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Immunosuppressant

Personalized Medication for Severe Ulcerative Colitis

Phase 4

Recruiting

Led By Jeffrey Berinstein, MD, MSc

Research Sponsored by Berinstein, Jeffrey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 100 days (intervention plus 90 days of follow-up)

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to develop personalized treatments for people admitted to hospital with ASUC to help them avoid colectomy & ensure their safety. #ASUC #colectomy

Who is the study for?

This trial is for hospitalized patients with acute severe ulcerative colitis, who've had at least one dose of certain biologic treatments. They must be able to take oral meds, follow the study plan including daily symptom tracking, and women must use effective contraception during the study.

What is being tested?

The trial aims to personalize treatment for ulcerative colitis using Upadacitinib tablets or Cyclosporine orally/injection along with standard steroids. It's testing if these strategies can prevent colectomy (surgical removal of the colon) safely before a larger trial.

What are the potential side effects?

Possible side effects include increased infection risk due to immune system suppression, liver issues from Upadacitinib, kidney problems from Cyclosporine, and typical steroid-related effects like mood swings, blood sugar changes, and bone weakening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 100 days (intervention plus 90 days of follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 100 days (intervention plus 90 days of follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 100 days (intervention plus 90 days of follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of inpatient physicians reporting trial design acceptable

Proportion of patients reporting trial design acceptable

Proportion of patients who complete the trial who successfully underwent the second randomization (non-responders) or continued current therapy (responders) of all enrolled patients.

+4 more

Secondary study objectives

Incidence and severity of adverse events

Proportion of patients in initial clinical response (C-reactive protein and number of bowel movements) without non-trial rescue therapy or colectomy at 120 hours (5 days) after initiating first stage therapy per to treatment and ATS.

Proportion of patients in steroid-free remission at 90 days

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Oral Upadacitinib then Methylprednisolone plus cyclosporine infusionExperimental Treatment3 Interventions

Upadacitinib 30 mg BID for stage 1. If a patient is a non-responder to Upadacitinib 30 mg, then the study team will stop Upadacitinib and initiate Methylprednisolone IV 30mg twice a day plus Cyclosporine (2 milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) for stage 2.

Group II: Oral Upadacitinib then MethylprednisoloneExperimental Treatment3 Interventions

Oral Upadacitinib 30mg BID for stage 1 then for patients that are non-responders, add rescue Methylprednisolone IV 30mg twice a day in addition to continuing Upadacitinib for stage 2.

Group III: Oral UpadacitinibExperimental Treatment1 Intervention

Upadacitinib 30 mg BID

Group IV: Methylprednisolone then UpadacitinibExperimental Treatment2 Interventions

Methylprednisolone IV 30mg twice a day Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2

Group V: Methylprednisolone then CyclosporineExperimental Treatment3 Interventions

Methylprednisolone IV 30 mg BID Stage 1 and if determined to be a non-responder to Methylprednisolone, patient will receive rescue Cyclosporine (2milligram/kilogram (mg/kg) per day aiming for levels 200-400 nanograms per milliliter (ng/mL)) in addition to continuing Methylprednisolone for stage 2.

Group VI: Methylprednisolone plus Upadacitinib then increased UpadacitinibExperimental Treatment3 Interventions

Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and if determined to be a non-responder to Methylprednisolone and 45 mg Oral Upadacitinib, patient will receive rescue Upadacitinib 30mg BID in addition to continuing Methylprednisolone for stage 2.

Group VII: Methylprednisolone plus Upadacitinib then cyclosporineExperimental Treatment3 Interventions

Methylprednisolone IV 30mg BID and Oral Upadacitinib 45mg everyday stage 1 and then Cyclosporine 2 mg/kg per day aiming for levels 200-400ng/mL for stage 2.

Group VIII: Methylprednisolone plus UpadacitinibExperimental Treatment2 Interventions

Methylprednisolone IV 30mg BID plus Upadacitinib 45mg every day.

Group IX: MethylprednisoloneExperimental Treatment2 Interventions

Methylprednisolone Intravenous (IV) 30 milligram (mg) twice a day (BID)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intravenous Methylprednisolone

2011

N/A

~40