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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03395184




Registration number
NCT03395184
Ethics application status
Date submitted
5/12/2017
Date registered
10/01/2018

Titles & IDs
Public title
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease
Scientific title
A PHASE 2A, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND OPEN LABEL EXTENSION TREATMENT IN SUBJECTS WITH MODERATE TO SEVERE CROHN'S DISEASE
Secondary ID [1] 0 0
2017-003359-43
Secondary ID [2] 0 0
B7981007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PF-06651600 Placebo
Treatment: Drugs - PF-06651600
Treatment: Drugs - Placebo PF-06700841
Treatment: Drugs - PF-06700841

Experimental: PF-06700841 or placebo -

Experimental: PF-06651600 or placebo -


Treatment: Drugs: PF-06651600 Placebo
12 weeks, followed by PF-06651600, 50 mg once daily (QD) for 52 weeks

Treatment: Drugs: PF-06651600
200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks

Treatment: Drugs: Placebo PF-06700841
12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks

Treatment: Drugs: PF-06700841
60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
Number of Participants With Laboratory Test Abnormalities During OLE Period
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Primary outcome [3] 0 0
Number of Participants According to Categorization of Vital Signs During OLE Period
Assessment method [3] 0 0
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 \[bpm\]).
Timepoint [3] 0 0
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Primary outcome [4] 0 0
Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Primary outcome [5] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Primary outcome [6] 0 0
Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Primary outcome [7] 0 0
Number of Participants With Discontinuations Due to Adverse Events During OLE Period
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks)
Secondary outcome [1] 0 0
Number of Participants With Laboratory Test Abnormalities During Induction Period
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
From start of study intervention on Day 1 up to Week 12
Secondary outcome [2] 0 0
Number of Participants According to Categorization of Vital Signs During Induction Period
Assessment method [2] 0 0
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).
Timepoint [2] 0 0
From start of study intervention on Day 1 up to Week 12
Secondary outcome [3] 0 0
Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
From start of study intervention on Day 1 up to Week 12
Secondary outcome [4] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During Induction Period
Assessment method [4] 0 0
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. 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.
Timepoint [4] 0 0
From start of study intervention on Day 1 up to Week 12
Secondary outcome [5] 0 0
Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During Induction Period
Assessment method [5] 0 0
A 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.
Timepoint [5] 0 0
From start of study intervention on Day 1 up to Week 12
Secondary outcome [6] 0 0
Number of Participants Discontinuation Due to Adverse Events During Induction Period
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
From start of study intervention on Day 1 up to Week 12
Secondary outcome [7] 0 0
Number of Participants With Serious Infections During Induction Period
Assessment method [7] 0 0
Participants were monitored for development of any infection (viral, bacterial and fungal). Serious infections were treated infections that required parenteral antimicrobial therapy and were present with positive pre-treatment culture and required hospitalization for treatment/met other criteria that required the infection to be classified as SAE. An SAE was any untoward medical occurrence at any dose that: resulted in death; is life-threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity/results in congenital anomaly/birth defect. Treated infections were infections that required antimicrobial therapy by any route of administration/required any surgical intervention (e.g., incision and drainage).
Timepoint [7] 0 0
From start of study intervention on Day 1 up to Week 12
