A OPEN-LABEL EXTENSION STUDY OF CP-690,550 AS MAINTENANCE THERAPY IN PATIENTS WITH CROHN*S DISEASE

Phase 2

Completed

• Conditions: Crohn's Disease; inflammatory bowel disease; 10017969

• Registration Number: NL-OMON43589
• Lead Sponsor: Pfizer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:;
1. Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure;
2. Women of childbearing potential must test negative for pregnancy prior to study enrolment.;
3. Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.;
4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.;
5. Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria

Subjects presenting with any of the following will be excluded from the study:;
1. Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.;
2. Subjects who were discontinued from the A3921084 study due to an adverse event that was not related to Crohn's disease.;
3. Evidence of active (draining) fistulae, intrabdominal or perineal collection or abscess at Baseline (MRI imaging is not required for entry to this study unless clinically indicated).;
4. Subjects with evidence of or suspected liver disease ie, liver injury due to methotrexate or primary sclerosing cholangitis.;
5. Subjects with evidence of blood dyscrasias at Baseline visit (as assessed by the laboratory results from Week 26 or early discontinuation visit from the A3921084 study):;
* Hemoglobin levels * 9.0 g/dL.;
* An absolute white blood cell (WBC) count of <3.0 x 10 to the power of 9/L (<3000/mm3) or absolute neutrophil count of <1.2 X 10 to the power of 9/L <1200/mm3) or absolute lymphocyte count of <0.5 x 109/L (<500/mm3).;
* Thrombocytopenia, as defined by a platelet count <100 x 10 to the power of 9/L (<100,000/mm3).;
6. Subjects who have been scheduled to receive any live or attenuated virus vaccination during study period and for 6 weeks after last dose of study drug.;
7. Women who are pregnant or breastfeeding, or planning pregnancy during the study period.;
8. Subjects with estimated GFR *40 mL/min based on Cockcroft-Gault calculation from Week 26 or early discontinuation visit from the A3921084 study.;
9. Subjects with total bilirubin, AST or ALT more than 1.5 times the upper limit of normal from Week 26 or early discontinuation visit from the A3921084 study.;
10. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including uncontrolled hypercholesterolemia), endocrine, pulmonary, cardiac, or neurological disease.;
11. Baseline 12-lead ECG (from Week 26 or early discontinuation visit from the A3921084 study) that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results (ie, baseline QTcF >450 ms, complete LBBB, acute or indeterminate age myocardial infarction, 2nd-3rd degree AV block, or serious bradyarrhythmias or tachyarrhythmias).;
12. Subjects who are expected to receive prohibited concomitant medications including medications that are either moderate to potent CYP3A4 inducers or inhibitors during the study period.;
13. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.;
14. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.;
15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
16. Subjects who are participating in or interested in participating in other investigational
studies during study A3921086.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety<br /><br>* Incidence and severity of adverse events, clinical laboratory abnormalities,<br /><br>and change from baseline in clinical laboratory values<br /><br><br /><br>Efficacy<br /><br>* As this is an open-label extension study, there will be no primary efficacy<br /><br>endpoint. All efficacy endpoints will be exploratory. Sustained clinical<br /><br>remission is defined as being in clinical remission at both Week 24 and Week 48<br /><br><br /><br>Health Outcome<br /><br>* Absolute scores and change from baseline in Inflammatory Bowel Disease<br /><br>Questionnaire (IBDQ) Total score and domain scores (Bowel Symptoms, Systemic<br /><br>Symptoms, Emotional Function and Social Function) over time</p><br>