Luetzen, Germany
- Featured
Study to evaluate HZN-825 in patients with Idiopathic Pulmonary Fibrosis (IPF)
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in subjects with IPF. Subjects will be screened within 8 weeks prior to the Baseline (Day 1) Visit. Approximately 360 subjects who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks using the following 2 stratification factors: Prior use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no; FVC % predicted at Baseline: ≥70% or <70%.
Phase
2Span
123 weeksSponsor
Horizon Therapeutics Ireland DACPhiladelphia, Pennsylvania
Recruiting
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A Double-blind Study to Evaluate the Safety of Glutamic Acid Decarboxylase Gene Transfer in Parkinson's Participants
The planned length of participation in the study for each participant will be approximately 7 months. This includes a screening period of up to 40 days, randomization and surgery, and a follow-up period of 26 weeks.
Phase
1/2Span
74 weeksSponsor
MeiraGTx, LLCPhiladelphia, Pennsylvania
Recruiting
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PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706
This study is designed to assess the ability of K0706 to slow the progression of PD. Preclinical animal model data have already demonstrated that K0706 has neuroprotective activity, but further development will require human clinical experience. This study will also allow determination of safety and tolerability of K0706 over many months in subjects with PD.
Phase
2Span
246 weeksSponsor
Sun Pharma Advanced Research Company LimitedPhiladelphia, Pennsylvania
Recruiting
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STEM-Parkinson's Disease
Up to 218 participants will enter the double-blinded, controlled, randomized clinical trial (RCT) and will self-administer treatments twice daily in the home setting over a period of 12 weeks following a 4 week baseline period. The RCT will have 6 study visits: 3 visits at the study center and 3 visits completed in the participant's home by video call.
Phase
N/ASpan
85 weeksSponsor
Scion NeuroStimPhiladelphia, Pennsylvania
Recruiting
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Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD
This is a 2-part (Part A [Genetic Screening] and Part B [Double-Blind Treatment]), Phase 2, multicenter, randomized, double-blind, placebo- controlled study evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of 2 fixed dose levels of BIA 28-6156 (10 and 60 mg/day) in approximately 237 subjects with genetically confirmed GBA-PD. Part A (Genetic Screening) is identifying individuals with a PD risk- associated variant in the GBA1 gene for potential enrolment into Part B (Double-Blind Treatment) of the study. Part B consists of a screening period to ensure that all protocol inclusion/exclusion criteria for Part B of the study are met (up to 5 weeks). After screening period, eligible subjects are randomized into 1 of 3 treatment arms (BIA 28-6156 10 mg/day, BIA 28-6156 60 mg/day, or placebo) in a 1:1:1 ratio, and enter a double-blind treatment period up to 78 weeks, followed by a 30-day (4 weeks) of safety follow-up period. Subjects must be receiving a stable dose of PD medication for at least 30 days before screening (for Part B [Double-Blind Treatment]) and continue to receive their usual PD medications throughout the study.
Phase
2Span
157 weeksSponsor
Bial R&D Investments, S.A.Philadelphia, Pennsylvania
Recruiting
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TemPo Studies
**All eligible study participants will receive at no cost:** • Study-related consultation and care • Study visits, tests, assessments, and procedures • Study drugs (investigational drug or placebo)
Phase
N/ASpan
212 weeksSponsor
Cerevel TherapeuticsPhiladelphia, Pennsylvania
Recruiting
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INCB 18424-304: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE-AD2) for 304
For more information, please contact Incyte Corporation at 1.855.463.3463
Phase
3Span
Sponsor
PHILADELPHIA, Pennsylvania
Recruiting
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Integument-PED study
The study drug consists of a cream of the medication or a placebo (same cream without the active drug) that will be applied once daily for 28 days. This treatment is experimental, and you (or your child) will have 1 in 2 chances to be part of the placebo part of the study. At the end of the study, participants may be eligible to participate in the open-labeled study, which would allow the participants to continue to receive the study treatment. More information will be made available to the participants should they be interested. Blood samples will be collected on screening, day 1 and week 4. If you consent to medical photography, it will be performed at day 1, week 1 and week 4. For more information and to register to the study, please visit the study page: http://eczema-study.com/
Phase
3Span
Sponsor
ArcutisPhiladelphia, Pennsylvania
Recruiting
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Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type
Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or **17-AVP-786-305.** Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks). Approximately 1200 participants will be enrolled at approximately 250 centers globally. All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.
Phase
3Span
500 weeksSponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.Philadelphia, Pennsylvania
Recruiting
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A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease
Phase
1Span
128 weeksSponsor
Hoffmann-La RochePhiladelphia, Pennsylvania
Recruiting