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Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
COLAL-PRED
Sponsored by
Prometheus Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring colitis, ulcerative, moderate, severe

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Females must be of non-childbearing potential evidenced by being surgically sterile, postmenopausal for at least 12 months or be using acceptable contraception methods such as contraceptive pill, or two forms of barrier contraception.
  • Disease Activity Index (DAI) Score of 6-10 (inclusive) at the Baseline Visit.
  • Previous colonoscopic and biopsy diagnosis of ulcerative colitis with negative evaluation of the ileum within 3 years of the screening visit.
  • Endoscopic evidence of moderate or severe mucosal disease as assessed by flexible sigmoidoscopy, with a minimum confirmed diagnosis of moderate ulcerative colitis.

  • The following concomitant prescription medications for ulcerative colitis are permitted if the following conditions are met:

    1. Oral 5-aminosalicylic acid (5-ASA )therapy if the following 2 criteria are met:

      1. Must be on a stable dose 2 weeks prior to baseline
      2. Must maintain the stable dose until treatment end.

    2. Azathioprine or 6-mercaptopurine or methotrexate if the 4 following criteria are met:

      1. On therapy continually for at least 3 months prior to baseline.
      2. And on a stable dose for at least 2 weeks prior to baseline.
      3. And must maintain the stable dose until the end of study drug treatment.

Exclusion Criteria:

  • History of colonic or rectal surgery, excluding hemorrhoidal surgery or an appendectomy.
  • Pregnant or breast-feeding females.
  • Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney failure, adrenocortical insufficiency, or any other unstable medical condition.
  • Known hypersensitivity to corticosteroids
  • Use of oral 5-aminosalicylic acid (5-ASA) or oral corticosteroids during the immediate screening period.
  • Use of immunosuppressive drugs or antibiotics at any time within four weeks prior to screening.
  • Diagnosis of Crohn's disease; indeterminate colitis; microscopic colitis; ischemic, infectious (e.g., salmonella, shigella, etc.), or amebic colitis; or gonococcal proctitis; Clostridium difficile colitis.
  • History of tuberculosis or HIV
  • Clinically significant abnormal laboratory test results, unless regarded by the Investigator as related to ulcerative colitis
  • History of alcohol or drug abuse
  • Known malignancy or history of malignancy that would reduce life expectancy
  • Recent immunization with live viral vaccines
  • History of or active peptic ulcer disease or gastritis
  • Generalized infections such as systemic fungal or hepatitis B or C
  • History of steroid induced severe hypertension, steroid-induced psychosis, or any other severe steroid-related adverse reaction

