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NCT ID: NCT04705051 Terminated - Clinical trials for Congenital Cystic Kidney Disease

Long-term Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) With Venglustat

STAGED-PKD-EXT
Start date: February 9, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD). Secondary Objective: - To determine the effect of early versus delayed treatment with venglustat on the renal function (estimated glomerular filtration rate [eGFR] [Chronic Kidney Disease Epidemiology Collaboration {CKD-EPI} equation]). - To characterize the safety profile of venglustat. - To evaluate the effect of venglustat on the lens by ophthalmological examination. - To evaluate the effect of venglustat on mood using Beck Depression Inventory-II (BDI-II).

NCT ID: NCT04689594 Terminated - Clinical trials for Superficial Esophageal Cancer

A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the Steroid Administration Risk Group

Start date: February 4, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal wound site after extensive ESD for superficial esophageal cancer in the steroid administration risk group.

NCT ID: NCT04680637 Terminated - Clinical trials for Active Systemic Lupus Erythematosus

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

NCT ID: NCT04677179 Terminated - Colitis, Ulcerative Clinical Trials

A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)

INSTRUCT-UC
Start date: March 22, 2021
Phase: Phase 2
Study type: Interventional

The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks.

NCT ID: NCT04674748 Terminated - Solid Tumors Clinical Trials

To Assess the Safety, Tolerability and Pharmacokinetics of INCB086550

Start date: February 3, 2021
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability, and PK of INCB086550 and determine the Maximum Tolerated Dose (MTD) and/or recommended Phase 2 Dose(RP2D) of INCB086550, whichever is lower, in Japanese participants with advanced solid tumors.

NCT ID: NCT04638153 Terminated - Achondroplasia Clinical Trials

A Study Of Safety, Tolerability And Effectiveness Of Recifercept In Children With Achondroplasia

Start date: December 2, 2020
Phase: Phase 2
Study type: Interventional

Approximately 63 participants will be randomized to one of three doses to receive Recifercept either - Low Dose - Medium Dose - High Dose Participants will will attend the clinic at baseline and at Day 1, 4, 8, 15, 29 & then Month 2, 3 6, 9 & 12. Assessments include safety, blood sampling, physical examination, vital signs, anthropometric body measurements & patient/caregiver quality of life questionnaires Participants will received treatment with Recifercept for 12 months. All participants who complete the study and in the opinion of the investigator, continue to have a positive risk:benefit profile, will be offered to enroll into an open-label extension (OLE) study. A PK cohort will include 12 participants who will randomly receive a single dose of 3 mg/kg of Phase 2 study (process 1c) formulation and a single dose of 3 mg/kg of the proposed Phase 3 (process 2) study formulation in a cross over study. Dose of the cohort could be changed due to emerging safety and efficacy data in the study.

NCT ID: NCT04614246 Terminated - Endometriosis Clinical Trials

Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the Womb

SCHUMANN
Start date: January 29, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: - Study duration: 155 up to 285 days - Treatment duration: 84 days - Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo

NCT ID: NCT04612790 Terminated - Bullous Pemphigoid Clinical Trials

A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.

FJORD
Start date: March 31, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the use of benralizumab is effective in the treatment of patients symptomatic Bullous Pemphigoid (BP).

NCT ID: NCT04612725 Terminated - Clinical trials for Chronic Spontaneous Urticaria

A Study to Investigate the Use of Benralizumab in Patients With Chronic Spontaneous Urticaria Who Are Symptomatic Despite the Use of Antihistamines (ARROYO)

ARROYO
Start date: October 27, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the use of benralizumab is effective in the treatment of chronic spontaneous urticaria (CSU) who are symptomatic despite the use of antihistamines.

NCT ID: NCT04598477 Terminated - Pemphigus Vulgaris Clinical Trials

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

ADDRESS+
Start date: July 15, 2021
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open label extension (OLE) trial on the efficacy, safety, patient outcome measures, tolerability, immunogenicity, PK and PD of efgartigimod PH20 SC in adult PV or PF participants, who participated in antecedent trial ARGX-113-1904. This trial provides extension of efgartigimod PH20 SC treatment and retreatment options for participants who have been randomized to efgartigimod PH20 SC treatment arm in the trial ARGX-113-1904, and the first treatment of efgartigimod PH20 SC and retreatment options for participants who had been randomized to placebo arm in trial ARGX-113-1904. Trial ARGX-113-1905 evaluates ability to (further) taper prednisone therapy and achieve Clinical Remission (CR) off therapy (CRoff), the ability to achieve CR and CR on minimal therapy (CRmin) for participants who had not yet achieved CRmin, and the ability to treat flare; and assess patient outcome measures and the safety, PD, PK and immunogenicity of efgartigimod PH20 SC over the duration of trial. Study duration: Up to 60 weeks for participants who receive IMP administration up to 52 weeks and with a follow-up period of 8 weeks after the last IMP administration