Search Results Within Category "Infectious Diseases & Immune System"
2results
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
clinicaltrials@northshore.org
ALL
18 years to 80 years old
PHASE3
NCT03519945
* Inclusion Criteria
* Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
* Female participants must agree to contraception requirements.
* Exclusion Criteria
* Participants must not have developed a new condition, including cancer in the originator study.
* Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
* Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
* Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
DRUG: Mirikizumab
Ulcerative Colitis
Inflammatory Bowel Disease
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE)
clinicaltrials@northshore.org
ALL
18 years to 63 years old
PHASE3
NCT05843643
Inclusion Criteria:
* Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE.
* At Screening, must have at least one of the following:
* antinuclear antibody (ANA) positive (titer \>= 1:80)
* anti-double stranded deoxyribonucleic acid (dsDNA) positive
* anti-Smith positive
* Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) \>= 6, of which \>= 4 points are clinical (not based on laboratory criteria), independently reviewed by the MCDR at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as \>= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present.
* Physician's Global Assessment (PhGA) \>= 1 during screening period.
* On stable background treatment for \>= 60 days prior to Baseline (with the exception of oral corticosteroid \[OCS\], which must be at a stable dose for \>=14 days prior to Baseline) with
* antimalarial(s) \[hydroxychloroquine \<= 400 mg daily, chloroquine \<= 500 mg daily, quinacrine \<= 100 mg daily\];
* and/or prednisone (or prednisone-equivalent) (\<= 20 mg daily);
* and/or no more than 1 of the following: azathioprine (\<= 150 mg daily), 6-mercaptopurine (\<= 150 mg daily), mycophenolate mofetil (\<= 2 g daily), mycophenolate sodium \<= 1,440 mg/day, leflunomide (\<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (\<= 23.7 mg twice daily), methotrexate (\<= 25 mg weekly), or mizoribine (\<= 150 mg daily).
Exclusion Criteria:
* Class III/IV lupus nephritis that was treated with induction therapy within the 6 months prior to Screening.
* Active neuropsychiatric SLE (excluding lupus headache) within the 6 months prior to Screening.
* SLE overlap syndromes including, but not limited to, rheumatoid arthritis, systemic sclerosis, polymyositis, dermatomyositis, or mixed connective tissue disease (Sjögren's syndrome is permitted).
* Antiphospholipid syndrome and prior unprovoked venous or arterial thrombosis who are not on stable and adequate anticoagulation.
* Two or more episodes of herpes zoster, or one or more episodes of disseminated herpes zoster or herpes zoster ophthalmicus.
* History of malignancy, except for successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix.
* Pregnancy, breastfeeding, or considering becoming pregnant during the study.
* Clinically relevant or significant ECG abnormalities at Screening.
* Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. DRUG: Upadacitinib, DRUG: Placebo
Systemic Lupus Erythematosus
Systemic Lupus Erythematosus, SLE, Upadacitinib, Lupus