Sites / Locations

  • Prometheus Investigational Site #059
  • Prometheus Investigational Site #042
  • Prometheus Investigational Site #081
  • Prometheus Investigational Site #033
  • Prometheus Investigational Site #067
  • Prometheus Investigational Site #090
  • Prometheus Investigational Site #068
  • Prometheus Investigational Site #065
  • Prometheus Investigational Site #093
  • Prometheus Investigational Site 062
  • Prometheus Investigational Site #057
  • Prometheus Investigational Site #060
  • Prometheus Investigational Site #095
  • Prometheus Investigational Site #003
  • Prometheus Investigational Site #022
  • Prometheus Investigational Site #052
  • Prometheus Investigational Site #086
  • Prometheus Investigational Site #097
  • Prometheus Investigational Site #006
  • Prometheus Investigational SIte #036
  • Prometheus Investigational Site #031
  • Prometheus Investigational Site #083
  • Prometheus Investigational Site #023
  • Prometheus Investigational Site #075
  • Prometheus Investigational Site #076
  • Prometheus Investigational Site #007
  • Prometheus Investigational Site #008
  • Prometheus Investigational Site #027
  • Prometheus Investigational Site #066
  • Prometheus Investigational Site #005
  • Prometheus Investigational Site #044
  • Prometheus Investigational Site #010
  • Prometheus Investigational Site 041
  • Prometheus Investigational Site # 001
  • Prometheus Investigational Site #089
  • Prometheus Investigational Site #059
  • Prometheus Investigational Site #015
  • Prometheus Investigational Site #051
  • Prometheus Investigational Site #039
  • Prometheus Investigational Site #061
  • Prometheus Investigational Site 092
  • Prometheus Investigational Site 100
  • Prometheus Investigational Site #016
  • Prometheus Investigational Site #046
  • Prometheus Investigational Site #035
  • Prometheus Investigational Site #025
  • Prometheus Investigational Site #037
  • Prometheus Investigational Site #018
  • Prometheus Investigational Site #091
  • Prometheus Investigational Site # 050
  • Prometheus Investigational Site #011
  • Prometheus Investigational Site #072
  • Prometheus Investigational Site #098
  • Prometheus Investigational Site #021
  • Prometheus Investigational Site #019
  • Prometheus Investigational Site #017
  • Prometheus Investigational Site #014
  • Prometheus Investigational Site #009
  • Prometheus Investigational Site #063
  • Prometheus Investigational Site #080
  • Prometheus Investigational Site #002
  • Prometheus Investigational Site #079
  • Prometheus Investigational Site 043
  • Prometheus Investigational Site 087
  • Prometheus Investigational Site #013
  • Prometheus Investigational Site #047
  • Prometheus Investigational Site #058
  • Prometheus Investigational Site #069
  • Prometheus Investigational Site #070
  • Prometheus Investigational Site #064
  • Prometheus Investigational Site #055
  • Prometheus Investigational Site #094
  • Prometheus Investigational Site #028
  • Prometheus Investigational Site #049
  • Prometheus Investigational Site #030
  • Prometheus Investigational Site #038
  • Prometheus Investigational Site #034
  • Prometheus Investigational Site #045
  • Prometheus Investigational Site #084
  • Prometheus Investigational Site #020
  • Prometheus Investigational Site #053
  • Prometheus Investigational Site #074
  • Prometheus Investigational Site 101
  • Prometheus Investigational Site #071
  • Prometheus Investigational Site #026
  • Prometheus Investigational Site #073
  • Prometheus Investigational Site #082
  • Prometheus Investigational Site #012
  • Prometheus Investigational Site #040

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Arm Description

Outcomes

Primary Outcome Measures

The proportion of patients with Complete Response at Week 4 defined as a decrease from baseline in the DAI score by ≥ 30% or ≥ 3 points, and with a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding sub-score of 0 or 1.

Secondary Outcome Measures

The proportion of patients in Clinical Remission defined as a DAI score of ≤ 2 points, with no-individual DAI sub-score > 1 at Week 4. Patients in remission by this definition will have a rectal bleeding DAI sub-score of either 0 or 1.

Full Information

First Posted
May 9, 2008
Last Updated
September 27, 2010
Sponsor
Prometheus Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00676832
Brief Title
Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis
Official Title
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Prometheus Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether COLAL-PRED is a safe and effective treatment for patients with moderate to severe ulcerative colitis.
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled, parallel-design, dose-ranging study. Eligible patients with a DAI score of 6 to 10 (inclusive), plus endoscopic evidence of moderate to severe ulcerative colitis as assessed by flexible sigmoidoscopy, unless colonoscopy is clinically indicated, and rectal bleeding will be randomized to placebo or one of four doses of COLAL-PRED (equivalent to 40, 60, 80, or 120 mg of prednisolone). The effectiveness and safety of COLAL-PRED will be evaluated at baseline, and after 2 weeks and 4 weeks of treatment. Additional follow-up measurements will take place 7 days post cessation of treatment. The systemic absorption of COLAL-PRED will be determined by measuring blood levels of prednisolone, prednisolone sodium metasulfobenzoate (PMSBS) and metasulfobenzoate at Week 4. Hypothalamic-pituitary-adrenocortical (HPA) axis response will be monitored by measuring morning serum cortisol levels at Baseline, Week 2, Week 4, and at follow-up visit and cortisol levels following adrenocorticotrophic hormone (ACTH) stimulation testing at Baseline and Week 4.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
colitis, ulcerative, moderate, severe

