Trial · NCT03395184
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
NCT03395184, Phase 2, Completed, Pfizer; results first posted 2024-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease. Trials, record NCT03395184. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03395184
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
- NCT number
- NCT03395184
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 244 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Crohn's Disease
- Interventions
- PF-06651600 Placebo, PF-06651600, Placebo PF-06700841, PF-06700841
- First posted
- 2018-01-10
- Last updated
- 2024-10-30
- Other registries' IDs
- eudract:2017-003359-43
- Results first posted
- 2024-10-30
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period | Week 12 | SES CD50 was defined as 50% improvement from baseline in SES-CD. Baseline was defined as last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease. |
| Primary | Number of Participants With Laboratory Test Abnormalities During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | Pre-specified criteria for lab abnormalities included- hematology: hemoglobin(Hb), erythrocytes (ery),hematocrit:\<0.8\*lower limit of normal(LLN);reticulocytes: \<0.5\*LLN, \>1.5\*upper limit of normal(ULN); ery mean corpuscular(EMC) volume: \<0.9\*ULN, \>1.11\*ULN;EMC Hb: \<0.9\*LLN; platelets:\>1.75\*ULN; leukocytes(10\^9/L): \<0.6\*LLN,\>1.5\*ULN;lymphocyte,neutrophil(10\^9/L):\<0.8\*LLN,\>1.2\*ULN;basophil,eosinophil,monocyte(10\^9/L):\>1.2\*ULN;activated partial thromboplastin time (sec): \>1.1\*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)\>3.0\*ULN; protein, albumin(g/dL):\<0.8\*LLN; creatinine, triglycerides (mg/dL):\>1.3\*ULN; urate(mg/dL):\>1.2\*ULN, potassium (mEq/L):\<0.9\*LLN; calcium (mg/dL): \<0.9\*LLN,\>1.1\*ULN. Urinalysis: pH\>8;urine,glucose,protein(mg/dl); ketones, nitrite, urine Hb(scalar):\>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported. |
| Primary | Number of Participants According to Categorization of Vital Signs During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | Vital signs including blood pressure (diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\], and pulse rate \[PR\]) were measured in a supine position using automated devices. DBP included value \< 50 (millimeter of mercury \[mmHg\]), change \>=20 (mmHg) increase and change \>=20 (mmHg) decrease; SBP: value \< 90 (mmHg), change \>= 30 (mmHg) increase and change \>= 30 (mmHg) decrease; PR: value \> 120 (beats per minute \[bpm\]). |
| Primary | Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc \>=480 milli second (msec) or an absolute change in QTc greater than (\>) 60 msec. Clinically significant ECG findings were determined by the investigator. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | An adverse event (AE) was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. An AE was considered TEAE to a given treatment if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. |
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. An SAE was considered as TESAE if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. |
| Primary | Number of Participants With Discontinuations Due to Adverse Events During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. Discontinuations from study due to TEAEs were defined as participants with an AE record indicating the AE caused permanent discontinuation from the study but action taken with study treatment was not drug withdrawn. Permanent discontinuations from any study intervention due to TEAEs were defined as participants with an AE record indicating that action taken with study treatment was drug withdrawn. In this outcome measure number of participants with discontinuation from study due to AEs and permanent discontinuation from study intervention due to AEs are reported. |
| Secondary | Number of Participants With Laboratory Test Abnormalities During Induction Period | From start of study intervention on Day 1 up to Week 12 | Pre-specified criteria for lab abnormalities included- hematology: hemoglobin, erythrocytes, hematocrit:\<0.8\*LLN; reticulocytes: \<0.5\*LLN, \>1.5\*ULN; EMC volume: \<0.9\*ULN, \>1.11\*ULN;EMC Hb: \<0.9\*LLN; platelets:\>1.75\*ULN; leukocytes(10\^9/L): \<0.6\*LLN, \>1.5\*ULN; lymphocyte, neutrophil(10\^9/L):\<0.8\*LLN, \>1.2\*ULN; basophil, eosinophil, monocyte(10\^9/L):\>1.2\*ULN; activated partial thromboplastin time (sec): \>1.1\*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)\>3.0\*ULN; protein, albumin(g/dL):\<0.8\*LLN; creatinine, triglycerides (mg/dL):\>1.3\*ULN; urate(mg/dL):\>1.2\*ULN, potassium (mEq/L):\<0.9\*LLN; calcium (mg/dL): \<0.9\*LLN,\>1.1\*ULN. Urinalysis: pH\>8; urine, glucose, protein(mg/dl); ketones, nitrite, urine Hb(scalar):\>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported. |
| Secondary | Number of Participants According to Categorization of Vital Signs During Induction Period | From start of study intervention on Day 1 up to Week 12 | Vital signs including blood pressure (diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\], and pulse rate \[PR\]) were measured in a supine position using automated devices. DBP included value \< 50 (mmHg), change \>=20 (mmHg) increase and change \>=20 (mmHg) decrease; SBP: value \< 90 (mmHg), change \>= 30 (mmHg) increase and PR: value \> 120 (bpm). |
