| CTRI Number |
CTRI/2020/07/026827 [Registered on: 27/07/2020] Trial Registered Prospectively |
| Last Modified On: |
07/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Other |
|
Public Title of Study
|
A Study of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis |
|
Scientific Title of Study
|
A phase 2B, multicenter, randomized, double-blind, placebo-controlled dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics of PF-06480605 in adult participants with moderate to severe ulcerative colitis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2019-002698-74 |
EudraCT |
| B7541007 (Final Protocol Amendment 2, 01 Sep 2020) |
Protocol Number |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Karan Thakkar |
| Designation |
Site Relationship and Excellence Partner |
| Affiliation |
Pfizer Limited |
| Address |
Global Site & Study Operations, Clinical Development & Operations, Pfizer Global Product Development,
Pfizer Limited, The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (E), Mumbai, MAHARASHTRA, 400051, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
7045788858 |
| Fax |
|
| Email |
karan.thakkar@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Director (Site Relationship and Excellence Partner) |
| Affiliation |
Pfizer Limited |
| Address |
Global Site & Study Operations, Clinical Development & Operations, Pfizer Global Product Development,
Pfizer Limited, The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (E), Mumbai, MAHARASHTRA, 400051, India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8826422322 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
|
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Source of Monetary or Material Support
|
| Pfizer Inc., 235 East 42nd Street, New York, NY 10017 |
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Primary Sponsor
|
| Name |
Pfizer Inc |
| Address |
235 East 42nd Street
New York
NY 10017 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Pfizer Limited |
The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra(E), Mumbai 400051, INDIA |
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Countries of Recruitment
|
Australia
Austria
Belarus
Belgium
Bulgaria
China
Colombia
France
Germany
Hungary
India
Italy
Japan
Kazakhstan
Mexico
Poland
Romania
Russian Federation
Serbia
Slovakia
South Africa
Spain
Thailand
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Kedia |
All India Institute of Medical Sciences |
Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI |
9868428535
dr.saurabhkedia@yahoo.com |
| Dr Saumin Shah |
Gujarat Hospital – Gastro and Vascular Centre |
Opposite Shree Ram Petrol Pump, Anand Mahal Road, Adajan, Surat, Gujarat, Pin-395009, India
Surat
GUJARAT |
9408042224
dr.sauminpshah@gmail.com |
| Dr Shiran Shetty |
Kasturba Medical College and Hospital |
Department of Gastroenterology,
MAHE, Manipal-576 104, Karnataka, India
Udupi
KARNATAKA |
8861920517
drshiran@gmail.com |
| Dr Avinash Balekuduru |
M.S. Ramaiah Medical College and Hospitals |
M.S. Ramaiah Nagar, MSRIT Post, Bangalore – 560054
Bangalore
KARNATAKA |
8023601923
Avinashbalekuduru@gmail.com |
| Dr Mukesh Kalla |
S. R. Kalla Memorial Gastro and General Hospital |
78-79, Dhuleshwar Garden, C-Scheme, Behind HSBC Bank, Sardar Patel Marg, Jaipur-302001, Rajasthan, India
Jaipur
RAJASTHAN |
9829050622
drmkalla@rediffmail.com |
| Dr Chetan Nalin Metha |
Shree Giriraj Multispecialty Hospital |
Clinical Trial Department, 27 – Navjyot Park Corner, 150 Feet Ring Road, Rajkot-360005, Gujarat, India
Rajkot
GUJARAT |
9825077472
mehtacn@hotmail.com |
| Dr Sandeep Nijhawan |
SMS Medical College and Hospital |
J.L.N. Marg, Jaipur-302 004, Rajasthan, India
Jaipur
RAJASTHAN |
9829272233
drnijhawansandeep@gmail.com |
| Dr Rajiv Manhar Mehta |
Surat Institute of Digestive Sciences |
Vijay Nagar Gate No-3, Besides Nirman Bhavan, Opposite Gandhi College, Surat-395002, Gujarat, India
Surat
GUJARAT |
9879863510
rmgastro@yahoo.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee, M.S. Ramaiah Medical College and Hospitals |
Approved |
| Ethics Committee, SMS Medical College and Hospital |
Approved |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
| MAHE Ethics Committee |
Approved |
| S. R. Kalla Memorial Ethical Committee for Human Research |
Approved |
| Shree Giriraj Hospital Research Ethics Committee |
Approved |
| Surat Institute of Digestive Sciences EC |
Approved |
| Unity Hospital Ethics Committee, Gujarat Hospital Gastro and Vascular Centre |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K510||Ulcerative (chronic) pancolitis, (2) ICD-10 Condition: K512||Ulcerative (chronic) proctitis, (3) ICD-10 Condition: K513||Ulcerative (chronic) rectosigmoiditis, (4) ICD-10 Condition: K515||Left sided colitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PF 06480605 |
Doses of 50 mg, 150 mg, and 450 mg PF-06480605 or Placebo will be administered through 4 treatment arms in a 12-week induction phase. After the induction phase, doses of 50 mg, 150 mg, and 450 mg PF-06480605 will be administered through 3 treatment arms in a 40-week chronic therapy phase |
| Comparator Agent |
Placebo |
Doses of 50 mg, 150 mg, and 450 mg PF-06480605 or Placebo will be administered through 4 treatment arms in a 12-week induction phase. After the induction phase, doses of 50 mg, 150 mg, and 450 mg PF-06480605 will be administered through 3 treatment arms in a 40-week chronic therapy phase |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
(1) A diagnosis of UC for ≥3 months.
(2)Participants with moderate to severe active UC as defined by a Total Mayo Score of ≥6, and an endoscopic subscore of ≥2.
(3)Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
(4)Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors. |
|
| ExclusionCriteria |
| Details |
(1)Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohns disease (eg, skip lesions, fistulae or perianal disease, non necrotizing granulomas, etc.).
(2)Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
(3) Chest Radiograph showing abnormalities i.e. the study will accept a Chest x ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
(4)12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
(5)Infected with tuberculosis i.e. any evidence of untreated latent or active TB infection.
(6)Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses |
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of participants achieving clinical remission (defined as a Total Mayo Score lesser than or equal to 2, with no individual subscore greater than 1) at Week 14. Safety and tolerability will also be assessed.
2.Incidence and severity of treatment emergent adverse events during the induction period.
3.Incidence of serious adverse events during the induction period.
4.Incidence of AEs or SAEs leading to discontinuation during the induction period. |
week 0-14 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Proportion of participants achieving remission Food and Drug Administration, ((FDA) definition 1 - defined as endoscopic subscore equal to 0 or 1, stool frequency subscore equal to 0, and rectal bleeding subscore equal to 0) at Week 14. |
week 0-14 |
| 2.Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore equal to 0 or 1, greater than or equal to 1 point decrease from baseline to achieve a stool frequency subscore equal to 0 or 1, and rectal bleeding subscore equal to 0) at Week 14 |
week 0-14 |
| 3.Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore equal to 0 or 1) at Week 14. |
week 0-14 |
| Proportion of participants achieving endoscopic remission (defined as endoscopic subscore equal to 0) at Week 14 |
week 0-14 |
| 5.PF 06480605 trough concentrations during the induction period through Week 14. |
week 0-14 |
| 6.Change from baseline in fecal calprotectin during the induction period through Week 14. |
week 0-14 |
| 7.Change from baseline in hsCRP during the induction period through Week 14. |
week 0-14 |
| 8.Change from baseline in serum sTL1A during the induction period through Week 14. |
week 0-14 |
| 9.Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14. |
week 0-14 |
|
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Target Sample Size
|
Total Sample Size="240"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/08/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/03/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period. |