Phase
Condition
Colic
Infectious Colitis
Gastrointestinal Diseases And Disorders
Treatment
lirentelimab
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Provide written informed consent.
- Completed Study AK002-016, defined as having received 6 infusions of study drug andfollowed through Day 176 (±3) or completed Study AK002-012, defined as having receivedthe cohort-appropriate amount of doses and followed for 5 months after last dose ofstudy drug.
- If patient is on pre-existing dietary restrictions, willingness to maintain thoserestrictions, throughout the study.
- Able and willing to comply with all study procedures.
- Female patients must be either post-menopausal for at least 1 year or surgicallysterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3months, or if of childbearing potential, have a negative pregnancy test and agree touse dual methods of contraception, or abstain from sexual activity until the end ofthe study, or for 120 days following the last dose of study drug, whichever is longer.
- Male patients with female partners of childbearing potential must agree to use ahighly effective method of contraception until the end of the study or for 120 daysfollowing the last dose of study drug, whichever is longer. All fertile men withfemale partners of childbearing potential should be instructed to contact theInvestigator immediately if they suspect their partner might be pregnant at any timeduring study participation.
Exclusion
Key Exclusion Criteria:
- Known hypersensitivity to any constituent of the study drug.
- Any disease, condition (medical or surgical), or cardiac abnormality, which, in theopinion of the Investigator, would place the patient at increased risk.
- Planned or expected vaccination with live attenuated vaccines during the TreatmentPeriod, or vaccination expected within 5 half-lives (4 months) of AK002administration.
- Women who are pregnant, breastfeeding, or planning to become pregnant whileparticipating in the study.
- Any other reason that, in the opinion of the Investigator or Medical Monitor, makesthe patient unsuitable for enrollment.
Study Design
Connect with a study center
Allakos Investigational Site 216-068
Birmingham, Alabama 35209
United StatesSite Not Available
Allakos Investigational Site 216-002
Huntsville, Alabama 35802
United StatesSite Not Available
Allakos Investigational Site
Gilbert, Arizona 85234
United StatesSite Not Available
Allakos Investigational Site
Phoenix, Arizona 85021
United StatesSite Not Available
Allakos Investigational Site 216-035
Phoenix, Arizona 85018
United StatesSite Not Available
Allakos Investigational Site 216-032
Chula Vista, California 91910
United StatesSite Not Available
Allakos Investigational Site 216-014
Santa Monica, California 90404
United StatesSite Not Available
Allakos Investigational Site 216-038
Tustin, California 92780
United StatesSite Not Available
Allakos Investigational Site
Ventura, California 93003
United StatesSite Not Available
Allakos Investigational Site 216-049
Walnut Creek, California 94598
United StatesSite Not Available
Allakos Investigational Site 216-034
Aurora, Colorado 80045
United StatesSite Not Available
Allakos Investigational Site
Brandon, Florida 33511
United StatesSite Not Available
Allakos Investigational Site 216-063
Brandon, Florida 33511
United StatesSite Not Available
Allakos Investigational Site
Edgewater, Florida 32132
United StatesSite Not Available
Allakos Investigational Site 216-027
Edgewater, Florida 32132
United StatesSite Not Available
Allakos Investigational Site
Jacksonville, Florida 32256
United StatesSite Not Available
Allakos Investigational Site 216-056
Jacksonville, Florida 32256
United StatesSite Not Available
Allakos Investigational Site
Miami, Florida 33176
United StatesSite Not Available
Allakos Investigational Site 216-013
Miami, Florida 33176
United StatesSite Not Available
Allakos Investigational Site
New Port Richey, Florida 34653
United StatesSite Not Available
Allakos Investigational Site 216-053
New Port Richey, Florida 34653
United StatesSite Not Available
Allakos Investigational Site 216-007
Chicago, Illinois 60611
United StatesSite Not Available
Allakos Investigational Site
Crowley, Louisiana 70526
United StatesSite Not Available
Allakos Investigational Site 216-001
Crowley, Louisiana 70526
United StatesSite Not Available
Allakos Investigational Site 216-026
Boston, Massachusetts 02111
United StatesSite Not Available
Allakos Investigational Site 216-051
Boston, Massachusetts 02215
United StatesSite Not Available
Allakos Investigational Site 216-052
Boston, Massachusetts 02115
United StatesSite Not Available
Allakos Investigational Site
Rochester, Minnesota 55905
United StatesSite Not Available
Allakos Investigational Site 216-005
Rochester, Minnesota 55905
United StatesSite Not Available
Allakos Investigational Site 216-042
Kansas City, Missouri 64108
United StatesSite Not Available
Allakos Investigational Site
Reno, Nevada 89511
United StatesSite Not Available
Allakos Investigational Site 216-045
Reno, Nevada 89511
United StatesSite Not Available
Allakos Investigational Site
New York, New York 10029
United StatesSite Not Available
Allakos Investigational Site 216-025
New York, New York 10029
United StatesSite Not Available
Allakos Investigational Site
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Allakos Investigational Site 216-020
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Allakos Investigational Site
Durham, North Carolina 27710
United StatesSite Not Available
Allakos Investigational Site 216-048
Durham, North Carolina 27710
United StatesSite Not Available
Allakos Investigational Site 216-050
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Allakos Investigational Site
Cincinnati, Ohio 45231
United StatesSite Not Available
Allakos Investigational Site 216-028
Cincinnati, Ohio 45236
United StatesSite Not Available
Allakos Investigational Site 216-031
Cincinnati, Ohio 45229
United StatesSite Not Available
Allakos Investigational Site
Mentor, Ohio 44060
United StatesSite Not Available
Allakos Investigational Site 216-044
Mentor, Ohio 44060
United StatesSite Not Available
Allakos Investigational Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Allakos Investigational Site 216-021
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Allakos Investigational Site
Chattanooga, Tennessee 37421
United StatesSite Not Available
Allakos Investigational Site 216-003
Chattanooga, Tennessee 37404
United StatesSite Not Available
Allakos Investigational Site 216-006
Chattanooga, Tennessee 37343
United StatesSite Not Available
Allakos Investigational Site 216-011
Chattanooga, Tennessee 37421
United StatesSite Not Available
Allakos Investigational Site
Hixson, Tennessee 37343
United StatesSite Not Available
Allakos Investigational Site
Kingsport, Tennessee 37663
United StatesSite Not Available
Allakos Investigational Site 216-062
Kingsport, Tennessee 37663
United StatesSite Not Available
Allakos Investigational Site
Austin, Texas 78742
United StatesSite Not Available
Allakos Investigational Site 216-022
Austin, Texas 78742
United StatesSite Not Available
Allakos Investigational Site
Ogden, Utah 84405
United StatesSite Not Available
Allakos Investigational Site 216-039
Ogden, Utah 84405
United StatesSite Not Available
Allakos Investigational Site
Salt Lake City, Utah 84132
United StatesSite Not Available
Allakos Investigational Site 216-030
Salt Lake City, Utah 84132
United StatesSite Not Available
Allakos Investigational Site
Sandy, Utah 84092
United StatesSite Not Available
Allakos Investigational Site 216-055
Sandy, Utah 84092
United StatesSite Not Available
Allakos Investigational Site
Spokane, Washington 99202
United StatesSite Not Available
Allakos Investigational Site 216-064
Spokane, Washington 99202
United StatesSite Not Available
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