Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Evaluation of Upadacitinib Re‑induction in Patients with Ulcerative Colitis Who Have Lost Response to a 30 mg Maintenance Dose

Verified siteInvestigationalNo placebo
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease? Our clinical trial advisor will do it for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults with Ulcerative Colitis, a long‑lasting condition that causes inflammation and ulcers in the lining of the colon, leading to symptoms such as frequent diarrhea, abdominal pain, and blood in the stool. Participants must have previously taken the oral medication Upadacitinib at a dose of 30 mg each day but then stopped responding well to it. In the trial, these individuals will receive a short course of the same medication, either as a modified‑release tablet (30 mg) or a prolonged‑release tablet (45 mg), to try to restore the benefit that was lost.

The sole aim of the research is to determine how often patients regain a clinical response, meaning a noticeable improvement in their symptoms, and to see how many achieve clinical remission, which is the absence of disease activity. After an initial screening visit, participants will start the re‑induction therapy and will be followed for several weeks with regular check‑ins to record symptom changes and any side effects. No additional procedures beyond routine visits are required, and the study does not involve a comparison with an inactive treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Assessment

    After you join the study, you will have a baseline visit. During this visit the study team will confirm that you have ulcerative colitis and that you previously used a 30 mg maintenance dose of upadacitinib. They will also record your medical history, perform a physical exam, and obtain laboratory tests to establish your starting condition.

  2. Step 2

    Start of Upadacitinib Re‑induction Therapy

    You will begin taking the study medication, upadacitinib, as a re‑induction therapy. The tablet you receive will be either a 30 mg modified‑release tablet or a 45 mg prolonged‑release tablet, depending on the study assignment. The tablet is taken by mouth once each day.

  3. Step 3

    Daily Medication Use

    You will continue to take the assigned upadacitinib tablet every day. The medication is intended to be taken at the same time each day, with or without food, as directed by the study protocol.

  4. Step 4

    Scheduled Study Visits and Assessments

    Throughout the trial you will attend scheduled study visits on predefined weeks. At each visit the study team will evaluate whether you have achieved a clinical response or a clinical remission of your ulcerative colitis. They will also repeat safety assessments, such as lab tests and symptom questionnaires.

  5. Step 5

    End of Treatment and Final Evaluation

    At the end of the treatment period you will have a final study visit. During this visit the overall effectiveness of the re‑induction therapy will be assessed, including the proportion of participants who achieved a clinical response and those who achieved clinical remission.

Who can join the trial?

8 criteria

  • Sign an informed consent form (a written agreement that shows you understand the study and agree to take part) before any screening procedures begin.
  • Be at least 18 years old and younger than 65 years.
  • Have blood and kidney test results within the required ranges: liver enzymes called ALT (alanine transaminase) and AST (aspartate aminotransferase) must be less than twice the normal upper limit (ULN); kidney function measured by GFR (estimated glomerular filtration rate) must be above 0 mL/min/1.73 m²; white blood cell count must be higher than 2,500 per microliter; absolute neutrophil count (a type of white blood cell) must be higher than 1,500 per microliter; platelet count must be higher than 100,000 per microliter; absolute lymphocyte count must be higher than 850 per microliter; and hemoglobin (the protein that carries oxygen in your blood) must be higher than 10 g/dL.
  • Be willing and able to follow all study visits and required procedures.
  • Not be incarcerated and be able to give free consent without legal guardianship or other restrictions.
  • Have a confirmed diagnosis of moderate to severe ulcerative colitis (a type of inflammatory bowel disease) that previously responded to the medication upadacitinib but has lost that response within the last 8 weeks. At the screening visit, your disease activity must score 5‑9 on the modified Mayo score (a scale doctors use to measure ulcerative colitis severity) and 2‑3 on the endoscopic sub‑score (a rating based on a visual exam of the colon).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the screening visit.
  • Women who could become pregnant must use at least one reliable method of birth control from the first day of the study until at least 30 days after the last dose of the study drug.

Who cannot join the trial?

