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NCT ID: NCT04781543 Recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

NCT ID: NCT04781205 Active, not recruiting - Clinical trials for Microbial Colonization

Genome Driven Primary Care Clinics - an RCT

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

A cluster randomized controlled study of 40 primary care clinics in Northern Israel (20 intervention clinics, 20 usual care clinics) to evaluate the value of introducing a precision medicine/genomic approach/paradigm on the clinical and economical outcomes of the clinics. Intervention includes 3 elements: 1. DNA extraction and evaluation (up to the level of WGS); 2. Feces sample for microbiome study, 3. Wearable devices for continuous monitoring of body functions. Expected number of participants is 100,000 in each arm. Results will be calculated for a clinic as a unit and not for individuals (each clinic to be compared to "twin" selected clinic).

NCT ID: NCT04780516 Completed - Psoriasis Clinical Trials

Study to Assess Change in Disease Symptoms in Adult Participants With Moderate to Severe Psoriasis Treated With Subcutaneous Risankizumab Injection According to Standard of Care

prIMMa
Start date: April 26, 2021
Phase:
Study type: Observational

Psoriasis is a chronic inflammatory skin condition that is characterized by symptoms such as pain, itching and discomfort. This can have severe impact on the quality of life including depression, embarrassment, and social isolation. The objective of this study is to evaluate how effective risankizumab is in changing the disease symptoms in adult participants with moderate to severe psoriasis. Risankizumab is an approved drug being developed for the treatment of psoriasis. Adult participants who are prescribed risankizumab treatment according to the local label will be enrolled in this study. Approximately 125 adult participants with moderate to severe psoriasis will be enrolled at multiple sites across Israel. Participants who are prescribed to receive subcutaneous risankizumab injection by their physician according to local label will be enrolled and will be followed for approximately 2 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, patient charts, questionnaires, and remote monitoring device (patch sensor).

NCT ID: NCT04779762 Not yet recruiting - Crohn Disease Clinical Trials

Stelara and Diet Trial for Crohn"s Disease

Start date: January 2022
Phase: N/A
Study type: Interventional

Dietary therapy involving the Crohn's disease exclusion diet (CDED) is an evolving strategy to target the microbiome and innate immunity in order to reduce inflammation and promote healing. The goal of the current pilot study is to evaluate the added benefit of treatment with Ustekinumab combined with CDED in anti TNF exposed patients compared to treatment with Ustekinumab alone in term of achieving remission.

NCT ID: NCT04779320 Recruiting - Clinical trials for Crohn's Disease (CD)

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Start date: April 30, 2022
Phase: Phase 3
Study type: Interventional

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.

NCT ID: NCT04779307 Recruiting - Colitis, Ulcerative Clinical Trials

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)

Start date: April 18, 2022
Phase: Phase 3
Study type: Interventional

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease. The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.

NCT ID: NCT04778033 Recruiting - Covid19 Clinical Trials

Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine

Start date: February 9, 2021
Phase:
Study type: Observational

In this study the investigators will explore the effect of the BNT162b2 COVID-19 Vaccine on semen analysis parameters among 75 fertile men. Fertile men will be regarded as such if they previously successfully impregnated their partners without the use of artificial reproductive technology, or men who previously had a normal sperm analysis exam by WHO criteria (2010). Those recruited will supply a single sperm sample 1-2 months following the second dose of the vaccination. In addition, the participants will fill a brief questionnaire with information regarding their medical and reproductive history. The investigators will examine the macroscopic and microscopic properties of the semen samples and compare them to the WHO semen analysis reference range in an attempt to ascertain whether the vaccine influences sperm parameters.

NCT ID: NCT04777994 Recruiting - Clinical trials for Advanced Solid Tumor Cancer

A Phase 1 Study With ABBV-CLS-484 in Subjects With Locally Advanced or Metastatic Tumors

Start date: March 9, 2021
Phase: Phase 1
Study type: Interventional

The study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy). Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.

NCT ID: NCT04777409 Active, not recruiting - Clinical trials for Early Alzheimer´s Disease

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)

Start date: May 18, 2021
Phase: Phase 3
Study type: Interventional

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

NCT ID: NCT04777396 Active, not recruiting - Clinical trials for Early Alzheimer's Disease

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)

Start date: May 18, 2021
Phase: Phase 3
Study type: Interventional

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.