Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
Recruiting
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC). Participants will be randomized to receive 1 of 3 efavaleukin alfa doses or placebo during a 12-week induction period. Participants who complete the 12-week induction period will have the option to enter an exploratory long-term treatment period for up to 40 weeks (total of up to 52 weeks of treatment) if, in... Read More
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
11/22/2023
Locations: Harvard Medical School - Brigham and Womens Hospital, Boston, Massachusetts +1 locations
Conditions: Ulcerative Colitis
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
Recruiting
This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib... Read More
Gender:
All
Ages:
Between 2 years and 17 years
Trial Updated:
11/21/2023
Locations: Boston Children's Hospital, Boston, Massachusetts
Conditions: Ulcerative Colitis
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
Recruiting
This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Gender:
All
Ages:
18 years and above
Trial Updated:
10/25/2023
Locations: Massachusetts General Hospital Cancer Center, Boston, Massachusetts +1 locations
Conditions: Autoimmune Disease, Crohn Disease, Dermatomyositis, Inflammatory Bowel Disease, Multiple Sclerosis, Rheumatoid Arthritis, Sjogren Syndrome, Systemic Lupus Erythematosus, Systemic Scleroderma, Ulcerative Colitis, Hematopoietic and Lymphoid Cell Neoplasm, Psoriasis, Psoriatic Arthritis, Malignant Solid Neoplasm
High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Recruiting
The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.
Gender:
All
Ages:
Between 5 years and 25 years
Trial Updated:
10/09/2023
Locations: Boston Children's Hospital, Boston, Massachusetts
Conditions: Inflammatory Bowel Disease, Crohn Disease, Ulcerative Colitis, Vitamin D Deficiency
A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis
Recruiting
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in adolescents (≥ 12 years up to < 18 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment), or until marketing authorization is obtained in the participant's country, whiche... Read More
Gender:
All
Ages:
Between 12 years and 17 years
Trial Updated:
10/05/2023
Locations: Boston Children's Hospital, Boston, Massachusetts
Conditions: Ulcerative Colitis
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
Recruiting
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins,... Read More
Gender:
All
Ages:
16 years and above
Trial Updated:
08/30/2023
Locations: Boston Medical Center, Boston, Massachusetts +1 locations
Conditions: Ulcerative Colitis
ABTECT - Maintenance
Recruiting
This is a multicenter, randomized study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins,... Read More
Gender:
All
Ages:
16 years and above
Trial Updated:
06/28/2023
Locations: Boston Medical Center, Boston, Massachusetts +2 locations
Conditions: Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
Recruiting
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins,... Read More
Gender:
All
Ages:
16 years and above
Trial Updated:
06/27/2023
Locations: NECCR Primacare Research, LLC, Fall River, Massachusetts
Conditions: Ulcerative Colitis
A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and preventative methods for specific and complex conditions.
Gender:
All
Ages:
Between 18 years and 85 years
Trial Updated:
11/22/2022
Locations: Sanguine Biosciences, Waltham, Massachusetts
Conditions: Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome, Alzheimer Disease, Amyloidosis, Ankylosing Spondylitis, Arthritis, Alopecia Areata, Asthma, Atopic Dermatitis, Autism, Autoimmune Hepatitis, Behcet's Disease, Beta-Thalassemia, Cancer, Celiac Disease, Kidney Diseases, COPD, Crohn Disease, Cystic Fibrosis, Diabetes, Dravet Syndrome, DMD, Fibromyalgia, Graves Disease, Thyroid Diseases, Hepatitis, Hidradenitis Suppurativa, ITP, Leukemia, ALS, Lupus or SLE, Lymphoma, Multiple Sclerosis, Myasthenia Gravis, Heart Diseases, Parkinson Disease, Pemphigus Vulgaris, Cirrhosis, Psoriasis, Schizophrenia, Scleroderma, Sickle Cell Disease, Stroke, Ulcerative Colitis, Vasculitis, Vitiligo
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
Recruiting
Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations with. In this study, the investigators hope to find out if dietary therapy by either the Specific Carbohydrate Diet (SCD) or the Mediterranean diet will help improve ulcerative colitis symptoms for patients with mild to moderately active disease. In addition, the investigators will compare disease acti... Read More
Gender:
All
Ages:
Between 18 years and 75 years
Trial Updated:
05/27/2022
Locations: Massachusetts General Hospital, Boston, Massachusetts
Conditions: Ulcerative Colitis