Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

Key facts

Study ID

NCT03566823

Run by

Shire

People needed

34

Starts

2018-07-17

Expected to finish

2020-08-18

Last updated by the study team

2021-05-11

Who can join

Age: 16 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must be between greater than or equal to (> =) 16 and less than or equal to (<=) 80 years of age; participants less than (<) 18 years of age must weigh >=40 kg and must have body mass index >=16.5 kilogram per meter square (kg/m\^2)
• Participants must have active moderate to severe ileal (terminal ileum), ileocolic, or colonic CD at baseline (Visit 2) as defined by:
• CDAI score between 220 and 450 (inclusive) AND
• Meeting the following subscores in the 2 item PRO:
• i. Abdominal pain subscore >= 5 (average worst daily pain on the 11 point NRS) and abdominal pain subscore >= 2 (average daily pain on the 4-point abdominal pain variable of CDAI) over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) AND/OR ii. Average of the daily stool frequency subscore >=4 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) c. Presence of ulcerations that are characteristic to CD, as determined by a colonoscopy performed during screening, and as defined by the SES-CD >6 (SES CD >=4 for isolated ileitis) Note that the participant must be confirmed as meeting the CDAI score and PRO subscore requirements before a colonoscopy is done
• Participants must have a documented diagnosis (endoscopic with histology) of CD for >=3 months before screening. Documented diagnosis is defined as:
• A biopsy report in which the description of the histological findings is consistent with the CD diagnosis AND
• A report documenting disease duration based upon prior colonoscopy Note: If a biopsy report is not available in the source document at the time of screening, a biopsy must be performed during the screening colonoscopy and the histology report should be consistent with the CD diagnosis. If the histology description does not support the CD diagnosis at this time point, the participant should not be randomized
• Participants must be willing and able to undergo a colonoscopy during screening after all other inclusion criteria have been met
• Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as sulfasalazine or mesalamine (5-aminosalicylic acid [5-ASA]), glucocorticoids, or immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]) or anti-tumor necrosis factor (anti-TNF). Participants who have had an inadequate response to sulfasalazine or mesalamine should have also failed at least 1 other conventional treatment such as glucocorticoids
• 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
• Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Males and females of reproductive potential who are sexually active must agree to use appropriate contraception (ie, highly effective methods for female and medically appropriate methods for male study participants, for the duration of the study

You may not qualify if…

• Participants with indeterminate colitis, microscopic colitis, nonsteroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of UC
• 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 presence of enterovesical (ie, between the bowel and urinary bladder) or enterovaginal fistulae
• Participants with current symptomatic diverticulitis or diverticulosis
• Participants with clinically significant obstructive colonic stricture, or who have a history of bowel surgery within 6 months before screening, or who are likely to require surgery for CD during the treatment period. Participants who have undergone previous colonic resection or ileocolectomy more than 6 months before screening must have at least 25 cm of colon remaining
• Participants with past medical history of multiple small bowel resections resulting in clinically significant short bowel syndrome
• Participants requiring total parenteral nutrition
• Participants with past medical history of bowel surgery resulting in an existing or current stoma. Participants who had a j-pouch are excluded as a j-pouch could result in a stoma
• Participants have had prior treatment with ontamalimab (formerly PF-00547659; SHP647)
• 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 any nonbiologic treatment with immunomodulatory properties (other than AZA, 6-MP, or MTX) or continuous antibiotics (>2 weeks) for the treatment of CD within 30 days before baseline (Visit 2)
• Participants have received anti-TNF treatment within 60 days before baseline (Visit 2)
• Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline (Visit 2)
• Participants have ever received anti-integrin/adhesion molecule treatment (eg, natalizumab,vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule)
• Participants have received lymphocytes apheresis or selective monocyte granulocytes apheresis within 60 days before baseline (Visit 2)
• Participants have received enteral nutrition treatment within 30 days before baseline (Visit 2)
• Participants have received parenteral or rectal glucocorticoids or rectal 5-ASA within 14 days before screening colonoscopy
• Participants have taken >20 milligram per day(mg/day) of prednisone, >9 mg/day of budesonide, or equivalent oral systemic corticosteroid dose within 14 days before baseline (Visit 2) or have taken >=40 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 6 weeks before baseline (Visit 2)
• Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before screening (Visit 1)
• Participants have received a live (attenuated) vaccine within 30 days before the baseline visit (Visit 2)
• Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis (subjects with C. difficile infection at screening may be allowed retest after treatment), evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the subjects to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit (Visit 2)
• Participants with abnormal chest x-ray or other imaging findings at screening (Visit 1), such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy (A chest x-ray, computed tomography scan, etc, performed up to 12 weeks before study entry [screening, Visit 1] may be used if available; documentation of the official reading must be located and available in the source documentation)
• Participants with evidence of active or latent infection with Mycobacterium tuberculosis (TB) or participants with this history who have not completed a generally accepted full course of treatment before baseline (Visit 2) are excluded all other participants must have either the Mantoux (purified protein derivative [PPD]) tuberculin skin test or interferon-gamma release assay (IGRA) performed
• Participants who have no history of previously diagnosed active or latent TB are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie >= 5 millimeter [mm] induration) or a positive IGRA (the latter to be tested at the site's local laboratory) during screening or within 12 weeks before screening If the IGRA cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor:

Where it is running

• Elite Clinical Studies - Phoenix - Clinedge - PPDS — Phoenix, Arizona, United States
• Advanced Research Center — Anaheim, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Alliance Clinical Research-(Vestavia Hills) — Poway, California, United States
• Care Access Research, San Pablo — San Pablo, California, United States
• Renaissance Research Medical Group, INC — Cape Coral, Florida, United States
• Gastro Florida — Clearwater, Florida, United States
• Alliance Medical Research LLC — Coral Springs, Florida, United States
• SIH Research — Kissimmee, Florida, United States
• Hi Tech and Global Research, LLc — Miami, Florida, United States
• Sanchez Clinical Research, Inc — Miami, Florida, United States
• Crystal Biomedical Research — Miami Lakes, Florida, United States
• Pharma Research International Inc — Naples, Florida, United States
• Bayside Clinical Research - New Port Richey — New Port Richey, Florida, United States
• Accel Research Sites - St. Petersburg - ERN - PPDS — Pinellas Park, Florida, United States
• DBC Research — Tamarac, Florida, United States
• Infinite Clinical Trials — Atlanta, Georgia, United States
• Atlanta Center For Gastroenterology PC — Decatur, Georgia, United States
• Atlanta Gastroenterology Specialists, PC — Suwanee, Georgia, United States
• Loretto Hospital — Chicago, Illinois, United States
• IL Gastroenterology Group — Gurnee, Illinois, United States
• Cotton O'Neil Clinical Research Center — Topeka, Kansas, United States
• Gastroenterology Associates of Hazard — Hazard, Kentucky, United States
• CroNOLA, LLC. — Houma, Louisiana, United States
• Arizona Digestive Health Mesa - East — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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