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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04090411
Ethics application status
Date submitted
12/09/2019
Date registered
16/09/2019
Date last updated
19/01/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults 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 - Induction- PF-06480605 50 mg SC Q4W
Treatment: Drugs - Induction- PF-06480605 150 mg SC Q4W
Treatment: Drugs - Induction- PF-06480605 450 mg SC Q4W
Other interventions - Induction- Placebo SC Q4W
Treatment: Drugs - Chronic- PF-06480605 50 mg SC Q4W
Treatment: Drugs - Chronic- PF-06480605 150 mg SC Q4W
Treatment: Drugs - Chronic- PF-06480605 450 mg SC Q4W

Experimental: Cohort 1 - Induction - Placebo SC Q4W, (sub-cutaneous every 4 weeks) Chronic- PF-06480605 50 mg SC Q4W

Experimental: Cohort 2 - Induction - Placebo SC Q4W, Chronic- PF-06480605 150 mg SC Q4W

Experimental: Cohort 3 - Induction - Placebo SC Q4W, Chronic- PF-06480605 450 mg SC Q4W

Placebo comparator: Cohort 4 - Induction- PF-06480605 50 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W

Experimental: Cohort 5 - Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W

Experimental: Cohort 6 - Induction- PF-06480605 150 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W

Experimental: Cohort 7 - Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 50 mg SC Q4W

Experimental: Cohort 8 - Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 150 mg SC Q4W

Experimental: Cohort 9 - Induction- PF-06480605 450 mg SC Q4W, Chronic- PF-06480605 450 mg SC Q4W


Treatment: Drugs: Induction- PF-06480605 50 mg SC Q4W
PF-06480605

Treatment: Drugs: Induction- PF-06480605 150 mg SC Q4W
PF-06480605

Treatment: Drugs: Induction- PF-06480605 450 mg SC Q4W
PF-06480605

Other interventions: Induction- Placebo SC Q4W
0 mg Placebo

Treatment: Drugs: Chronic- PF-06480605 50 mg SC Q4W
PF-06480605

Treatment: Drugs: Chronic- PF-06480605 150 mg SC Q4W
PF-06480605

Treatment: Drugs: Chronic- PF-06480605 450 mg SC Q4W
PF-06480605
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
Primary outcome [6] 0 0
Incidence and severity of treatment emergent adverse events (TEAEs) during the chronic therapy period.
Timepoint [6] 0 0
Weeks 14-64
Primary outcome [7] 0 0
Incidence of serious adverse events (SAEs) during the chronic therapy period.
Timepoint [7] 0 0
Weeks 14-64
Primary outcome [8] 0 0
Incidence of AEs or SAEs leading to discontinuation during the chronic therapy period.
Timepoint [8] 0 0
Weeks 14-64
Primary outcome [9] 0 0
Incidence of clinically significant abnormalities in vital signs, ECGs and laboratory values during the chronic therapy period.
Timepoint [9] 0 0
Weeks 14-64
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
Secondary outcome [10] 0 0
Proportion of participants achieving clinical remission (defined as a Total Mayo Score >/= to 2, with no individual subscore >1) at Week 56.
Timepoint [10] 0 0
Weeks 14-56
Secondary outcome [11] 0 0
Proportion of participants achieving sustained clinical remission (ie, clinical remission at both Week 14 and Week 56).
Timepoint [11] 0 0
Weeks 14-56
Secondary outcome [12] 0 0
Proportion of participants achieving remission (FDA definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 56.
Timepoint [12] 0 0
Weeks 14-56
Secondary outcome [13] 0 0
Proportion of participants achieving sustained remission-FDA definition 1 (ie, remission-FDA definition 1 at both Week 14 and Week 56).
Timepoint [13] 0 0
Weeks 14-56
Secondary outcome [14] 0 0
Proportion of participants achieving sustained remission-FDA definition 2 (ie, remission-FDA definition 2 at both Week 14 and Week 56).
Timepoint [14] 0 0
Weeks 14-56
Secondary outcome [15] 0 0
Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 56.
Timepoint [15] 0 0
Weeks 14-56
Secondary outcome [16] 0 0
Proportion of participants achieving sustained endoscopic improvement (ie, endoscopic improvement at both Week 14 and Week 56).
Timepoint [16] 0 0
Weeks 14-56
Secondary outcome [17] 0 0
Proportion of participants achieving endoscopic remission (defined as endoscopic sub-score = 0) at Week 56.
Timepoint [17] 0 0
Weeks 14-56
Secondary outcome [18] 0 0
Proportion of participants achieving sustained endoscopic remission (ie, endoscopic remission at both Week 14 and Week 56).
Timepoint [18] 0 0
Weeks 14-56
Secondary outcome [19] 0 0
PF-06480605 concentration from Week 14 through the End of Study Visit.
Timepoint [19] 0 0
Weeks 14-64
Secondary outcome [20] 0 0
Change from Week 14 in fecal calprotectin during the chronic therapy period through the End of Study Visit
Timepoint [20] 0 0
Weeks 14-64
Secondary outcome [21] 0 0
Change from Week 14 in hsCRP during the chronic therapy period through the End of Study Visit.
Timepoint [21] 0 0
Weeks 14-64
Secondary outcome [22] 0 0
Change from week 14 in serum sTL1A during the chronic therapy period through the End of Study Visit.
Timepoint [22] 0 0
Weeks 14-64
Secondary outcome [23] 0 0
Change from baseline through the End of the Study Visit in fecal calprotectin
Timepoint [23] 0 0
weeks 14-64
Secondary outcome [24] 0 0
Change from baseline through the End of the Study Visit in hsCRP.
Timepoint [24] 0 0
Weeks 14-64
Secondary outcome [25] 0 0
Change from baseline through the End of Study Visit in serum sTL1A.
Timepoint [25] 0 0
Weeks 14-64
Secondary outcome [26] 0 0
Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) from Week 14 through the End of Study Visit.
Timepoint [26] 0 0
Weeks 14-64

