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Small Molecule

PF-06651600 for Crohn's Disease

Phase 2

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline of extension period (week 12) to week 68

Awards & highlights

Study Summary

This trial is testing two different drugs to treat plaque psoriasis. One group of patients will receive one drug for 12 weeks, then the other drug for 52 weeks. The other group of patients will receive the other drug for 12 weeks, then the first drug for 52 weeks.

Eligible Conditions

Crohn's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline of extension period (week 12) to week 68

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline of extension period (week 12) to week 68

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline of extension period (week 12) to week 68 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects with electrocardiogram findings of potential clinical importance

Number of subjects with laboratory tests findings of potential clinical importance

Number of subjects with vital signs findings of potential clinical importance

+1 more

Secondary outcome measures

Mean change from baseline in SES-CD score at Week 12.

Number of participants with potentially clinically important serious infections findings

Number of subjects with adverse events

+11 more

Side effects data

From 2022 Phase 2 trial • 460 Patients • NCT04413617

SARS-CoV-2 test positive

Urinary tract infection

Nausea

Headache

Nasopharyngitis

Arthralgia

Rheumatoid arthritis

Coronavirus infection

Skin squamous cell carcinoma recurrent

Uterine leiomyoma

100%

80%

60%

40%

20%

Study treatment Arm

Tofacitinib 11mg MR

PF-06651600 100mg

PF-06650833 400mg MR

PF-06650833 400mg MR + Tofacitinib 11mg MR

PF-06650833 400mg MR + PF-06651600 100mg

Trial Design

2Treatment groups

Experimental Treatment

Group I: PF-06700841 or placeboExperimental Treatment2 Interventions

Group II: PF-06651600 or placeboExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-06651600 Placebo

2018

Completed Phase 2

~250

PF-06651600

2019

Completed Phase 2

~1900

Placebo PF-06700841

2018

Completed Phase 2

~250

PF-06700841

2018

Completed Phase 2

~2120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,578 Previous Clinical Trials

10,923,207 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,484 Previous Clinical Trials

8,099,284 Total Patients Enrolled

Media Library

PF-06651600 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT03395184 — Phase 2

Crohn's Disease Research Study Groups: PF-06700841 or placebo, PF-06651600 or placebo

Crohn's Disease Clinical Trial 2023: PF-06651600 Highlights & Side Effects. Trial Name: NCT03395184 — Phase 2

PF-06651600 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03395184 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its stamp of approval to PF-06651600?

"Despite a lack of evidence establishing efficacy, PF-06651600 was rated a 2 on our safety scale due to existing clinical data that indicate it is safe."

Answered by AI

How many participants have been accepted into this research project?

"Unfortunately, this clinical trial is no longer recruiting participants. It was initially posted on February 2nd 2018 and most recently updated September 21st 2022. If you are seeking other medical studies, there are presently 252 trials accepting patients with ileocolitis and 5 trials looking for volunteers to join their PF-06651600 study."

Answered by AI

How many operational centers are overseeing this investigation?

"Presently, 30 medical centres are in the process of enrollment for this trial. Sites such as Treasure Valley Medical Research from Boise, CIUSSS de l'Est-de-l'Ile-de-Montreal Installation Hopital Maisonneuve-Rosemont in Montreal and Lonestar Endoscopy LLP located in Southlake are amongst these locations."

Answered by AI

Are there still vacancies in this clinical trial?

"As reported on clinicaltrials.gov, this trial is not presently enrolling participants as it was last updated in September of 2022. Nonetheless, there are still 257 other studies seeking enrollees at this time."

Answered by AI

Is the age criterion for this trial inclusive of persons aged fifty and above?

"As specified by the trial's entry requirements, individuals aged 18 or over and 75 or below are eligible for enrollment."

Answered by AI

Does this research seek to explore untested concepts?

"As of now, Pfizer has sponsored 5 separate trials for PF-06651600 across 210 cities and 40 nations. The initial trial occurred in 2018 with 246 participants that finished the Phase 2 drug approval process. Since then, 39 additional tests have been executed."

Answered by AI

What is the eligibility criteria for participating in this clinical trial?

"In order to be eligible for this medical trial, potential participants must have ileocolitis and fall within the age range of 18-75. The study is currently attempting to enroll a total of 246 patients."

Answered by AI

Could you please enumerate the research projects that have used PF-06651600?

"Investigated since 2018, PF-06651600 has been subject to 39 completed trials. At present there are 5 additional clinical trails accommodating participants; many of these originating in Boise, Idaho and centred around the Samodzielny Publiczny Zespół Opieki Zdrowotnej Pracownia Endoskopii facility."

Answered by AI

Recent research and studies

sJournal

Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of ((s)-2,2-difluorocyclopropyl)((1r,5s)-3-(2-((1-methyl-1h-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841)

Fensome, Andrew, Catherine M. Ambler, Eric Arnold, Mary Ellen Banker, Matthew F. Brown, Jill Chrencik, James D. Clark, et al.. 2018. “Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of ((s)-2,2-difluorocyclopropyl)((1r,5s)-3-(2-((1-methyl-1h-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841)”. Journal of Medicinal Chemistry. American Chemical Society (ACS). doi:10.1021/acs.jmedchem.8b00917.

clinicaltrials.govStudy

Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease

2018. "Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF-06700841 In Subjects With Moderate To Severe Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03395184.