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NCT ID: NCT05245578 Completed - Healthy Volunteer Clinical Trials

Safety Evaluation of KX01 Ointment 1% in Japanese Healthy Male Subjects

Start date: November 16, 2021
Phase: Phase 1
Study type: Interventional

Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects

NCT ID: NCT05240612 Completed - Clinical trials for HTLV-1-Associated Myelopathy (HAM)

A Clinical Pharmacological Study of MT-3921 in Subjects With HTLV-1 Associated Myelopathy (HAM)

Start date: May 2, 2022
Phase: Phase 1
Study type: Interventional

The purposes of this study is to assess the safety, tolerability, and pharmacokinetics of MT-3921 in subjects with Human T-cell Leukemia Virus Type 1 (HTLV-1)-Associated Myelopathy(HAM). Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.

NCT ID: NCT05238675 Completed - Bronchiectasis Clinical Trials

A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis

Start date: March 21, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day. Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff. The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05231044 Completed - Actinic Keratosis Clinical Trials

A Multi-Center Study to Evaluate the Efficacy and Safety of KX01 Ointment 1% on Actinic Keratosis on Face or Scalp

Start date: December 21, 2021
Phase: Phase 3
Study type: Interventional

This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.

NCT ID: NCT05223868 Completed - Plaque Psoriasis Clinical Trials

A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis

FRONTIER 1
Start date: February 3, 2022
Phase: Phase 2
Study type: Interventional

Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis.

NCT ID: NCT05219630 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Change in Symptom and Quality of Life in COPD by Budesonide/Glycopyrronium/Formoterol Fumarate Pressurized Metered Dose Inhaler (BGF pMDI)

EBISU
Start date: May 16, 2022
Phase:
Study type: Observational

This study is primarily aimed to investigate whether PROs can be improved after the initiation of BGF pMDI in real world clinical settings. While the study is 12-weeks in duration, the initial 4-week period will be used to assess immediate onset of benefits while the full study length will serve to demonstrate durability in response. Study design: This is a 12-week, multi-center, prospective observational study in which a total number of 107 patients will be enrolled. Adult outpatients with COPD without asthma history and who initiate on BGF pMDI as decided by the physicians in their routine clinical care will be consecutively invited for this study. Investigators (physicians) make screening their patients prior to the study entry and make informed consent explanation at their usual visit timing to the all eligible patients. After fulfilling eligibility criteria at study entry, the patients are enrolled in the study and the investigators will follow up the patients as in routine clinical practice and collect the data at baseline, at week 4 and week 12. Data Source(s): The study sites will be selected where BGF pMDI is used as a treatment option for COPD patients. Investigators participating in the study evaluate lung function (i.e., spirometry) for COPD patients in a daily practice Statistical Analysis: All data including patient characteristics at baseline will be summarized using appropriate descriptive statistics. Where applicable, changes from baseline at each timepoint will also be summarized using descriptive statistics. A comprehensive statistical analysis plan (SAP) including more details will be prepared prior to the database lock.

NCT ID: NCT05200247 Completed - Clinical trials for Generalized Pustular Psoriasis

An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options

Start date: February 17, 2022
Phase: Phase 3
Study type: Interventional

This Expanded Access trial in Japan is open to people with a serious skin disease called Generalized Pustular Psoriasis (GPP). This program provides a medicine called spesolimab to people with a GPP flare-up who have no alternative treatment options. Participants get a single infusion of spesolimab into a vein. They can get another spesolimab infusion one week after the first infusion if the doctors think it is helpful. Participants are in the program for about 4 months and visit the study site about 5 to 6 times. The doctors regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05183347 Completed - Healthy Clinical Trials

A Study in Healthy Japanese Men to Test How Well Different Doses of BI 1291583 Are Tolerated

Start date: February 4, 2022
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.

NCT ID: NCT05182840 Completed - Clinical trials for Kidney Disease, Chronic

A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

Start date: January 11, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05180357 Completed - Nasal Polyps Clinical Trials

RANS. Study in Patients With Severe Eosinophilic Asthma and Nasal Polyps.

RANS
Start date: November 23, 2021
Phase:
Study type: Observational

The purpose of this observational study is to describe the population of patients with SEA + NP who have been prescribed FASENRA and assess available clinical outcomes for both NP and asthma.