Last updated on March 2020

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis | Crohn's Disease (Pediatric) | Crohn's Disease | Inflammatory bowel disease | Ulcerative Colitis (Pediatric)
  • Age: Between 16 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

Participants with Ulcerative Colitis (UC) Entering from an Induction or Maintenance Study:

  • Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
  • Participants must have been previously enrolled in study SHP647-301 (NCT03259334), SHP647-302 (NCT03259308), or SHP647-303 (NCT03290781), and reached 1 of the following clinical trial milestones:
    1. Completed the Week 12 visit in induction study SHP647-301 or SHP647-302, and did not achieve a clinical response. Clinical response is defined as: 1. a decrease from baseline in the composite score of patient-reported symptoms using daily e-diary and centrally read endoscopy of at least 2 points and at least 30 percent (%), with an accompanying decrease in the subscore for rectal bleeding greater than or equal to (>=) 1 point or a subscore for rectal bleeding less than or equal to (<=) 1, or 2. a decrease from the induction study (SHP647-301 or SHP647-302) baseline total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1.
    2. Completed the Week 52 visit in maintenance study SHP647-303.
    3. Withdrew early from maintenance study SHP647-303 due to treatment failure, defined by an endoscopic subscore that has increased by at least 1 point over baseline in the maintenance study or a value >= 2 plus an increase in clinical subscore (stool frequency + rectal bleeding score) of at least 2 points. Centrally read endoscopic subscores will be used to determine treatment failure.
  • Participants receiving any treatment(s) for UC are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Participants with UC Entering Directly:

Participants who are not entering from an induction or maintenance study (Study SHP647-301, SHP647-302, SHP647-303) must meet all of the following inclusion criteria to be eligible for enrollment into this study.

  • Participants must meet at least 1 of the 3 criteria below:
    1. Have previously received ontamalimab (SHP647) in a Shire or Pfizer-sponsored Phase 1 or Phase 2 clinical trial
    2. Have previously received vedolizumab C. Live in a country that has reached its enrollment cap for induction studies (SHP647-301 and/or SHP647-302).
  • Participants must have a documented diagnosis (radiologic or endoscopic with histology) of UC for >= 3 months before screening. The following must be available in each participant source documentation:
    1. A biopsy report to confirm the histological diagnosis
    2. A report documenting disease duration based upon prior colonoscopy.
  • Participants must be willing to undergo a flexible sigmoidoscopy or colonoscopy (if preferred or required per exclusion criterion 5), during screening after all other inclusion criteria have been met.
  • Participants must have moderate to severe active UC, defined as a total Mayo score of >= 6, including a centrally read endoscopic subscore >= 2, rectal bleeding subscore >= 1, and stool frequency subscore >= 1 at baseline (Visit 1). Subjects must have moderate to severe active UC, evidence of UC extending proximal to the rectum.

Participants with Crohn's Disease:

  • Participants and/or their parent or legally authorized representative must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.
  • Participants must be able to voluntarily provide written, signed, and dated (personally or via a legally authorized representative) informed consent and/or assent, as applicable, to participate in the study.
  • Participants must have been enrolled previously in study SHP647-305 (NCT03559517), SHP647-306 (NCT03566823), or SHP647-307 (NCT03627091) and reached 1 of the following clinical trial milestones:
    1. Completed the Week 16 visit in induction study SHP647-305 or SHP647-306 and did not meet the efficacy criteria (clinical and/or endoscopic response/remission as appropriate) for entry into maintenance study SHP647-307.
    2. Completed the Week 52 visit in maintenance study SHP647-307.
    3. Withdrew early from maintenance study SHP647-307 due to treatment failure (or were considered to have failed treatment, at the time of the last visit in study SHP647-307), as defined in the SHP647-307 protocol.
  • Participants receiving any treatment(s) for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

Participants with UC Entering from an Induction or Maintenance Study:

  • Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-301, SHP647-302, or SHP647-303.
  • Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in study SHP647-301, SHP647-302, or SHP647-303.
  • Participants who are likely to require major surgery for UC.
  • Participants are females who became pregnant during study SHP647-301, SHP647-302, or SHP647-303, females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue using appropriate contraception methods (i.e. highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
  • Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
  • Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.
  • Participants who have a newly-diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).
  • Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [e.g.], renal, hepatic, hematologic, gastrointestinal [except disease under study], endocrine, cardiovascular, pulmonary, immunologic [e.g. Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
  • Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or ECG abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in study SHP647-301 (NCT03259334) or SHP647-302 (NCT03259308) and who have been advised to require treatment for latent or active disease, but who are without a generally accepted course of treatment.
  • Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.
  • Participants who are participating in other investigational studies (other than SHP647-301, SHP647-302, or SHP647-303) or plan to participate in other investigational studies during long-term extension study SHP647-304.

