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NCT ID: NCT06073119 Recruiting - Psoriasis Clinical Trials

A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis

SPECIFI-PSO
Start date: October 26, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It is designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Study details include a screening period (4 weeks and not less than 11 days before Day 1), a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of study visits will be 7.

NCT ID: NCT06073093 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

SPECIFI-RA
Start date: November 7, 2023
Phase: Phase 2
Study type: Interventional

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (6 weeks ± 3 days) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

NCT ID: NCT06057506 Recruiting - Clinical trials for Head Lice Infestation

Comparative Study for the Evaluation of Two Medical Devices on the Treatment of Head Lice Infestation

Start date: August 21, 2023
Phase: N/A
Study type: Interventional

Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation. The test items have been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimative convenience in use - making treatment of head lice infestation easy, and effective in few minutes. The main objective of this clinical study is to confirm the efficacy on head lice treatment of two Medical Devices, already in market.

NCT ID: NCT05904470 Recruiting - Hepatitis C Clinical Trials

A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.

NCT ID: NCT05893550 Recruiting - Behavior Problems Clinical Trials

Omega-3 Supplementation to Both Parent and Adolescent

Start date: March 5, 2018
Phase: Phase 3
Study type: Interventional

The overarching, long-term goals are to develop a non-invasive biological approach to prevention of youth aggression, and ultimately adult violence. The specific aims of this 2 x 2 randomized, double-blind, stratified, placebo-controlled trial of omega-3 supplementation to adolescents and caregivers are: (1) to investigate whether a nutritional intervention to adolescents and their parents can reduce externalizing behavior problems; (2) to examine the impact of a dual nutritional intervention to both parents and adolescents on adolescent externalizing behavior problems; (3) to identify mechanisms of action by which omega-3 supplementation impacts externalizing behavior in adolescents. It is expected that omega-3 supplementation will reduce adolescent behavior problems, and that dual supplementation to both the caregiver and adolescent will result in exponential improvements in adolescent behavior. A secondary prediction is that improvements in neurocognitive functioning will partially account for any behavioral improvements observed. Effects on scholastic ability are also explored.

NCT ID: NCT05540327 Recruiting - Clinical trials for Systemic Lupus Erythematosus

The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)

Start date: September 16, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the long term safety and efficacy of orally administered M5049 in participants with subacute cutaneous lupus erythematosus (SCLE), discoid lupus erythematosus (DLE) and/or systemic lupus erythematosus (SLE) who have completed the 24 week treatment period of Willow study (MS200569_0003 [NCT05162586]).

NCT ID: NCT05379114 Recruiting - Head Lice Clinical Trials

Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation

Start date: May 18, 2022
Phase: N/A
Study type: Interventional

Pediculosis capitis or head lice infestation is a human medical condition caused by the infestation of the hair by the parasitic insect Pediculus humanus capitis (human head lice). The most common symptom of infestation is pruritus (itching) on the head which normally intensifies 3 to 4 weeks after the initial infestation. The test item has been developed with the ambition to offer a complete head lice treatment, whilst also offering ultimate convenience in use - making treatment of head lice infestation easy, and effective in few minutes. The objectives of this clinical study are to assess the efficacy and the safety of a new Medical Device for lice infestation treatment compared to a comparator device, already in market.

NCT ID: NCT05273333 Recruiting - Clinical trials for Vulvovaginal Candidiasis, Genital

Effect of Ultra-gyn® on Vulvovaginal Candidiasis

Start date: February 23, 2022
Phase: N/A
Study type: Interventional

The aim of this post-market clinical follow up study is to confirm the performance and the safety of Ultra-gyn® (when used in accordance with its approved labelling)

NCT ID: NCT05039840 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus

APATURA
Start date: November 10, 2021
Phase: Phase 2
Study type: Interventional

This is a multinational, randomized, placebo-controlled, parallel treatment, Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18 to 70 years with active Systemic Lupus Erythematosus (SLE). Study details include: - Study duration: 36 weeks - Treatment duration: 24 weeks - Visit frequency: every 2 weeks

NCT ID: NCT04701983 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

AERIFY-1
Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD