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190 Clinical Trials near Great Neck, NY
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerThis trial studies a chemotherapy treatment that adjusts based on how well patients respond initially. It targets younger patients with Down syndrome who have certain types of blood cancer. The treatment aims to effectively kill cancer cells while reducing side effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:91 - 3
Key Eligibility Criteria
Disqualifiers:Promyelocytic Leukemia, Prior Therapy, Others
280 Participants Needed
Combination Therapy for Langerhans Cell Histiocytosis
New Hyde Park, New York
This trial uses a combination of two drugs, vinblastine and prednisone, to treat children with Langerhans Cell Histiocytosis. The treatment works by stopping abnormal cell growth and reducing inflammation. Vinblastine and prednisone have been used in various combinations to treat Langerhans Cell Histiocytosis (LCH) with some success in managing symptoms and achieving remission.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:< 18
Key Eligibility Criteria
Disqualifiers:Pregnancy, Prior Systemic Therapy, Others
1400 Participants Needed
Crizotinib for Non-Small Cell Lung Cancer
East Hills, New York
This randomized phase III trial studies how well crizotinib works in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Pregnancy, Cardiac Arrhythmia, Interstitial Lung Disease, Others
Must Not Be Taking:CYP3A4 Inhibitors, CYP3A4 Inducers
168 Participants Needed
Radiation vs. Radiation + Lymph Node Dissection for Breast Cancer
Flushing, New York
This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Inflammatory Breast Cancer, Other Malignancy, Pregnancy, Others
Must Be Taking:Anti-HER2 Therapy
2012 Participants Needed
Chemotherapy + Radiation Therapy for Head and Neck Cancer
Mineola, New York
This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Prior Invasive Malignancy, Severe Cardiac Disease, Severe Infections, Autoimmune Disease, Others
Must Not Be Taking:Immunosuppressants, Anti-PD-1 Agents
613 Participants Needed
ProstAtak® Immunotherapy + Radiation for Prostate Cancer
North Hills, New York
This trial is testing ProstAtak® immunotherapy with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak® kills cancer cells and helps the immune system learn to attack any remaining cancer cells, potentially improving treatment outcomes.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Not Listed
711 Participants Needed
Pumitamig + Chemotherapy for Colorectal Cancer
Mineola, New York
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiovascular Disease, Others
Must Not Be Taking:Checkpoint Inhibitors
990 Participants Needed
Pumitamig + Chemotherapy vs Nivolumab + Chemotherapy for Stomach Cancer
Lake Success, New York
The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiovascular Disease, Coagulation Disorders, Others
690 Participants Needed
ARD-101 for Prader-Willi Syndrome
Mineola, New York
The goal of this clinical trial is to learn if ARD-101 works to treat hyperphagia-related behavior in patients with Prader-Willi syndrome (PWS) when used in a long term setting. It will also teach us about the safety of ARD-101.
The main questions it aims to answer are:
What medical problems do participants have when taking ARD-101 in a long term setting
Does ARD-101 improve the total score of the HQCT-9 (hyperphagia questionnaire for clinical trials, 9 questions)?
Eligible participants will:
Have completed treatment on the AVK-101-301 study through Week 12/End of Treatment
Take ARD-101 every day for up to 12 months.
Visit the clinic at Months 1, 3, 6 and 12 during dosing and then have tele-visits at Week 2, Months 3 and 9, then 4 weeks after stopping the ARD-101.
Patients/Caregivers will keep a daily diary.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:13+
Key Eligibility Criteria
Disqualifiers:Complications, Others
90 Participants Needed
Nucresiran for Amyloidosis
Manhasset, New York
The purpose of this study is to:
* Evaluate the efficacy of nucresiran compared to placebo on reducing all-cause mortality and cardiovascular (CV) events
* Evaluate the efficacy of nucresiran compared to placebo on additional assessments of CV events and/or death
* Evaluate the efficacy of nucresiran compared to placebo on patient-reported health status and health-related quality of life
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:NYHA Class IV, PND Score IIIa, Others
Must Not Be Taking:TTR-lowering Therapy
1250 Participants Needed
KarXT + KarX-EC for Alzheimer's Disease
Lake Success, New York
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:60 - 85
Key Eligibility Criteria
Disqualifiers:Hepatic Impairment, Major Depression, Schizophrenia, Others
Must Be Taking:Acetyl Choline Esterase Inhibitors, Memantine
586 Participants Needed
Sacituzumab Tirumotecan + Pembrolizumab for Endometrial Cancer
Mineola, New York
Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.
