CLINICAL TRIAL

MK-6194 for Ulcer

Locally Advanced
Recruiting · 18+ · All Sexes · Raleigh, NC

This study is evaluating whether a drug called MK-6194 is safe and well tolerated in people with ulcerative colitis.

See full description

About the trial for Ulcer

Eligible Conditions
Colitis · Colitis, Ulcerative · Ulcer · Ulcerative Colitis

Treatment Groups

This trial involves 2 different treatments. MK-6194 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
MK-6194
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
MK-6194-matching placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have been diagnosed with ulcerative colitis at least 3 months prior to screening. show original
Mildly to severely active UC.
You have had at least 1 prior conventional therapy and no more than 2 prior advanced therapies. show original
Participants > 50 years of age must have documentation of a colonoscopy within 3 years of the screening visit to exclude adenomatous polyps. Participants whose adenomas have been completely excised at screening are eligible.
Participants with extensive colitis for ≥ 8 years, or disease limited to the left side of the colon for ≥ 10 years, must either have had a full colonoscopy to assess for the presence of dysplasia within 1 year before first administration of study drug or a full colonoscopy to assess for the presence of malignancy at the screening visit.
You have no evidence of active TB, latent TB, or inadequately treated TB. show original
Body mass index (BMI) 18 to 35 kg/m^2 inclusive and weight ≥ 50 kg.
You are of childbearing potential and you or your partner are of childbearing potential show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Days 1, 29, 57, and 85
Screening: ~3 weeks
Treatment: Varies
Reporting: Days 1, 29, 57, and 85
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Days 1, 29, 57, and 85.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether MK-6194 will improve 2 primary outcomes and 13 secondary outcomes in patients with Ulcer. Measurement will happen over the course of Up to approximately 71 days.

Percentage of Participants Discontinuing Study Treatment Due to an AE
UP TO APPROXIMATELY 71 DAYS
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
UP TO APPROXIMATELY 71 DAYS
Change in Number of Natural Killer (NK) Cells in Whole Blood
BASELINE AND UP TO 85 DAYS (LAST STUDY VISIT)
The change in the number of NK cells in whole blood will be assessed.
BASELINE AND UP TO 85 DAYS (LAST STUDY VISIT)
Change in Number of Conventional T Cells (Tcons) in Whole Blood
BASELINE AND UP TO 85 DAYS (LAST STUDY VISIT)
The change in the number of Tcons in whole blood will be assessed.
BASELINE AND UP TO 85 DAYS (LAST STUDY VISIT)
Change in Number of Peripheral Regulatory T-cells (Tregs) in Whole Blood
BASELINE AND UP TO 85 DAYS (LAST STUDY VISIT)
The change in the number of peripheral Tregs in whole blood will be assessed.
BASELINE AND UP TO 85 DAYS (LAST STUDY VISIT)
Apparent Clearance (CL/F) of MK-6194
AT DESIGNATED TIME POINTS (UP TO 85 DAYS)
CL/F is defined as the apparent clearance of MK-6194 observed in plasma.
AT DESIGNATED TIME POINTS (UP TO 85 DAYS)
Apparent Half-life (t1/2) of MK-6194
AT DESIGNATED TIME POINTS (UP TO 85 DAYS)
t1/2 is defined as the time required for the plasma concentration of MK-6194 to decrease by 50%.
AT DESIGNATED TIME POINTS (UP TO 85 DAYS)
See More

Patient Q & A Section

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

What causes ulcer?

Stress, which may have been caused by the stressful life of a person during childhood, is considered a significant cause of the ulcers, especially when they are gastric ulcers. Gastritis, due to Helicobacter pylori, may also contribute to gastro-oesophageal ulcer if it remains untreated. Ulcers from NSAIDs can affect up to 50% of people with rheumatoid arthritis during the first 6 months, but the majority resolve spontaneously.

Anonymous Patient Answer

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

At about one hundred thousand per year, ulcer is the second most common chronic gastrointestinal condition in the United States. Data from a recent study indicate the need for more effective medical and public health programs to understand better how to prevent ulcer, and to optimize management of ulcer.

Anonymous Patient Answer

What are the signs of ulcer?

Diagnostic modalities include endoscopy, X-rays, and biopsy. Endoscopy is a major method used at the present time. It is useful in the determination of the extent of the disease and for treatment, e.g., surgery. It has not revealed any evidence that the treatment of ulcer with NSAIDs would be more effective or faster than placebo.

Anonymous Patient Answer

What is ulcer?

Ulcer is a wound-like inflammation and breakdown of tissues inside the body. In people with a gastric ulcer, there may be an inability to produce sufficient gastric acid in response to food that cannot be digested. Symptoms, which may include pain, may include a feeling of fullness. The size of the ulcer may be inversely related to hunger.\n

Anonymous Patient Answer

What are common treatments for ulcer?

We have little evidence regarding effectiveness of the treatments used for gastric ulcer in general. There is no clear consensus, however, on effective treatments. There are [no reliable clinical data about the treatments used for GI hemorrhage from any cause. Many treatments are [not used] because of lack of evidence, but some therapies used in acute and chronic peptic ulcer can be [used] for chronic bleeding as well. There are many [novel treatments being] tested for peptic ulcer that are [not yet available] for clinical use. A summary of treatments from multiple sources (including [the Mayo Clinic] and [the SCLC Center] [http://sccirc.cancer.harvard.

Anonymous Patient Answer

Can ulcer be cured?

Ulcer is a disease associated with many clinical symptoms that can vary widely with patient, situation, and observer. Most of these symptoms can be treated to some degree using drugs, non-drug measures, and/or surgery. However, many cases will remain unaltered or improved, even without current medical intervention. The cure of ulcer does not lie in altering these symptoms, but in treating the underlying causes of ulcer.

Anonymous Patient Answer

What is mk-6194?

A recent development, mk-6194 has shown safety in Phase 2 clinical trials. Mk-6194 was found to be efficacious in phase 2 studies in two distinct indications, H. pylori-specific gastritis and peptic ulcer disease. The drug's efficacy and safety profile suggest its potential for use as a novel therapy for the treatment of H. pylori infection associated gastritis and peptic ulcer disease.

Anonymous Patient Answer

What are the latest developments in mk-6194 for therapeutic use?

There is a lack of the preclinical data required by regulatory authorities for the use of mk-6194 in the clinic. Clinical trials are continuing with respect to its use in multiple myeloma and gastrointestinal cancer.

Anonymous Patient Answer

What is the average age someone gets ulcer?

The data suggests that an ulcer occurs between age 40 and 50. People that are in the later years of life are at a higher risk for presenting with an ulcer and are more likely to get the ulcer recurrent. In contrast to the average age of presentation, the average time to the recurrence of an ulcer is around 7.25 years. It therefore suggests that ulcer patients should be screened every seven to nine months at least up until age 65. There is also a higher prevalence rate for the presence of co-morbid medical conditions like hypertension, diabetes, obesity, and sleep apnea. There is also a need to establish early symptoms for future diagnosis.

Anonymous Patient Answer

How does mk-6194 work?

MK-6194 appears to be non-toxic, even when administered at high doses, and inhibits proliferation of colonocytes. Hence we conclude that the colonopathy seen in our animal model of MK-6194 treatment will be a consequence of MK-6194's activity, not a cause of it.

Anonymous Patient Answer

How serious can ulcer be?

Ulcerated lesions are the second most common indication for urgent referral to a SSCU. Although rare, they may cause substantial morbidity or, more rarely, death.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Ulcer by sharing your contact details with the study coordinator.