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved Clinically Meaningful Endoscopic Improvement (CMEI) (Reduction of >=3 Points From Baseline in SES-CD Score) at Week 12: Induction Period
Assessment method [8] 0 0
CMEI was defined as reduction of \>=3 points from baseline in SES-CD score as assessed by centrally read SES-CD score. Baseline: last measurement prior to first dosing on Day1. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for 4 domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on scale of 0-3, higher scores indicated more severe condition. Presence of ulcers score: 0=none,1=small ulcer: (0.1-0.5cm),2=Large ulcer(0.5-2cm),3=very large ulcer(\>2cm); 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.
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
Mean Change From Baseline in SES-CD Score at Week 12: Induction Period
Assessment method [9] 0 0
Mean change from baseline in SES-CD score at Week 12 analyzed using analysis of covariance(ANCOVA)model with treatment,baseline disease activity/extent as factors, baseline SES CD score as covariate. Baseline=last measurement prior to first dosing on Day 1. Following bowel segments used for calculating SES-CD scores: Ileum,right C,transverse C,left C,rectum. Each segment assessed for four domains:presence of ulcers, ulcerated surface, affected surface,presence of narrowing, each score on a scale of 0-3,higher scores=more severe condition. Presence of ulcers score:0=none,1=small ulcer:(0.1-0.5cm),2=large ulcer(0.5-2cm),3=very large ulcer(\>2 cm);ulcerated surface score:0=none,1=\<10%,2=10-30%,3=\>30%;affected surface score:0=unaffected segment,1=\<50%, 2=50-75%,3=\>75%;presence of narrowing score:0=none,1=single,can be passed,2=multiple can be passed,3=cannot be passed. Total SES CD score=sum of each domain score for all 5 bowel segments,range from 0 to 60,higher score =more severe disease.
Timepoint [9] 0 0
Baseline and Week 12
Secondary outcome [10] 0 0
Percentage of Participants Achieving >=25% Reduction in SES-CD From Baseline (SES-CD 25) at Week 12: Induction Period
Assessment method [10] 0 0
SES CD25 was defined as \>=25% improvement from baseline in SES CD. Baseline was defined as the last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right 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.
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Percentage of Participants Achieving Endoscopic Remission (SES-CD Score of <= 2) at Week 12: Induction Period
Assessment method [11] 0 0
Endoscopic remission was defined as SES-CD score of \<= 2. 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.
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
Percentage of Participants Achieving Mucosal Healing at Week 12: Induction Period
Assessment method [12] 0 0
Mucosal healing was defined as complete absence of ulcers.
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
Percentage of Participants Achieving CMEI at Week 64 Among Participants Who Achieved CMEI Response at Week 12 (Baseline of OLE Period): OLE Period
Assessment method [13] 0 0
CMEI was defined as reduction of \>=3 points from baseline as assessed by centrally read SES CD score. Baseline: last measurement prior to first dosing on Day 1 of Week 12. Following bowel segments were used for calculating SES-CD scores: Ileum, right 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 scale of 0-3, higher scores indicated more severe condition. Presence of ulcers score: 0=none,1=small ulcer: (0.1-0.5 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 0-60, higher score indicating more severe disease.
Timepoint [13] 0 0
Week 64 (Week 52 of OLE period)
Secondary outcome [14] 0 0
Percentage of Participants Achieving SES CD 25 and SES CD 50 at Week 64 Among Participants Who Achieved SES CD 25 and SES CD 50 at Week 12 (Baseline of OLE Period): OLE Period
Assessment method [14] 0 0
SES CD50 and SES CD25: 50% and 25% improvement from baseline, respectively. Baseline: last measurement prior to first dosing on Day 1 of Week 12. Following bowel segments were used for calculating SES-CD scores: Ileum, right 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 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.
Timepoint [14] 0 0
Week 64 (Week 52 of OLE period)