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Title
Group 2
Arm Type
Experimental
Arm Title
Group 3
Arm Type
Experimental
Arm Title
Group 4
Arm Type
Experimental
Arm Title
Group 5
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
prednisolone sodium metasulfobenzoate (PMSBS)
Intervention Description
Placebo solid capsule dosage form administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
COLAL-PRED
Other Intervention Name(s)
prednisolone sodium metasulfobenzoate (PMSBS)
Intervention Description
The study is a double-blinded and results have not been unblinded. Patients were randomized to one of four doses. A solid capsule dosage form was administered orally once daily at doses of 40 mg, 60 mg, 80 mg, or 120 mg.
Primary Outcome Measure Information:
Title
The proportion of patients with Complete Response at Week 4 defined as a decrease from baseline in the DAI score by ≥ 30% or ≥ 3 points, and with a decrease in the rectal bleeding subscore of ≥ 1 or an absolute rectal bleeding sub-score of 0 or 1.
Time Frame
Week 4 of the study or at time of withdrawal
Secondary Outcome Measure Information:
Title
The proportion of patients in Clinical Remission defined as a DAI score of ≤ 2 points, with no-individual DAI sub-score > 1 at Week 4. Patients in remission by this definition will have a rectal bleeding DAI sub-score of either 0 or 1.
Time Frame
Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Females must be of non-childbearing potential evidenced by being surgically sterile, postmenopausal for at least 12 months or be using acceptable contraception methods such as contraceptive pill, or two forms of barrier contraception. Disease Activity Index (DAI) Score of 6-10 (inclusive) at the Baseline Visit. Previous colonoscopic and biopsy diagnosis of ulcerative colitis with negative evaluation of the ileum within 3 years of the screening visit. Endoscopic evidence of moderate or severe mucosal disease as assessed by flexible sigmoidoscopy, with a minimum confirmed diagnosis of moderate ulcerative colitis. The following concomitant prescription medications for ulcerative colitis are permitted if the following conditions are met: Oral 5-aminosalicylic acid (5-ASA )therapy if the following 2 criteria are met: Must be on a stable dose 2 weeks prior to baseline Must maintain the stable dose until treatment end. Azathioprine or 6-mercaptopurine or methotrexate if the 4 following criteria are met: On therapy continually for at least 3 months prior to baseline. And on a stable dose for at least 2 weeks prior to baseline. And must maintain the stable dose until the end of study drug treatment. Exclusion Criteria: History of colonic or rectal surgery, excluding hemorrhoidal surgery or an appendectomy. Pregnant or breast-feeding females. Diagnosis of diabetes, heart failure, unstable angina, hepatic cirrhosis, kidney failure, adrenocortical insufficiency, or any other unstable medical condition. Known hypersensitivity to corticosteroids Use of oral 5-aminosalicylic acid (5-ASA) or oral corticosteroids during the immediate screening period. Use of immunosuppressive drugs or antibiotics at any time within four weeks prior to screening. Diagnosis of Crohn's disease; indeterminate colitis; microscopic colitis; ischemic, infectious (e.g., salmonella, shigella, etc.), or amebic colitis; or gonococcal proctitis; Clostridium difficile colitis. History of tuberculosis or HIV Clinically significant abnormal laboratory test results, unless regarded by the Investigator as related to ulcerative colitis History of alcohol or drug abuse Known malignancy or history of malignancy that would reduce life expectancy Recent immunization with live viral vaccines History of or active peptic ulcer disease or gastritis Generalized infections such as systemic fungal or hepatitis B or C History of steroid induced severe hypertension, steroid-induced psychosis, or any other severe steroid-related adverse reaction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David T. Rubin, M.D.
Organizational Affiliation
The University of Chicago Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prometheus Investigational Site #059
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Prometheus Investigational Site #042
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Prometheus Investigational Site #081
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Prometheus Investigational Site #033
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Prometheus Investigational Site #067
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Prometheus Investigational Site #090
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Prometheus Investigational Site #068
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Prometheus Investigational Site #065
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Prometheus Investigational Site #093
City
Lowell
State/Province
Arkansas
ZIP/Postal Code
72745
Country
United States
Facility Name
Prometheus Investigational Site 062
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Prometheus Investigational Site #057
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Prometheus Investigational Site #060
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Prometheus Investigational Site #095
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Prometheus Investigational Site #003
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
Prometheus Investigational Site #022
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Prometheus Investigational Site #052
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Prometheus Investigational Site #086
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Prometheus Investigational Site #097
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Prometheus Investigational Site #006
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Prometheus Investigational SIte #036
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Prometheus Investigational Site #031
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Prometheus Investigational Site #083
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Prometheus Investigational Site #023
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
Prometheus Investigational Site #075
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