* EC is a type of cancer that starts in the tissues inside the uterus (womb)
* pMMR indicates that certain normal proteins are present in the cancer cells
* Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery
* Recurrent means the cancer came back after surgery
Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.
The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Female
Key Eligibility Criteria
Disqualifiers:Sarcomas, DMMR, Cardiovascular, Others
Must Not Be Taking:Immunosuppressants, T-cell Inhibitors
1123 Participants Needed
Sacituzumab Tirumotecan + Pembrolizumab for Breast Cancer
Mineola, New York
Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Cardiovascular Disease, Others
Must Not Be Taking:Immunosuppressants, Steroids
1000 Participants Needed
Itepekimab for Sinusitis
Great Neck, New York
EFC18418 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 study with 3 treatment groups. The purpose of the study is to evaluate the efficacy, safety and tolerability of 2 dosing regimens of itepekimab compared to placebo as add-on therapy to intranasal corticosteroids (INCS) in male and female participants with chronic rhinosinusitis with nasal polyps (CRSwNP) aged 18 years of age and older.
Study details include:
* The study duration per participant (4-week screening, 52-week treatment, 20-week safety follow-up) will be up to 76 weeks. For participants transitioning to the LTS18420 study, the study duration will be 56 weeks.
* The treatment duration will be up to 52 weeks.
* The number of visits will be 9 site visits and 20 phone/home visits.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Smoking, Severe Asthma, Lung Disease, Others
Must Be Taking:Intranasal Corticosteroids
210 Participants Needed
RO7790121 for Crohn's Disease
Fresh Meadows, New York
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Short Bowel, Others
Must Not Be Taking:Anti-TL1A Therapy
425 Participants Needed
RO7790121 for Crohn's Disease
Queens Village, New York
This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Ulcerative Colitis, Short Bowel, Pregnancy, Infections, Others
Must Not Be Taking:Anti-TL1A Therapy
600 Participants Needed
Neladalkib for Non-Small Cell Lung Cancer
New Hyde Park, New York
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Oncogenic Drivers, Cardiovascular Disease, Others
Must Not Be Taking:ALK Inhibitors
450 Participants Needed
BMS-986365 for Prostate Cancer
Mineola, New York
The purpose of this study is to compare the efficacy and safety of BMS-986365 versus the investigator's choice of therapy in participants with Metastatic Castration-resistant Prostate Cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Sex:Male
Key Eligibility Criteria
Disqualifiers:Cardiac Disease, Brain Metastasis, Liver Metastasis, Others
Must Be Taking:Androgen Receptor Inhibitors
960 Participants Needed
Benralizumab for Asthma
New Hyde Park, New York
This study evaluates the efficacy and safety of benralizumab as an add-on therapy in uncontrolled eosinophilic asthma participants treated with medium-dose ICS-LABA compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 75
Key Eligibility Criteria
Disqualifiers:Pulmonary Disease, Chronic Infections, Smoking, Others
Must Be Taking:ICS-LABA
400 Participants Needed
Amivantamab + FOLFIRI for Colorectal Cancer
Mineola, New York
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) and and the length of time until a participant dies (overall survival), when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus either cetuximab or bevacizumab and FOLFIRI given to participants with Kirsten rat sarcoma viral oncogene/ neuroblastoma RAS viral oncogene homolog (KRAS/ NRAS) and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type recurrent, unresectable or metastatic colorectal cancer who have previously received chemotherapy.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:ILD, Second Malignancy, HER2-positive, Others
Must Not Be Taking:Irinotecan, EGFR Agents, MET Agents
700 Participants Needed
Why Other Patients Applied
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."