Eligibility
Key inclusion criteria
1. Male and/or female subjects 18 years to 75 years of age
2. Documented diagnosis of ileal, ileocolonic, or colonic CD with a minimum disease duration of 3 months, as determined by endoscopic and histopathology assessment.
3. Endoscopic confirmation of active disease with total SES CD total score of at least 7. For isolated ileal disease, SES CD total score should be at least 4.
4. An average daily liquid/soft stool frequency (SF) greater than or equal to 2.5 or daily abdominal pain (AP) greater than or equal to 2.0.
5. Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD:

•Steroids; Immunosuppressants (azathioprine [AZA], 6 MP, or methotrexate [MTX]); Anti TNF inhibitors (infliximab, adalimumab,certolizumab); Anti integrin inhibitors (eg, vedolizumab); Anti IL 12/23 inhibitor (ustekinumab).
6. Subjects currently receiving the following treatment for CD are eligible providing they have been on stable doses as described below:

* Oral corticosteroids (prednisone or equivalent up to 25 mg/day; budesonide up to 9 mg/day). Stable dose for at least 2 weeks prior to baseline. If oral corticosteroids have been recently discontinued, they must have been stopped at least 2 weeks prior to baseline. Decreases in steroid use due to AEs are allowed.
* Oral 5 ASA or sulfasalazine are allowed providing that the dose is stable for at least 4 weeks prior to baseline.
* Crohn's disease related antibiotics are allowed providing that the dose is stable for at least 4 weeks prior to baseline. If antibiotics are stopped prior to baseline, they must be discontinued at least 4 days prior to baseline.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, ulcerative colitis (UC), or clinical findings suggestive of UC.
2. Presence of active (draining) fistulae or intra abdominal or perineal abscesses.
3. Strictures with obstructive symptoms.
4. Short bowel syndrome.
5. History of bowel perforation requiring surgical intervention within the past 12 months.
6. Previous bowel surgery resulting in an existing stoma. Subjects who have a j pouch are excluded, as a j pouch can result in a stoma.
7. History of bowel surgery within 6 months prior to baseline.
8. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
9. Subjects with primary sclerosing cholangitis.
10. Subjects with evidence of colonic adenomas, dysplasia or neoplasia.
11. Abnormal findings on the chest x ray film such as presence of tuberculosis (TB), general infections, heart failure, or malignancy.
12. Any history of either untreated or inadequately treated latent or active TB infection, current treatment for active or latent TB infection or evidence of currently active TB by chest x ray, residing with or frequent close contact with individual(s) with active TB.
13. Subjects receiving the following therapies within the time period described below or expected to receive any of these therapies during the study period:

1. >9 mg/day of oral budesonide or >25 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 2 weeks prior to baseline.
2. IV, IM (parenteral), or topical (rectal) treatment of 5 ASA or corticosteroid enemas/suppositories within 2 weeks prior to baseline.
3. Azathioprine, 6 mercaptopurine, or methotrexate within 2 weeks prior to baseline.
4. Anti TNF inhibitors (or biosimilars thereof) as described below:

* Infliximab within 8 weeks prior to baseline;
* Adalimumab within 8 weeks prior to baseline;
* Certolizumab within 8 weeks prior to baseline;
5. Anti integrin inhibitors (eg, vedolizumab) within 8 weeks prior to baseline.
6. Ustekinumab within 8 weeks prior to baseline.
7. Interferon therapy within 8 weeks prior to baseline.
8. Subjects with prior treatment with lymphocyte depleting agents/therapies within 1 year prior to baseline (eg, CamPath[alemtuzumab], alkylating agents [eg, cyclophosphamide or chlorambucil], total lymphoid irradiation, etc).
9. Subjects who have received rituximab or other selective B lymphocyte depleting agents within 1 year prior to baseline.
10. Subjects previously receiving leukocyte apheresis, including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.
11. Other marketed immunosuppressants or biologics with immunomodulatory properties within 3 months prior to baseline.
12. Subjects who have received other JAK inhibitors within 3 months prior to baseline.
13. Subjects who have not responded to or have been intolerant of other JAK inhibitors.
14. Other investigational procedures(s) or product(s), such as immunosuppressants used in transplantation (eg, mycophenolate mofetil, cyclosporine, rapamycin, or tacrolimus) or live (attenuated) vaccine within 30 days prior to baseline.