Prometheus Investigational Site #076
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Prometheus Investigational Site #007
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Prometheus Investigational Site #008
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Prometheus Investigational Site #027
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Prometheus Investigational Site #066
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32708
Country
United States
Facility Name
Prometheus Investigational Site #005
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Prometheus Investigational Site #044
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Prometheus Investigational Site #010
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Prometheus Investigational Site 041
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Prometheus Investigational Site # 001
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Prometheus Investigational Site #089
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Prometheus Investigational Site #059
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46016
Country
United States
Facility Name
Prometheus Investigational Site #015
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Prometheus Investigational Site #051
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Prometheus Investigational Site #039
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Prometheus Investigational Site #061
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Prometheus Investigational Site 092
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70005
Country
United States
Facility Name
Prometheus Investigational Site 100
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Prometheus Investigational Site #016
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Prometheus Investigational Site #046
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Prometheus Investigational Site #035
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Prometheus Investigational Site #025
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Prometheus Investigational Site #037
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Prometheus Investigational Site #018
City
Braintree
State/Province
Massachusetts
ZIP/Postal Code
02184
Country
United States
Facility Name
Prometheus Investigational Site #091
City
Southbridge
State/Province
Massachusetts
ZIP/Postal Code
01550
Country
United States
Facility Name
Prometheus Investigational Site # 050
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Prometheus Investigational Site #011
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Prometheus Investigational Site #072
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Prometheus Investigational Site #098
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Prometheus Investigational Site #021
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Prometheus Investigational Site #019
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Prometheus Investigational Site #017
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Prometheus Investigational Site #014
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
Country
United States
Facility Name
Prometheus Investigational Site #009
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Prometheus Investigational Site #063
City
Ocean
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Prometheus Investigational Site #080
City
Brooklyn
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Prometheus Investigational Site #002
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Prometheus Investigational Site #079
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Prometheus Investigational Site 043
City
Rockville Center
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Prometheus Investigational Site 087
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Prometheus Investigational Site #013
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Prometheus Investigational Site #047
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Prometheus Investigational Site #058
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Prometheus Investigational Site #069
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Prometheus Investigational Site #070
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Prometheus Investigational Site #064
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Prometheus Investigational Site #055
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Prometheus Investigational Site #094
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Prometheus Investigational Site #028
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Prometheus Investigational Site #049
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Prometheus Investigational Site #030
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Prometheus Investigational Site #038
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Prometheus Investigational Site #034
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Prometheus Investigational Site #045
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Prometheus Investigational Site #084
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Prometheus Investigational Site #020
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Prometheus Investigational Site #053
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Prometheus Investigational Site #074
City
Union City
State/Province
Tennessee
ZIP/Postal Code
38261
Country
United States
Facility Name
Prometheus Investigational Site 101
City
Denton
State/Province
Texas
ZIP/Postal Code
76201
Country
United States
Facility Name
Prometheus Investigational Site #071
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Prometheus Investigational Site #026
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Prometheus Investigational Site #073
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Prometheus Investigational Site #082
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Prometheus Investigational Site #012
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Prometheus Investigational Site #040
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

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