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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04090411




Registration number
NCT04090411
Ethics application status
Date submitted
12/09/2019
Date registered
16/09/2019
Date last updated
6/10/2020

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis
Scientific title
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
Secondary ID [1] 0 0
TL1A
Secondary ID [2] 0 0
B7541007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to Severe Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 50 mg
Treatment: Drugs - 450 mg
Treatment: Drugs - 150 mg
Other interventions - 0 mg

Experimental: 450 mg - PF-06480605

Experimental: 150 mg - PF-06480605

Experimental: 50 mg - PF-06480605

Placebo Comparator: 0 mg -


Treatment: Drugs: 50 mg
PF-06480605

Treatment: Drugs: 450 mg
PF-06480605

Treatment: Drugs: 150 mg
PF-06480605

Other interventions: 0 mg
0 mg Placebo

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants achieving clinical remission (defined as a Total Mayo Score =2, with no individual subscore >1) at Week 14. Safety and tolerability will also be assessed
Timepoint [1] 0 0
week 0-14
Primary outcome [2] 0 0
Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period.
Timepoint [2] 0 0
week 0-14
Primary outcome [3] 0 0
Incidence of serious adverse events (SAEs) during the induction period.
Timepoint [3] 0 0
week 0-14
Primary outcome [4] 0 0
Incidence of AEs or SAEs leading to discontinuation during the induction period.
Timepoint [4] 0 0
week 0-14
Primary outcome [5] 0 0
Incidence of clinically significant abnormalities in vital signs, electrocaridograms, (ECGs) and laboratory values during the induction period.
Timepoint [5] 0 0
week 0-14
Secondary outcome [1] 0 0
Proportion of participants achieving remission Food and Drug Administration, ((FDA) definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 14.
Timepoint [1] 0 0
week 0-14
Secondary outcome [2] 0 0
Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore = 0 or 1, =1 point decrease from baseline to achieve a stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) at Week 14.
Timepoint [2] 0 0
week 0-14
Secondary outcome [3] 0 0
Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 14.
Timepoint [3] 0 0
week 0-14
Secondary outcome [4] 0 0
Proportion of participants achieving endoscopic remission (defined as endoscopic subscore = 0) at Week 14.
Timepoint [4] 0 0
week 0-14
Secondary outcome [5] 0 0
PF 06480605 trough concentrations during the induction period through Week 14.
Timepoint [5] 0 0
week 0-14
Secondary outcome [6] 0 0
Change from baseline in fecal calprotectin during the induction period through Week 14.
Timepoint [6] 0 0
week 0-14
Secondary outcome [7] 0 0
Change from baseline in hsCRP during the induction period through Week 14.
Timepoint [7] 0 0
week 0-14
Secondary outcome [8] 0 0
Change from baseline in serum sTL1A during the induction period through Week 14.
Timepoint [8] 0 0
week 0-14
Secondary outcome [9] 0 0
Incidence of development of anti drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14.
Timepoint [9] 0 0
week 0-14

Eligibility
Key inclusion criteria
-

- A diagnosis of UC for =3 months.

- Participants with moderate to severe active UC as defined by a Total Mayo Score of

=6, and an endoscopic subscore of =2.

- Active disease beyond the rectum (>15 cm of active disease from the anal verge at the
screening endoscopy).

- 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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants with a diagnosis of ischemic colitis, infectious colitis, radiation
colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's
disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas,
etc.).

- Participants with an imminent need for surgery or with elective surgery scheduled to
occur during the study

- Chest Radiograph showing abnormalities: 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.

- 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities
that may affect participant safety or interpretation of study results

- Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB
infection.

- Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
State/province [2] 0 0
California
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United States of America
State/province [3] 0 0
Colorado
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United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
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United States of America
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Iowa
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United States of America
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Massachusetts
Country [9] 0 0
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Michigan
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Nevada
Country [11] 0 0
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Ohio
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United States of America
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South Carolina
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Belgium
State/province [17] 0 0
Leuven
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Ruse
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
France
State/province [20] 0 0
Lille Cedex
Country [21] 0 0
France
State/province [21] 0 0
Nantes Cedex 1
Country [22] 0 0
France
State/province [22] 0 0
Pierre-Benite Cedex
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France
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Pierre-Bénite Cedex
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Hungary
State/province [24] 0 0
Veszprem
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Hungary
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Budapest
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Hungary
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Tatabanya
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Hungary
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Vac
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India
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Gujarat
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India
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Karnataka
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India
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Maharashtra
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India
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Rajasthan
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Italy
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Bari
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Italy
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Milan
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Italy
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RM
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Italy
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Verona
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Aomori
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Japan
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Chiba
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Osaka
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Poland
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Dolnoslaskie
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Bialystok
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Knurow
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Sopot
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Szczecin
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Warszawa
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Wroclaw
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Russian Federation
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Stavropol Region
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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Perm
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Russian Federation
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Samara
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Russian Federation
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Tomsk
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Russian Federation
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Tyumen
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Russian Federation
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Yaroslavl
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Slovakia
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Presov
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Slovakia
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Vranov nad Toplou
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Spain
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Madrid
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Thailand
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Bangkok
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Thailand
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Songkhla
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Thailand
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Bangkoknoi
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Turkey
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Ankara
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Istanbul
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Kocaeli
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Mersin
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Turkey
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Zonguldak
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia

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

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04090411
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04090411