A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis
- Conditions
- moderate to severe ulcerative colitisMedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2019-003999-39-NO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 202
Age and Sex:
1. Male or female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 75 years, inclusive, at Visit 1 (Screen 1).
Type of Participant and Disease Characteristics:
2. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
3. Diagnosis (endoscopic and histological) of UC for =3 months prior to entry into the study. A report supporting disease duration and extent (eg, proctosigmoiditis, left sided colitis, or pancolitis) based upon prior endoscopy including a biopsy report must be available in the source documentation.
4. Participants with moderate to severe UC as defined by a total Mayo score (tMS) of =6, with a rectal bleeding subscore of =1 and an endoscopic subscore of =2 (any friability = 2).
5. Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
6. Participants must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC:
• Oral, intravascular, or intramuscular corticosteroids;
• Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]);
• Anti tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab, or golimumab);
• Anti integrin inhibitors (eg, vedolizumab);
• JAK inhibitor (eg, tofacitinib);
• Anti-IL-12/IL-23 inhibitors (eg, ustekinumab).
Local standards of care, as well as investigator assessment should be considered in any assessment.
7. Participants currently receiving permissible treatment for UC are eligible providing they have been on stable doses.
8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Weight:
9. Body weight must be >40 kg.
Informed Consent:
10. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 182
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, or clinical findings suggestive of Crohn’s disease.
2. Participants with known colonic stricture and participants with history of colonic or small bowel obstruction, resection, or stoma.
3. Participants with significant trauma or major surgery within 4 weeks of screening or planned a surgery during the study.
4. Participants with a history of bowel surgery within 6 months prior to baseline.
5. Participants displaying clinical signs of fulminant colitis or toxic megacolon.
6. Participants with primary sclerosing cholangitis.
7. Participants with evidence of colonic dysplasia, adenomas or neoplasia. However, participants with adenomatous polyps identified on screening endoscopy will be eligible if the polyps have been completely removed and pathologic report is negative.
8. Participants with any condition possibly affecting oral drug absorption (eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass). Procedures such as gastric banding that simply divide the stomach into separate chambers are NOT exclusionary.
9. Have current or recent (within the past year) history of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, immunologic (eg, Felty’s syndrome) or neurologic disease, including but not limited to the following:
• History of acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) or any history of cerebrovascular disease within 24 weeks before screening;
• Chronic heart failure New York Heart Association Grade IV;
• History of liver cirrhosis;
• History of recurrent (=2) venous thrombosis or any arterial thromboembolism or known blood clotting disorders.
10. Cancer or history of cancer or history of any lymphoproliferative disorder (such as Epstein-Barr virus [EBV]-related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease), except for participants with adequately treated or excised non-metastatic basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ.
11. Infected with Mycobacterium tuberculosis (TB): History of multidrug resistant TB infection, any evidence of untreated, inadequately treated latent or active TB infection.
• A participant who is currently being treated for active TB infection is to be excluded.
• A participant who is currently being treated for latent TB infection with an adequate TB treatment regimen in the locale (in the opinion of the appropriately qualified personnel- which may include a pulmonary or infection disease specialist, or locally acceptable expert as defined by local guidelines) for at least 1 month can only be enrolled with documentation of treatment regimen, commitment of continuing treatment during the study and with prior approval by the sponsor.
12. History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
13. Clinically significant infections within 3 months of baseline (eg, those requiring hospitalization or parenteral antimicrobial therapy, or opportunistic infections), or a history of any infection otherwise judged by the inves
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method