AG
Paralysis PatientAge: 50
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
Omecamtiv Mecarbil for Heart Failure
Manhasset, New York
The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Acute Coronary Syndrome, Dialysis, Others
Must Be Taking:Loop Diuretics
1800 Participants Needed
Low Dose Tamoxifen for Breast Cancer
Lake Success, New York
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Premenopausal, Endometrial Pathology, Others
Must Be Taking:Endocrine Therapy
1156 Participants Needed
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:ILD, Pneumonitis, Pulmonary Fibrosis, Others
Must Not Be Taking:EGFR Inhibitors, MET Inhibitors
1000 Participants Needed
Surgery + Chemotherapy for Pleuropulmonary Blastoma
New Hyde Park, New York
This phase III trial tests how well surgery plus chemotherapy compared to surgery alone works in treating patients with type I pleuropulmonary blastoma (PPB), and tests how well surgery plus standard chemotherapy with the addition of topotecan works compared to surgery plus standard chemotherapy alone in treating patients with type II and III PPB.
Historically, most children with type I PPB had surgery and approximately 40% of children with type I PPB received chemotherapy following their surgery, usually for 22-42 weeks. There has not been a consistent standard for which children with type I PPB receive chemotherapy after surgery. For patients whose tumor has been removed completely with surgery, observation without chemotherapy may work as well as giving chemotherapy after surgery in preventing a return of the PPB tumor.
The standard chemotherapy for patients with types II or III PPB in the United States is four cycles of IVADo (ifosfamide, vincristine, dactinomycin, and doxorubicin) followed by 8 cycles of IVA (ifosfamide, vincristine and dactinomycin). Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Dactinomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Topotecan is in a class of medications called topoisomerase I inhibitors. It works by interfering with tumor cell DNA which kills them. Giving topotecan in addition to standard IVADo and IVA chemotherapy regimens may shrink the cancer as well as or better than the standard therapy or could decrease the chance the tumor spreads while causing fewer side effects.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:< 21
Key Eligibility Criteria
Disqualifiers:Prior Chemotherapy, Charcot-Marie-Tooth, Pregnancy, Others
Must Not Be Taking:Antiretrovirals
110 Participants Needed
NTLA-2002 for Hereditary Angioedema
Mineola, New York
This Phase 3 study aims to evaluate the efficacy and safety of NTLA-2002 compared to placebo in participants with HAE.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:16+
Key Eligibility Criteria
Disqualifiers:Other Angioedema, LNP Hypersensitivity, Others
60 Participants Needed
Islatravir/Lenacapavir for HIV
Manhasset, New York
The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on a stable standard of care regimen for ≥ 6 months prior to screening. The standard of care includes 2 or 3 medicines, antiretroviral agents (ARVs).
The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Hepatitis B, Hepatitis C, Tuberculosis, Others
Must Be Taking:Antiretrovirals
600 Participants Needed
Islatravir + Lenacapavir for HIV
Flushing, New York
The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening.
The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Virologic Failure, Active Infections, Hepatitis B, Others
Must Be Taking:B/F/TAF
609 Participants Needed
Spesolimab for Pyoderma Gangrenosum
Lake Success, New York
The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\^2 to 80 cm\^2 in size.
This study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth.
In Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab.
In both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks.
Participants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Non-PG Lesions, Active Infections, HIV, Others
Must Be Taking:Corticosteroids
90 Participants Needed
Dapirolizumab Pegol for Lupus
Manhasset, New York
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16+
Key Eligibility Criteria
Disqualifiers:HIV, Malignancy, Heart Disease, Others
Must Be Taking:Antimalarials, Corticosteroids, Immunosuppressants
450 Participants Needed
RO7790121 for Ulcerative Colitis
Great Neck, New York
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:16 - 80
Key Eligibility Criteria
Disqualifiers:Crohn's Disease, Pregnancy, Cancer, Others
Must Not Be Taking:Anti-TL1A Therapy
400 Participants Needed
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