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2022
Sample size
Target
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
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
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
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
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
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
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
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Michigan
Country [11] 0 0
United States of America
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Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
Bulgaria
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Sofia
Country [21] 0 0
Colombia
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Caldas
Country [22] 0 0
France
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Amiens Cedex 1
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France
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Lille Cedex
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France
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Nantes Cedex 1
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France
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Pierre-Benite Cedex
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France
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Pierre-Bénite Cedex
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Germany
State/province [27] 0 0
Berlin
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Germany
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Halle (Saale)
Country [29] 0 0
Germany
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Halle/Saale
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Hungary
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Veszprem
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Hungary
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Ajka
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Hungary
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Budapest
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Hungary
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Szekszard
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Székesfehérvár
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Hungary
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Tapolca
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Tatabanya
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Hungary
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Veszprém
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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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Naples
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Italy
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RM
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Verona
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Padova
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Aichi
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Chiba
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Fukuoka
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Japan
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Hokkaido
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Japan
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Miyagi
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Japan
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Tokyo
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Mexico
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Jalisco
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Mexico
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Yucatan
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Mexico
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Ciudad de Mexico
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Mexico
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Queretaro
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Poland
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Bialystok
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Poland
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Knurow
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Poland
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Sopot
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Romania
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Bucuresti
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Russian Federation
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Stavropol Region
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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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
Country [76] 0 0
Serbia
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Kragujevac
Country [77] 0 0
Serbia
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Subotica
Country [78] 0 0
Serbia
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Zrenjanin
Country [79] 0 0
Slovakia
State/province [79] 0 0
Nitra
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Slovakia
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Presov
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Slovakia
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Vranov nad Toplou
Country [82] 0 0
South Africa
State/province [82] 0 0
FREE State
Country [83] 0 0
South Africa
State/province [83] 0 0
Gauteng
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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
Country [87] 0 0
Turkey
State/province [87] 0 0
Istanbul
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Turkey
State/province [88] 0 0
Kocaeli
Country [89] 0 0
Turkey
State/province [89] 0 0
Mersin
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Turkey
State/province [90] 0 0
Zonguldak
Country [91] 0 0
Ukraine
State/province [91] 0 0
Kharkiv
Country [92] 0 0
Ukraine
State/province [92] 0 0
Kyiv
Country [93] 0 0
Ukraine
State/province [93] 0 0
Vinnytsia
Country [94] 0 0
Ukraine
State/province [94] 0 0
Zaporizhzhia
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Birmingham
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Middlesex
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Corby
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United Kingdom
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High Wycombe
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United Kingdom
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Northwood
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United Kingdom
State/province [100] 0 0
Nottingham
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Orpington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

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/study/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

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