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NCT ID: NCT03729362 Completed - Clinical trials for Pompe Disease (Late-onset)

A Study Comparing ATB200/AT2221 With Alglucosidase Alfa/Placebo in Adult Subjects With Late-onset Pompe Disease

PROPEL
Start date: December 4, 2018
Phase: Phase 3
Study type: Interventional

This is a phase 3 double-blind randomized study to study the efficacy and safety of intravenous ATB200 Co-administered with oral AT2221 in adult subjects with Late Onset Pompe Disease compared with Alglucosidase Alfa/placebo.

NCT ID: NCT03727750 Completed - Pharmacokinetics Clinical Trials

Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML

Start date: July 3, 2019
Phase: Phase 4
Study type: Interventional

This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory CD33-positive AML.

NCT ID: NCT03722550 Completed - Healthy Infants Clinical Trials

Second Generation Human Milk Oligosaccharides Blend Study

Start date: September 19, 2018
Phase: N/A
Study type: Interventional

The aim of this trial is to show that infants fed these new formulas, containing a blend of 5 Human Milk Oligosaccharides (HMOs), allow for growth in line with infants fed formulas without HMOs. There will be different groups in the trial: three formula-fed groups and a breastfed group.

NCT ID: NCT03720470 Completed - Dermatitis, Atopic Clinical Trials

Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy

JADE Compare
Start date: October 29, 2018
Phase: Phase 3
Study type: Interventional

B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.

NCT ID: NCT03717155 Completed - Clinical trials for Squamous Non-Small Cell Lung Cancer

Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC

Start date: October 30, 2018
Phase: Phase 2
Study type: Interventional

The main purpose of the study was to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with treatment-naïve advanced squamous non-small-cell lung cancer (NSCLC).

NCT ID: NCT03715998 Completed - Clinical trials for Myocardial Infarction

Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction

QUORUM
Start date: June 4, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind, active-controlled, dose-titrating phase 2 study to evaluate the safety and efficacy of firibastat administered orally BID (2 daily doses) versus ramipril administered orally BID over 12 weeks after acute anterior MI. Subjects will be followed for 12 weeks (over 4 study visits). A total of 294 male and female subjects with a diagnosis of first acute anterior MI will be randomized. The subjects will need to have a primary percutaneous coronary intervention (PCI) of the index MI related artery within 24 hours after MI.

NCT ID: NCT03713632 Completed - Clinical trials for Hidradenitis Suppurativa

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

SUNRISE
Start date: February 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study assessed the safety and tolerability of secukinumab.

NCT ID: NCT03713619 Completed - Clinical trials for Hidradenitis Suppurativa

This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

SUNSHINE
Start date: January 31, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

NCT ID: NCT03695185 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Start date: March 26, 2019
Phase: Phase 2
Study type: Interventional

Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.

NCT ID: NCT03694522 Completed - Gastric Cancer Clinical Trials

A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer

FIGHT
Start date: September 14, 2018
Phase: Phase 2
Study type: Interventional

The main objective of the Phase 2 part of the study is to evaluate the efficacy of bemarituzumab (FPA144), a targeted antibody, in combination with modified FOLFOX6 compared to placebo in combination with modified FOLFOX6 in participants with advanced gastrointestinal cancer.