Participants with UC Entering Directly:

Participants are excluded from the study if any of the following criteria are met:

  • Participants with indeterminate colitis, microscopic colitis, nonsteroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of CD.
  • Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed.)
  • Participants with past medical history or presence of toxic megacolon.
  • Participants with colonic stricture, past medical history of colonic resection, a history of bowel surgery within 6 months before screening, or who are likely to require surgery for UC during the treatment period.
  • Participants at risk for colorectal cancer must have a colonoscopy (Eaden and Mayberry, 2002) performed during the screening period with results available within 10 days before the baseline visit (Visit 1), unless the participant has had a surveillance colonoscopy performed within 1 year prior to screening, and any adenomatous polyps found at that examination have been excised. Colonoscopy report and pathology report (if biopsies are obtained) from the colonoscopy performed during screening or in the prior year confirming no evidence of dysplasia and colon cancer must be available in the source documents.
  • Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients.
  • Participants have received anti-TNF treatment within 60 days or vedolizumab within 120 days before baseline (Visit 1).
  • Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline (Visit 1).
  • Participants with any unexplained symptoms suggestive of progressive multifocal leukoencephalopathy based on the targeted neurological assessment during the screening period.
  • Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.
  • Participants who have had significant trauma or major surgery within 4 weeks before the screening visit, or with any major elective surgery scheduled to occur during the study.
  • Participants with evidence of cirrhosis with or without decompensation.
  • Participants with primary sclerosing cholangitis.
  • Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb).

Note: if a participant tests negative for HBsAg, but positive for HBcAb, the participant would be considered eligible if no presence of hepatitis B virus (HBV) DNA is confirmed by HBV DNA polymerase chain reaction reflex testing performed in the central laboratory.

  • Participants with chronic hepatitis C virus (HCV) (positive HCV antibody [HCVAb] and HCV RNA). Note: Participants who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured [defined as no evidence of HCV RNA at least 12 weeks prior to baseline]).
  • Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during screening. Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the participants clinical condition, may be repeated once during the screening period for confirmation. Results must be reviewed for eligibility prior to the screening endoscopy procedure.
    1. Alanine aminotransferase and aspartate aminotransferase levels >= 3.0 the upper limit of normal (ULN)
    2. Total bilirubin level >= 1.5 ULN or > 2.0ULN if the participant has a known documented history of Gilbert's syndrome
    3. Hemoglobin level <= 80 g/L (8.0 g/dL)
    4. Platelet count <= 100 109/L (100,000 cells/mm3) or >= 1000 109/L (1,000,000 cells/mm3)*
    5. White blood cell count <= 3.5 109/L (3500 cells/mm3)
    6. Absolute neutrophil count < 2 109/L (2000 cells/mm3)
    7. Serum creatinine level > 1.5 ULN or estimated glomerular filtration rate < 30 mL/min/1.73m2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.
  • Note: If platelet count is < 150,000 cells/mm3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.
  • Female participants who are planning to become pregnant during the study period.
  • Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.
  • Participants who are investigational site staff members or relatives of those site staff members or participants who are Shire employees directly involved in the conduct of the study.

Participants with Crohn's Disease:

  • Participants who had major protocol deviation(s) (as determined by the sponsor) in study SHP647-305, SHP647-306 or SHP647-307.
  • Participants who permanently discontinued investigational product because of an adverse events (AE), regardless of relatedness to investigational product, in study SHP647-305, SHP647-306 or SHP647-307.
  • Participants who are likely to require major surgery for CD or developed acute severe complications of CD (with or without fulfilling the treatment failure criteria in the maintenance study) that required immediate intervention (e.g. need for immediate biologic treatment with proven effect) and/or Crohn's Disease Activity Index (CDAI) score more than (>) 450.
  • Participants are females who became pregnant during study SHP647-305, SHP647-306 or SHP647-307, females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue appropriate contraception methods (i.e. highly effective methods for female and medically appropriate methods for male study participants) through the conclusion of study participation.
  • Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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