New Albany, New York
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INCB 18424-303: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 (TRuE-AD1)
NCT03745638 For more information, please contact Incyte Corporation at 1.855.463.3463
Phase
3Span
Sponsor
NEW ALBANY, Indiana
Recruiting
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria
Phase
2Span
97 weeksSponsor
Escient Pharmaceuticals, IncNew Albany, Indiana
Recruiting
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC. The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI > 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no). This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.
Phase
3Span
283 weeksSponsor
AstraZenecaNew Albany, Indiana
Recruiting
Efficacy/Safety of ALTB-268 in Subjects w/Moderately to Severely Active UC Refractory to Biologics
ALTB-268-201 is a Phase 2a, multicenter, single arm, multiple-dose, open-label study evaluating the efficacy and safety of ALTB-268 in subjects with moderately to severely active UC. The study consists of a Screening Phase, an Induction Phase, and a Maintenance Phase. Upon successful completion of the Screening Phase, subjects will return to the clinic for their first visit, which must occur within 28 days of SV1. Eligible subjects will be enrolled to receive a SC loading dose of ALTB-268. followed by a weekly maintenance dose of ALTB-268 in the 12 week Induction Study Phase. During the Induction Phase, study participants will be evaluated weekly at V0 (Day 1), V1 (Week 1), V2 (Week 2), V3 (Week 3), V4 (Week 4), V5 (Week 5), V6 (Week 6), V7 (Week 7), V8(Week 8), V9 (Week 9), V10 (Week 10), and V11 (Week 11) and V12 (Week 12; End of Induction Phase). Participants entering the maintenance study phase will continue to receive the SC dose of ALTB-268 every two weeks, up to week 52. Upon completion of the maintenance study phase, study participants will be asked to return for an end of study visit in approximately 4 weeks, for end of study visit.
Phase
2Span
122 weeksSponsor
AltruBio Inc.New Albany, Indiana
Recruiting
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants with Compensated Cirrhosis Due to MASH
Phase
3Span
380 weeksSponsor
89bio, Inc.New Albany, Indiana
Recruiting
A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
Phase
2Span
161 weeksSponsor
PfizerNew Albany, Indiana
Recruiting
A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared with Placebo in Adult Participants with Moderate to Severe Hidradenitis Suppurativa
Phase
3Span
109 weeksSponsor
MoonLake Immunotherapeutics AGNew Albany, Indiana
Recruiting
Pembrolizumab vs. Observation in People With Triple-negative Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Pembrolizumab
PRIMARY OBJECTIVES: I. To evaluate whether observation results in a non-inferior recurrence-free survival (RFS) compared to adjuvant pembrolizumab in early-stage triple-negative breast cancer (TNBC) patients who achieve a pathologic complete response (pCR) after neoadjuvant chemotherapy with pembrolizumab. II. To compare quality of life (QOL) at approximately 27 weeks as assessed by the Functional Assessment of Cancer Therapy-Breast (FACT-B) Trial Outcome Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To assess the social value of de-escalation of adjuvant breast cancer immunotherapy at approximately 27 weeks and, by modeling, over a lifetime. (Value of Care) SECONDARY OBJECTIVES: I. To evaluate whether observation compared to adjuvant pembrolizumab impacts the following: Ia. RFS by stage at presentation and by receipt of prior anthracycline therapy; Ib. Adverse event rate: difference in Grade 3 or higher adverse event rates overall and Grade 3 or higher immune-related adverse events (irAEs) rates; Ic. Overall Survival (OS); Id. Locoregional recurrence (LRR both isolated LRR as first events and LRR events simultaneous with DM); Ie. RFS, LRR, OS, adverse events, and QOL by age (=< 45, 46-65, and > 65), race, and ethnicity; If. Adverse events related to receipt of radiotherapy. II. To assess the value of de-escalation of breast cancer immunotherapy from the payer perspective at approximately 27 weeks and, by modelling, over a lifetime. (Value of Care) III. To compare patient out-of-pocket costs at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) IV. To compare financial toxicity at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To compare work/productivity impairment at approximately 27 weeks between patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) EXPLORATORY OBJECTIVES: I. To describe trajectories of QOL over time among patients randomized to adjuvant pembrolizumab versus (vs.) observation. (Quality of Life) II. To compare various QOL domains after approximately 27 weeks as assessed by the 5 subscales of the FACT-B Index between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) III. To compare self-reported symptomatic adverse events at approximately 27 weeks assessed by the patient reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) between patients randomized to adjuvant pembrolizumab versus observation. (Quality of Life) IV. To describe trajectories of financial toxicity and work/productivity impairment over time from baseline to approximately 27 weeks among patients randomized to adjuvant pembrolizumab versus observation. (Value of Care) V. To develop and assess a measure of value from the patient perspective at approximately 27 weeks. (Value of Care) OUTLINE: Patients are randomized to 1 of 2 arms after completing neoadjuvant chemotherapy in combination with pembrolizumab, followed by definitive breast surgery. ARM I (PEMBROLIZUMAB): Patients receive pembrolizumab intravenously (IV) on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up. ARM II (OBSERVATION): Patients undergo observation on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.
Phase
3Span
520 weeksSponsor
Alliance for Clinical Trials in OncologyNew Albany, Indiana
Recruiting
Evaluate REC-4881 in Patients With FAP
This is a Phase 1b/2, trial to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of REC-4881 in participants with Familial Adenomatous Polyposis (FAP). This two-part study will treat participants with phenotypic classical FAP with disease involvement of the duodenum or the residual colon/rectum/pouch as the primary disease site. Part 1 of the study enrolled seven participants with FAP who are post-colectomy/proctocolectomy. Participants were randomized to Placebo or REC-4881. Part 2 of the study will treat participants with escalating dose levels of REC-4881 during the Dose Finding. Participates in Cohort Expansion will be treated with a dose(s) to determine the RP2D.
Phase
1/2Span
160 weeksSponsor
Recursion Pharmaceuticals Inc.New Albany, Indiana
Recruiting
Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)
A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)
Phase
3Span
307 weeksSponsor
Novartis PharmaceuticalsNew Albany, Indiana
Recruiting