Upadacitinib (ABT-494) for Ulcer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Gastro Data Wiesbaden /ID# 150404, Wiesbaden, Germany
Ulcer+3 More
Upadacitinib (ABT-494) - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug can help people with ulcerative colitis.

See full description

Eligible Conditions

  • Ulcer
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Ulcer

Study Objectives

This trial is evaluating whether Upadacitinib (ABT-494) will improve 1 primary outcome in patients with Ulcer. Measurement will happen over the course of Up to 288 Weeks.

Up to 288 Weeks
Assessing Treatment-Emergent Adverse Events

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Ulcer

Trial Design

5 Treatment Groups

Participants receiving Upadacitinib (ABT-494) Dose A or Dose B
1 of 5
Participants receiving Placebo
1 of 5
Participants receiving Upadacitinib (ABT-494) Dose C
1 of 5
Participants receiving Upadacitinib (ABT-494) Dose A
1 of 5
Participants receiving Upadacitinib (ABT-494) Dose B
1 of 5
Experimental Treatment

This trial requires 950 total participants across 5 different treatment groups

This trial involves 5 different treatments. Upadacitinib (ABT-494) is the primary treatment being studied. Participants will be divided into 5 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Participants receiving Upadacitinib (ABT-494) Dose A or Dose B
Drug
The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B.
Participants receiving Placebo
Drug
The participants in this arm will receive placebo until study is unblinded.
Participants receiving Upadacitinib (ABT-494) Dose C
Drug
The participants in this arm will receive Upadacitinib (ABT-494) dose C.
Participants receiving Upadacitinib (ABT-494) Dose A
Drug
The participants in this arm will receive Upadacitinib (ABT-494) dose A.
Participants receiving Upadacitinib (ABT-494) Dose B
Drug
The participants in this arm will receive Upadacitinib (ABT-494) dose B.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2810
Upadacitinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 288 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 288 weeks for reporting.

Closest Location

Minnesota Gastroenterology PA /ID# 151682 - Saint Paul, MN

Eligibility Criteria

This trial is for patients born any sex of any age. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met.
Note: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible
If female, participant must meet the criteria for Contraception Recommendations.
Women of childbearing potential must have a negative urine pregnancy test at Week 0 visit.
Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234).
Must be able and willing to give written informed consent and to comply with the requirements of this study protocol.

Patient Q&A Section

What are the signs of colitis?

"Most colitis-related symptoms are suggestive of the underlying condition, and only half of these signs may cause confusion with diarrhea. A stool test may be useful, but it may not accurately characterize inflammation and has poor specificity." - Anonymous Online Contributor

Unverified Answer

Can colitis be cured?

"Colitis may be cured with corticosteroids for short-term use, although relapse may be frequent. Better understanding of the pathophysiology of colitis and implementation of well-controlled, well-designed clinical trials with long follow-up are needed to help establish more definitive guidelines for treatment." - Anonymous Online Contributor

Unverified Answer

What are common treatments for colitis?

"Medications and alternative therapies are utilized by 1 out of 8 Americans with colitis.\n\n- American Cancer Society: Colorectal Cancer\n- Colorectal Cancer Prevention and Intervention Program website - Comprehensive and descriptive information regarding [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) pathology, medical management, and treatment options in the U.S."" - Anonymous Online Contributor

Unverified Answer

What is colitis?

"colitis can be considered as inflammation of the large and/or left-sided colon in patients with symptoms. The diagnosis should be suspected in the setting of abdominal complaints and be confirmed by endoscopic procedures such as colonoscopy. The severity of colitis can be classified in three different grades by clinical findings, histology and by imaging methods, namely computed tomography (CT) and magnetic resonance imaging (MRI) scans. The most appropriate treatment of this disorder depends on the degree of severity of inflammation. It should be tailored to the individual situation of the patient." - Anonymous Online Contributor

Unverified Answer

What causes colitis?

"There are several causes which may increase risk for colitis. These include genetic factors and environmental risk factors such as infectious pathogens. There is more than one trigger for colitis, and multiple causative factors may exist. The exact mechanism is different in different forms of colitis. It is a challenge to understand precisely what changes in gut cells can cause colitis, and to use that information to design new treatments." - Anonymous Online Contributor

Unverified Answer

How many people get colitis a year in the United States?

"From 1998 to 2002, there were 1,926 patients with [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) and 1,483 with Crohn's colitis in the VA Cooperative System. The rate for both is 0.36 per 100,000. The disease was diagnosed in an average of 2.4 years, with the interval of 9 months between symptom onset to symptom presentation and diagnosis on average. The average duration was 3.1 years for patients with ulcerative colitis and 4.7 years for those with Crohn's disease. The mean rate per year was 2.7 and 1.7 in patients with ulcerative colitis and Crohn's colitis, respectively." - Anonymous Online Contributor

Unverified Answer

Has upadacitinib (abt-494) proven to be more effective than a placebo?

"It was found that upadacitinib was more effective than a placebo in terms of remission, as well as maintaining remission and prolonging the duration of remission. The most common side effects were infections, hemorrhage and anemia. Data from a recent study was registered at the Japanese Clinical Trials Registry as JCR number J-11-0209." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of upadacitinib (abt-494)?

"This phase 2 study demonstrated that weekly-taken upadacitinib (abt-494) treatment is well-tolerated in patients with moderate-to-severe Crohn's disease. Common adverse events (AEs) occurred most frequently involving the gastrointestinal (GI) tract in all patients treated with upadacitinib, with fatigue and diarrhea being the most common, and most frequently in patients who received 25 mg twice-daily upadacitinib (abt-504 or ABT-0505)." - Anonymous Online Contributor

Unverified Answer

What is upadacitinib (abt-494)?

"UPDAs have a novel mechanism of action: they inhibit the action of certain members of the Src family of kinases. The inhibitors currently used to treat many cancers have been known and used for over 50 years. This is the first time an inhibitor of Src family members is being used to treat a serious disease in its devastating effects. With the Src family members being members of the receptor tyrosine kinase (RTKs) with an important role in cancer, drug development has focused on their development. However, the Src family of kinases are known to have other functions in the process of cell communication and motility." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets colitis?

"There is no evidence of overall improvement from age 20 to age 60 but improvements were found in age >60 years with better quality of life and more frequent surgeries. The findings suggest that patients with colitis become increasingly symptomatic when they reach a certain age." - Anonymous Online Contributor

Unverified Answer

What does upadacitinib (abt-494) usually treat?

"Upadacitinib (abt-494) is the first selective JAK2 inhibitor discovered. It is a novel anti-inflammatory JAK2 inhibitor. It shows promise in small Phase II clinical trials for treatment of ulcerative colitis. Upadacitinib (abt-494) is FDA approved treatment for polycythemia vera (PV) in May 2011 under IND. It also showed some promising activity in Phase III clinical trials for PV and chronic myelofibrosis (MF). Upadacitinib (abt-394) is currently undergoing extensive Phase II drug development." - Anonymous Online Contributor

Unverified Answer

How serious can colitis be?

"The severity of abdominal pain, fever and anorexia is suggestive of a serious complication of colitis viz., abdominal abscess or bowel rupture. Colonoscopy can be helpful in identifying the exact site of inflammation. Other indications of severe and potentially life-threatening cases of colitis include vomiting blood, hemoptysis and hematuria." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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