| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10045282 |
| E.1.2 | Term | UC |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| The primary objective is to demonstrate efficacy of CP-690,550 in inducing a clinical response in subjects with moderate-to-severe ulcerative colitis. |
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| E.2.2 | Secondary objectives of the trial |
| Evaluate the safety and tolerability of oral CP-690,550 in subjects with moderate-tosevere ulcerative colitis. Evaluate the efficacy of CP-690,550 in inducing a clinical remission in subjects with moderate-to-severe ulcerative colitis. Characterize the pharmacokinetics of CP-690,550 in subjects with moderate-to-severe ulcerative colitis. Evaluate the effect of treatment of CP-690,550 on Quality Of Life in subjects with moderate-to-severe ulcerative colitis. Demonstrate the change from baseline in following biomarkers: CRP, fecal calprotectin. |
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| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione:Finale Data:2008/07/21 Titolo:MOLECULAR PROFILING SUPPLEMENT SAMPLES FOR PFIZER’S EXPLORATORY RESEARCH BIOBANK Obiettivi:
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| E.3 | Principal inclusion criteria |
| 1. Subject must be at least 18 years of age. 2. Males and females with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study. 3. Subjects with active moderate to severe ulcerative colitis as defined by Mayo score of ≥6 Subjects with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline. 5. If subjects are currently receiving the following treatment for ulcerative colitis, they are eligible, providing they are on stable dose for the required period of time: Oral 5-ASA or sulfasalazine stable dose for at least 3 weeks prior to baseline and during the study treatment period. AND/OR Oral corticosteroids (prednisolone ≤30 mg/day or less or equivalent) stable dose for at least 2 weeks prior to baseline. 6. Subjects with no evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by the following: A negative Mantoux Purified Protein Derivative (PPD) skin test result (≤5 mm of induration) or negative QuantiFERON TB Gold (QFT Gold test) performed within the 3 months prior to screening (in subjects with a history of Bacille Calmette Gue'rin (BCG) vaccination, QFT Gold test or T-Spot test is strongly recommended). AND A chest radiograph (taken within the 3 months prior to screening) without changes suggestive of active TB infection. AND No history of either untreated or inadequately treated latent or active TB infection. 7. Subjects willing to use double contraception during the study treatment period and until completion of follow-up procedures: If the subject is a sexually active woman of childbearing potential, she and her male partner are required to simultaneously use 2 effective contraceptive methods as listed in Section 4.4.3.2 . Female subjects who wish to use non-hormonal contraception must have done so for at least 14 days prior to the first dose of study medication. Non-vasectomized males with female partners of child bearing potential must be willing to use a condom in addition to having their female partner use another form of contraception as listed in Section 4.4.5. 8. Subjects receiving non-prohibited concomitant medications for any reason, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half lives (whichever is longer) prior to first study dose. Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures. 10. Evidence of a signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study. |
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| E.4 | Principal exclusion criteria |
| 1. Diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn’s disease. 2. Subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less). 3. Treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment). 4. Subjects displaying clinical signs of ischemic colitis, fulminant colitis or toxic megacolon. 5. Subject who have had surgery as a treatment for ulcerative colitis or likely to require surgery during the study period. 6. Subjects who have an evidence of pathogenic bowel infection. 7. Subjects receiving the following therapy: Azathioprine/6-mercaptopurine, methotrexate within 7 days prior to baseline. Cyclosporine, mycophenolate, tacrolimus within 4 weeks prior to baseline. Interferon therapy within 8 weeks prior to baseline. Anti-TNFα therapy within 8 weeks prior to baseline. Intravenous corticosteroids or rectally administered formulation of corticosteroids or 5-ASA within 2 weeks prior to baseline. 8. Subjects with evidence of hematopoietic disorders: Hemoglobin levels <9.0 g/dL or hematocrit <30% at screening visit or within the 3 months prior to baseline. An absolute white blood cell (WBC) count of <3.0 x 109/L (<3000/mm3) or ANC of <1.2 X 109/L (<1200/mm3) at screening visit or within the 3 months prior to baseline. Thrombocytopenia, as defined by a platelet count <100 x 109/L (<100,000/mm3) at screening visit or within the 3 months prior to baseline. 9. Subjects with evidence of total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 2 times the upper limit of normal at screening visit. 10. Subjects with eGFR ≤40 ml/min based on Cockcroft-Gault calculation. 11. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease. 12. Subjects with clinically significant infections currently or within 6 months of baseline (eg those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), or those with a history of more than one episode of herpes zoster, a history (single episode) of disseminated zoster, a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study or any infection requiring antimicrobial therapy within 2 weeks of screening. 13. Subjects who may have current immunization with any live virus vaccine or history of immunization with any live virus vaccine within 8 weeks of baseline. 14. Subjects who may have, during the 8 weeks of treatment and for 8 weeks following completion of study treatment, routine household contact with individuals who have received: a. FluMist (intranasal influenza vaccine) within 1 week of such contact; b. attenuated rotavirus vaccine within 10 days of such contact; c. varicella or attenuated typhoid fever vaccine within 4 weeks of such contact; or d. oral polio vaccine within 6 weeks of such contact. 15. Subjects with a first-degree relative with a hereditary immunodeficiency. 16. History of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder, as reported in some subjects on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| Clinical response at Week 8 (decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1). |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 60 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 8 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 8 |
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