| Secondary | Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period | From start of study intervention on Day 1 up to Week 12 | Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc greater than or equal to (\>=)480 milli second (msec) or an absolute change in QTc greater than (\>)60 msec. Clinically significant ECG findings were determined by the investigator. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period | Week 12 | FAS included all randomized participants who received at least one dose of the randomized investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | Safety analysis set (SAS) included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Categorization of Vital Signs During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Here Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Discontinuations Due to Adverse Events During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Test Abnormalities During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants According to Categorization of Vital Signs During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here, 'Number Analyzed' signifies number of participants evaluable for specific rows. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period | From start of study intervention on Day 1 up to Week 12 | SAS included all those participants who received at least one dose of the investigational drug (ritlecitinib, brepocitinib, or placebo). Participants who received placebo in induction period were analyzed as a single reporting group. Here Number of Participants Analyzed signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period | Induction Period: Placebo QD | 12.8 | 90% Confidence Interval 7.1 to 19.9 | Percentage of participants | |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period | Induction Period: Ritlecitinib 200 mg/50 mg QD | 27.2 | 90% Confidence Interval 19.6 to 35.7 | Percentage of participants | |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period | Induction Period: Brepocitinib 60 mg QD | 33.8 | 90% Confidence Interval 25.1 to 43.1 | Percentage of participants | |
| Number of Participants With Laboratory Test Abnormalities During OLE Period | OLE Period: Placebo QD -> Ritlecitinib 50 mg QD | 33 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities During OLE Period | OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD | 76 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities During OLE Period | OLE Period: Placebo QD -> Brepocitinib 30 mg QD | 26 | Participants | ||
| Number of Participants With Laboratory Test Abnormalities During OLE Period | OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD | 56 | Participants | ||
| Number of Participants According to Categorization of Vital Signs During OLE Period | OLE Period: Placebo QD -> Ritlecitinib 50 mg QD | DBP; value < 50 (mmHg) | 0 | Participants | |
| Number of Participants According to Categorization of Vital Signs During OLE Period | OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD | DBP; value < 50 (mmHg) | 2 | Participants | |
| Number of Participants According to Categorization of Vital Signs During OLE Period | OLE Period: Placebo QD -> Brepocitinib 30 mg QD | DBP; value < 50 (mmHg) | 0 | Participants |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow42
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Period (Up to 12 Weeks) | STARTED | Induction Period: Placebo QD | 79 | |
| Induction Period (Up to 12 Weeks) | STARTED | Induction Period: Ritlecitinib 200 mg/50 mg QD | 93 | |
| Induction Period (Up to 12 Weeks) | STARTED | Induction Period: Brepocitinib 60 mg QD | 72 | |
| Induction Period (Up to 12 Weeks) | STARTED | OLE Period: Placebo QD -> Ritlecitinib 50 mg QD | 0 | |
| Induction Period (Up to 12 Weeks) | STARTED | OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD | 0 | |
| Induction Period (Up to 12 Weeks) | STARTED | OLE Period: Placebo QD -> Brepocitinib 30 mg QD | 0 | |
| Induction Period (Up to 12 Weeks) | STARTED | OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD | 0 | |
| Induction Period (Up to 12 Weeks) | COMPLETED | Induction Period: Placebo QD | 68 | |
| Induction Period (Up to 12 Weeks) | COMPLETED | Induction Period: Ritlecitinib 200 mg/50 mg QD | 84 | |
| Induction Period (Up to 12 Weeks) | COMPLETED | Induction Period: Brepocitinib 60 mg QD | 65 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 participant flowAdverse events427
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 | Induction Period: Placebo QD | 0 | 79 | |
| other | Anaemia | Blood and lymphatic system disorders | Induction Period: Ritlecitinib 200 mg/50 mg QD | 0 | 93 | |
| other | Anaemia | Blood and lymphatic system disorders | Induction Period: Brepocitinib 60 mg QD | 0 | 72 | |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: Placebo QD -> Ritlecitinib 50 mg QD | 3 | 36 | |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD | 0 | 84 | |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: Placebo QD -> Brepocitinib 30 mg QD | 2 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD | 2 | 64 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Induction Period: Placebo QD | 1 | 79 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Induction Period: Ritlecitinib 200 mg/50 mg QD | 3 | 93 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Induction Period: Brepocitinib 60 mg QD | 4 | 72 |
1 to 10 of 427Source ClinicalTrials.gov
See all 427 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Period: Placebo QD | 0 | 79 |
| Total, all-cause mortality | Induction Period: Ritlecitinib 200 mg/50 mg QD | 0 | 93 |
| Total, all-cause mortality | Induction Period: Brepocitinib 60 mg QD | 0 | 72 |
| Total, all-cause mortality | OLE Period: Placebo QD -> Ritlecitinib 50 mg QD | 0 | 36 |
| Total, all-cause mortality | OLE Period: Ritlecitinib 200 mg/50 mg QD -> Ritlecitinib 50 mg QD | 0 | 84 |
| Total, all-cause mortality | OLE Period: Placebo QD -> Brepocitinib 30 mg QD | 0 | 32 |
| Total, all-cause mortality | OLE Period: Brepocitinib 60 mg QD -> Brepocitinib 30 mg QD | 0 | 64 |
| Total, other adverse events | Induction Period: Placebo QD | 20 | 79 |
| Total, other adverse events | Induction Period: Ritlecitinib 200 mg/50 mg QD | 20 | 93 |
| Total, other adverse events | Induction Period: Brepocitinib 60 mg QD | 17 | 72 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers2
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.
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