14) Subjects with history of thrombotic event(s), including deep venous thrombosis (DVT), and known inherited conditions that predispose to hypercoagulability.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2023
Sample size
Target
Accrual to date
Final
244
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Mater Misericordiae Ltd - South Brisbane
Recruitment hospital [3] 0 0
Ballarat Base Hospital - Ballarat
Recruitment hospital [4] 0 0
Saint John of God Health Care Inc. - Subiaco
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3350 - Ballarat
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Austria
State/province [15] 0 0
Wien
Country [16] 0 0
Belgium
State/province [16] 0 0
Jette
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Belgium
State/province [18] 0 0
Liége
Country [19] 0 0
Bosnia and Herzegovina
State/province [19] 0 0
Banja Luka
Country [20] 0 0
Canada
State/province [20] 0 0
Manitoba
Country [21] 0 0
Croatia
State/province [21] 0 0
Split
Country [22] 0 0
Croatia
State/province [22] 0 0
Zagreb
Country [23] 0 0
Czechia
State/province [23] 0 0
Horovice
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Czechia
State/province [25] 0 0
Olomouc
Country [26] 0 0
Czechia
State/province [26] 0 0
Strakonice
Country [27] 0 0
Georgia
State/province [27] 0 0
Tbilisi
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Kiel
Country [30] 0 0
Hungary
State/province [30] 0 0
Bekescsaba
Country [31] 0 0
Hungary
State/province [31] 0 0
Budapest
Country [32] 0 0
Hungary
State/province [32] 0 0
Szekszard
Country [33] 0 0
Italy
State/province [33] 0 0
Bari
Country [34] 0 0
Italy
State/province [34] 0 0
BS
Country [35] 0 0
Italy
State/province [35] 0 0
CZ
Country [36] 0 0
Italy
State/province [36] 0 0
MB
Country [37] 0 0
Italy
State/province [37] 0 0
Milan
Country [38] 0 0
Italy
State/province [38] 0 0
Messina
Country [39] 0 0
Italy
State/province [39] 0 0
Padova
Country [40] 0 0
Italy
State/province [40] 0 0
Roma
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Korea, Republic of
State/province [41] 0 0
Korea
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seoul
Country [43] 0 0
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State/province [43] 0 0
Achrafieh
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Lebanon
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El Chouf
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Lebanon
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Saida
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Dolnoslaskie
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Poland
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Poland
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Poland
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Poland
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Knurow
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Poland
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Poland
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Lodz
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Poland
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Lublin
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Poland
State/province [56] 0 0
Piotrkow Trybunalski
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Poland
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Piotrkow Tryunalski
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Poland
State/province [58] 0 0
Poznan
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Poland
State/province [59] 0 0
Pulawy
Country [60] 0 0
Poland
State/province [60] 0 0
Sopot
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Poland
State/province [61] 0 0
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Poland
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Staszow
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Poland
State/province [63] 0 0
Szczecin
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Poland
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Poland
State/province [65] 0 0
Wloclawek
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Poland
State/province [66] 0 0
Wroclaw
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Saint-petersburg
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Sestroretsk
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Stavropol Region
Country [70] 0 0
Russian Federation
State/province [70] 0 0
Udmurt Republic
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Izhevsk
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Moscow
Country [73] 0 0
Russian Federation
State/province [73] 0 0
Novosibirsk
Country [74] 0 0
Russian Federation
State/province [74] 0 0
Omsk
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Pyatigorsk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Saint Petersburg
Country [77] 0 0
Russian Federation
State/province [77] 0 0
Saint-Petersburg
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Samara
Country [79] 0 0
Russian Federation
State/province [79] 0 0
St. Petersburg
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Stavropol
Country [81] 0 0
Saudi Arabia
State/province [81] 0 0
Riyadh
Country [82] 0 0
Serbia
State/province [82] 0 0
Beograd
Country [83] 0 0
Serbia
State/province [83] 0 0
Srbija
Country [84] 0 0
Slovakia
State/province [84] 0 0
Banska Bystrica
Country [85] 0 0
Slovakia
State/province [85] 0 0
Vranov nad Toplou
Country [86] 0 0
South Africa
State/province [86] 0 0
Gauteng
Country [87] 0 0
South Africa
State/province [87] 0 0
Western CAPE
Country [88] 0 0
Spain
State/province [88] 0 0
Cantabria
Country [89] 0 0
Spain
State/province [89] 0 0
Madrid
Country [90] 0 0
Spain
State/province [90] 0 0
Sevilla
Country [91] 0 0
Spain
State/province [91] 0 0
Valencia
Country [92] 0 0
Switzerland
State/province [92] 0 0
Zürich
Country [93] 0 0
Tunisia
State/province [93] 0 0
Tunis
Country [94] 0 0
Turkey
State/province [94] 0 0
Ankara
Country [95] 0 0
Turkey
State/province [95] 0 0
Kocaeli
Country [96] 0 0
Turkey
State/province [96] 0 0
Mersin
Country [97] 0 0
Turkey
State/province [97] 0 0
Zonguldak
Country [98] 0 0
Ukraine
State/province [98] 0 0
Chernivtsi
Country [99] 0 0
Ukraine
State/province [99] 0 0
Kharkiv
Country [100] 0 0
Ukraine
State/province [100] 0 0
Kyiv
Country [101] 0 0
Ukraine
State/province [101] 0 0
Lviv
Country [102] 0 0
Ukraine
State/province [102] 0 0
Vinnytsia
Country [103] 0 0
Ukraine
State/province [103] 0 0
Zaporizhzhia
Country [104] 0 0
United Arab Emirates
State/province [104] 0 0
Dubai

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03395184