27 criteria

  • You have a current diagnosis of Crohn’s disease or a condition called indeterminate colitis.
  • A test during screening shows a positive result for C. difficile toxin in your stool (a type of bacterial infection).
  • You have had an infection that needed treatment with IV (through a vein) antibiotics in the past 30 days, or oral/intramuscular antibiotics in the past 14 days.
  • You have a current or past history of recurrent or widespread shingles (herpes zoster), even if it happened only once.
  • You have a current or past history of widespread herpes simplex infection, even if it happened only once.
  • You have had gastrointestinal (GI) dysplasia (abnormal cells) that has not been completely removed.
  • You have a history of any cancer, except a successfully treated non‑melanoma skin cancer or a localized pre‑cancer of the cervix (carcinoma in situ).
  • You have a history of a GI perforation (a hole in the intestine) that was not caused by appendix removal or an injury, or you have diverticulitis or a high risk of perforation according to your doctor.
  • You are allergic or have a strong sensitivity to upadacitinib or any of its ingredients.
  • You have previously received a stem cell transplant.
  • You have a current diagnosis of severe (fulminant) colitis or a condition called toxic megacolon (a dangerous swelling of the colon).
  • You have had an organ transplant that requires you to stay on medicines that suppress your immune system.
  • You have had a stroke, heart attack, coronary stent, heart bypass surgery, or a blockage of a retinal vein, unless it happened more than 6 months ago and your doctor decides the benefits outweigh the risks.
  • You experienced a serious adverse event (a serious side effect) that was judged to be caused by upadacitinib in the past.
  • You have taken any experimental (investigational) drug within the last 30 days or five drug half‑lives (whichever is longer), or you are currently enrolled in another clinical study.
  • You used rectal aminosalicylates or corticosteroids, enemas, or suppositories (except those needed for the screening endoscopy) within 7 days before the screening endoscopy and during the screening period.
  • You took cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days before the baseline visit.
  • You took azathioprine or 6‑mercaptopurine within 10 days of the baseline visit.
  • You received intravenous (IV) corticosteroids within 14 days before screening or during the screening period.
  • You need corticosteroids to stay in the study.
  • You used non‑steroidal anti‑inflammatory drugs (NSAIDs) within 7 days before baseline, except for topical (skin) NSAIDs or low‑dose aspirin taken for heart protection.
  • You have a clinically significant history of drug or alcohol abuse within the last 6 months.
  • You have conditions that could affect how the study drug is absorbed, such as short bowel syndrome (very short intestine).
  • You have had a total or partial removal of the colon (colectomy), an ileoanal pouch, a Kock pouch, or an ileostomy, or you are planning bowel surgery.
  • You have active tuberculosis (TB) or a latent (inactive) TB infection.
  • You received a fecal microbial transplantation (a stool‑based therapy) within 30 days before baseline.
  • You are currently receiving total parenteral nutrition (TPN) (nutrition given through a vein) or plan to receive it at any time during the study.
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease? Our clinical trial advisor will do it for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Upadacitinib is an oral medication taken as a tablet that works by targeting specific pathways in the immune system to reduce inflammation. In this study, patients with ulcerative colitis who stopped responding to their regular 30 mg maintenance dose are given Upadacitinib again to see if it can regain control of their symptoms. The drug is provided in tablet forms that release the medicine gradually, helping maintain steady levels in the body during the re‑induction period.

What is already known about the treatment

Upadacitinib - Upadacitinib is taken by mouth as a tablet, available in a 30 mg modified‑release form and a 45 mg prolonged‑release form; patients swallow the tablet with water. It is an approved medicine that is widely studied and used for inflammatory conditions such as ulcerative colitis and rheumatoid arthritis. The drug works by blocking Janus kinase (JAK) enzymes, which stops certain signals that cause inflammation in the body. It belongs to the pharmacological class of JAK inhibitors.

Investigated diseases

Ulcerative colitis - a chronic inflammatory disease that affects the lining of the colon, beginning in the rectum and often spreading upward. It causes ulceration and inflammation that lead to frequent loose stools, abdominal pain, and blood in the stool. The condition typically follows a pattern of flare‑ups, when symptoms worsen, and periods of relative calm. Over time the inflamed area can extend to involve larger portions of the colon. The ongoing inflammation may result in changes to the colon wall, such as thickening or scarring.
Trial detailsLast updated 8 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526174-16-00Protocol codeReCOUPEstimated enrolment100 patientsSponsori-GETAID

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease? Our clinical trial advisor will do it for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.