectives of this observational study are to characterize XLH disease presentation and progression and to assess long-term effectiveness and safety of burosumab.

NCT ID: NCT03650114 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

ALITHIOS
Start date: December 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

NCT ID: NCT03643965 Completed - Clinical trials for Primary IgA Nephropathy

Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy

Nefigard
Start date: September 5, 2018
Phase: Phase 3
Study type: Interventional

The overall aim of the study is to evaluate the efficacy, safety, and tolerability of Nefecon 16 mg per day in the treatment of patients with primary IgAN (Immunoglobulin A nephropathy) at risk of progressing to end-stage renal disease (ESRD), despite maximum tolerated treatment with renin-angiotensin system (RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

NCT ID: NCT03635983 Completed - Melanoma Clinical Trials

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Start date: September 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread