A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

Phase 1

Conditions: lcerative colitis
MedDRA version: 17.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-004580-79-EE

Lead Sponsor: Pfizer Inc, 235 East 42nd Street, New York, New York 10017

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 654

Inclusion Criteria

1. Subjects who met study entry criteria and completed 9-week induction treatment from Study A3921094 or A3921095.
2. Subjects who achieved clinical response in Study A3921094 or A3921095.
- Clinical response is defined by a decrease from the induction study baseline (A3921094 or A3921095) Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. For eligibility assessment, clinical
response will be determined based on the central-read endoscopy performed at Week 8 of Study A3921094 or A3921095 and the central-read endoscopy performed at Week 0 of Study A3921094 or A3921095.
3. Women of childbearing potential must test negative for pregnancy prior to study enrollment.
- Female subjects of childbearing potential must agree to use a highly effective method
of contraception throughout the study and for at least 4 weeks after the last dose of assigned treatment.
4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, bowel movement diary calls, 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.
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 534
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095.
2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn’s disease.
3. Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.
4. Subjects who are expected to receive any prohibited concomitant medications, including medications that are either moderate to potent CYP3A inducers or inhibitors, during the study period as specified in the protocol.
5. Subjects who are expected to receive live or attenuated virus vaccination during study period and for 6 weeks after last dose of study drug.
6. Women who are pregnant or breastfeeding, or planning to become pregnant during the study period.
7. Baseline 12-lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results (eg baseline QTcF >450 ms, complete LBBB, acute or indeterminate age myocardial infarction, 2nd-3rd degree AV
block, or serious bradyarrhythmias or tachyarrhythmias).
8. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
9. 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.
10. Any 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.
11. Subjects who are participating in or interested in participating in other investigational studies during study A3921096.