Trial · NCT02958865
Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
NCT02958865, Phase 2, Completed, Pfizer; results first posted 2022-07-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis. Trials, record NCT02958865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02958865
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis
- NCT number
- NCT02958865
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 319 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Ulcerative Colitis
- Interventions
- PF-06651600 or Placebo, PF-06700841 or Placebo, PF-06700841, PF-06651600
- First posted
- 2016-11-08
- Last updated
- 2022-07-21
- Other registries' IDs
- eudract:2016-003708-29
- Results first posted
- 2022-07-21
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Mayo Score at Week 8 (Induction Period) | Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score. |
| Secondary | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | From Week 8 up to Week 32 | An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs. |
| Secondary | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | From Week 8 to Week 32 | The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance. |
| Secondary | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | From Week 8 to Week 32 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant. |
| Secondary | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | From Week 8 to Week 32 | The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below. |
| Secondary | Number of Participants With Abnormal ECG Findings (Chronic Period) | Week 8 to Week 32 | The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below. |
| Secondary | Number of Participants With Serious Infections (Chronic Period) | Week 8 to Week 32 | Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials. |
| Secondary | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Week 8 to Week 32 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL). |
| Secondary | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Week 8 to Week 32 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor. |
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | From Day 1 up to Week 8 | An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Mayo Score at Week 8 (Induction Period) | Week 8 | The intent-to-treat (ITT) analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | From Week 8 up to Week 32 | The safety analysis set was defined as those participants who received at least one dose of PF-06651600, PF-06700841, or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | From Week 8 to Week 32 | The participants with at least one observation of the given laboratory test while on study treatment or during lag time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | From Week 8 to Week 32 | Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | From Week 8 to Week 32 | The participants evaluated against the criteria during the chronic period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal ECG Findings (Chronic Period) | Week 8 to Week 32 | The participants evaluated against the criteria during the chronic period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Infections (Chronic Period) | Week 8 to Week 32 | The participants who received at least one dose of PF-06651600, PF-06700841, or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Week 8 to Week 32 | Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Week 8 to Week 32 | Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | From Day 1 up to Week 8 | The participants who received at least one dose of PF-06651600, PF-06700841, or placebo. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group1,621
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Mayo Score at Week 8 (Induction Period) | Placebo (Induction) | 7.88 | 90% Confidence Interval 6.95 to 8.81 | Units on a scale | |
| Total Mayo Score at Week 8 (Induction Period) | PF-06651600 20 mg (Induction) | 5.85 | 90% Confidence Interval 5.18 to 6.51 | Units on a scale | |
| Total Mayo Score at Week 8 (Induction Period) | PF-06651600 70 mg (Induction) | 4.00 | 90% Confidence Interval 3.33 to 4.67 | Units on a scale | |
| Total Mayo Score at Week 8 (Induction Period) | PF-06651600 200 mg (Induction) | 3.27 | 90% Confidence Interval 2.58 to 3.96 | Units on a scale | |
| Total Mayo Score at Week 8 (Induction Period) | PF-06700841 10 mg (Induction) | 6.08 | 90% Confidence Interval 5.43 to 6.74 | Units on a scale | |
| Total Mayo Score at Week 8 (Induction Period) | PF-06700841 30 mg (Induction) | 5.60 | 90% Confidence Interval 4.93 to 6.27 | Units on a scale | |
| Total Mayo Score at Week 8 (Induction Period) | PF-06700841 60 mg (Induction) | 4.67 | 90% Confidence Interval 4.01 to 5.33 | Units on a scale | |
| Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | PF-06651600 200 mg -> PF-06651600 50 mg | Participants with AEs | 18 | Participants | |
| Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | PF-06651600 70 mg -> PF-06651600 50 mg | Participants with AEs | 27 | Participants | |
| Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | PF-06651600 20 mg -> PF-06651600 50 mg | Participants with AEs | 18 | Participants |
1 to 10 of 1,621Source ClinicalTrials.gov
See all 1,621 results by groupParticipant flow96
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period (Day 1 to Week 8) | STARTED | Placebo (Induction) | 25 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06651600 20 mg (Induction) | 51 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06651600 70 mg (Induction) | 49 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06651600 200 mg (Induction) | 50 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06700841 10 mg (Induction) | 48 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06700841 30 mg (Induction) | 47 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06700841 60 mg (Induction) | 47 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06651600 200 mg -> PF-06651600 50 mg | 0 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06651600 70 mg -> PF-06651600 50 mg | 0 | |
| Induction Period (Day 1 to Week 8) | STARTED | PF-06651600 20 mg -> PF-06651600 50 mg | 0 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 participant flowAdverse events928
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Induction) | 1 | 25 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06651600 20 mg (Induction) | 1 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06651600 70 mg (Induction) | 2 | 49 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06651600 200 mg (Induction) | 4 | 50 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06700841 10 mg (Induction) | 1 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06700841 30 mg (Induction) | 1 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06700841 60 mg (Induction) | 4 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06651600 200 mg -> PF-06651600 50 mg | 1 | 35 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06651600 70 mg -> PF-06651600 50 mg | 0 | 36 | |
| other | Anaemia | Blood and lymphatic system disorders | PF-06651600 20 mg -> PF-06651600 50 mg | 0 | 39 |
1 to 10 of 928Source ClinicalTrials.gov
See all 928 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (Induction) | 0 | 25 |
| Total, all-cause mortality | PF-06651600 20 mg (Induction) | 1 | 51 |
| Total, all-cause mortality | PF-06651600 70 mg (Induction) | 0 | 49 |
| Total, all-cause mortality | PF-06651600 200 mg (Induction) | 0 | 50 |
| Total, all-cause mortality | PF-06700841 10 mg (Induction) | 0 | 48 |
| Total, all-cause mortality | PF-06700841 30 mg (Induction) | 0 | 47 |
| Total, all-cause mortality | PF-06700841 60 mg (Induction) | 0 | 47 |
| Total, all-cause mortality | PF-06651600 200 mg -> PF-06651600 50 mg | 0 | 35 |
| Total, all-cause mortality | PF-06651600 70 mg -> PF-06651600 50 mg | 0 | 36 |
| Total, all-cause mortality | PF-06651600 20 mg -> PF-06651600 50 mg | 0 | 39 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02958865
GET https://conductscience.org/api/trials/v1/NCT02958865/registered?page=2