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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001259-18 | EudraCT Number |
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Trial not started; change in Sponsor, a new trial to be registered by the new Sponsor
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | PF-06480605 150 mg |
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| Treatment Group 2 | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Product | Drug | PF-06480605 150 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with endoscopic response 50 | Endoscopy response 50 (SES-CD50) is defined as a reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at least 50% or more. SES-CD score assesses the presence of ulcers, the percentage of ulcerated surface, the percentage of affected surface, and the presence of narrowing using scales ranging from 0 to 3 in each following bowel segment: Ileum, right colon, transverse colon, left colon, rectum. The score ranges from 0 to 60 with higher score indicating more severe disease. | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission | Clinical remission is defined as CDAI < 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D000742 | Anemia, Dyserythropoietic, Congenital |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Participants are assigned to one of two groups in parallel for the duration of the study
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| Placebo |
| Drug |
Placebo |
|
| Week 14 |
| Proportion of participants achieving endoscopic remission | Endoscopic remission is defined as SES-CD < 4 and at least 2-point reduction versus Baseline and no individual subscore > 1 | Week 14 |
| Proportion of participants achieving endoscopic mucosal healing | Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD | Week 14 |
| The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170 | Inflammatory Bowel Disease Questionnaire (IBDQ) score ranges from 32 to 224. A higher score indicates better quality of life. A score of at least 170 corresponds to clinical remission. | Week 14 |
| Proportion of participants achieving endoscopic response | Endoscopic response defined as improvement of SES-CD score at least 50% from baseline | Week 52 |
| Proportion of participants with a CDAI clinical remission | Clinical remission is defined as CDAI < 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity. | Week 52 |
| Proportion of participants achieving endoscopic remission | Endoscopic remission is defined as SES-CD < 4 and at least 2-point reduction versus Baseline and no individual subscore > 1 | Week 52 |
| Proportion of participants achieving endoscopic mucosal healing | Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD | Week 52 |
| Proportion of participants with a CDAI clinical remission | CDAI < 150 overtime during induction treatment period | up to week 52 |
| Proportion of participants with a CDAI clinical response | As defined by a decrease from baseline in CDAI score of at least 100 points or more | Up to week 52 |
| Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response | PRO2 clinical response is define by improvement in number of liquid/soft stool frequency and abdominal pain score at least 30% from baseline | Up to week 52 |
| Proportion of participants achieving PRO2 clinical remission | PRO2 clinical remission is defined as SF≤2.5 and AP≤1 | Up to week 52 |
| Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG. | up to week 52 |
| Incidence of development of severe and serious infections | Up to week 52 |
| D007410 | Intestinal Diseases |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |