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

Last updated on August 21, 2018

FOR MORE INFORMATION
Study Location
Dothan Surgery Center (Colonoscopy and Tissue Biopsy Location)
Dothan, Alabama, 36301 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT03395184
Pfizer
Recruiting
Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF‑06700841 In Subjects With Moderate To Severe Crohn's Disease

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Study To Evaluate The Efficacy And Safety Of Oral PF-06651600 And PF?06700841 In Subjects With Moderate To Severe Crohn's Disease
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
The objectives of this study are to evaluate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06651600 (200 mg for 8 weeks followed by 50 mg for 4 weeks) dosed once daily and PF-06700841 (60 mg for 12 weeks) dosed once daily during an induction period of 12 weeks, followed by an open label extension period at doses of 50 mg and 30 mg of PF 06651600 and PF 06700841, respectively, for 52 weeks.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: Placebo PF-06651600
    12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks
  • Drug: Placebo PF-06700841
    12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.
  • Drug: PF-06651600
    200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks
  • Drug: PF-06700841
    60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks
  • Experimental: PF-06700841 or placebo
    Interventions:
    • Drug: Placebo PF-06700841
    • Drug: PF-06700841
  • Experimental: PF-06651600 or placebo
    Interventions:
    • Drug: Placebo PF-06651600
    • Drug: PF-06651600
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
February 18, 2021
February 4, 2020   (Final data collection date for primary outcome measure)

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, or golimumab, 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.

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;
      • Golimumab 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03395184
B7981007
2017-003359-43 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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