Double-Drug attack on Crohn's: could two biologics be better than one?

NCT ID NCT06045754

Recruiting now Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 5 times

Summary

This study is testing whether combining two different biologic drugs can better control moderate to severe Crohn's disease. One hundred adults will first receive either vedolizumab plus adalimumab or vedolizumab plus ustekinumab. Those who respond well will then switch to vedolizumab alone. The goal is to see if the combination improves bowel healing and symptoms, and if the benefit can be maintained with a single drug.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: vedolizumab (Entyvio), adalimumab (Humira), ustekinumab (Stelara)
What this could lead to: If successful, this could show that combining two targeted therapies is safe and effective for controlling moderate to severe Crohn's disease, and that some patients may then maintain control with just one drug.
What could go wrong: This is a small, early-phase 4 study with only 100 participants, so results may not apply to everyone. Combining two powerful immune-suppressing drugs also raises the risk of serious infections and other side effects.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CROHN'S DISEASE

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

ABP Research Services Corp.
RECRUITING

Oakville, Ontario, L6L 5L7, Canada
Allegheny Health Network
RECRUITING

Wexford, Pennsylvania, 15090, United States
Alliance Clinical Research of Tampa, LLC
RECRUITING

Tampa, Florida, 33615, United States
BVL Clinical Research
RECRUITING

Liberty, Missouri, 64068, United States
Cedars-Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Clinical Research of Osceola
RECRUITING

Kissimmee, Florida, 34741, United States
Cotton ONeil Clinical Research Center
RECRUITING

Topeka, Kansas, 66606, United States
Covenant Health
RECRUITING

Edmonton, Alberta, T5K 2K4, Canada
Digestive Disease Specialists, Inc.
RECRUITING

Oklahoma City, Oklahoma, 73114, United States
Digestive Health Specialsits
RECRUITING

Dothan, Alabama, 36301, United States
Endoscopic Research Inc
RECRUITING

Orlando, Florida, 32803, United States
GI Alliance
RECRUITING

Metairie, Louisiana, 70006, United States
GI Alliance - Digestive Health Associates of Texas
RECRUITING

Dallas, Texas, 75044, United States
GI Alliance - Mansfield
RECRUITING

Mansfield, Texas, 76063, United States
GI Alliance - Webster
RECRUITING

Webster, Texas, 77598, United States
GI Alliance Sun City
RECRUITING

Sun City, Arizona, 85351, United States
Gastro Intestinal Research Institute of Northern Ohio, LLC.
RECRUITING

Westlake, Ohio, 44145, United States
Gastroenterology Consultants, P.C.
RECRUITING

Roswell, Georgia, 30076, United States
Gastroenterology Research of San Antonio, LLC
RECRUITING

San Antonio, Texas, 78229, United States
Great Lakes Gastroenterology Research, LLC
RECRUITING

Mentor, Ohio, 44060, United States
Hoag Hospital Newport Beach
RECRUITING

Newport Beach, California, 92663, United States
Huron Gastroenterology Associates, P.C.
RECRUITING

Ypsilanti, Michigan, 48197, United States
London Health Sciences Centre
RECRUITING

London, Ontario, N6A 5A5, Canada
Medical Research Center of Connecticut, LLC
RECRUITING

Hamden, Connecticut, 06518, United States
Mid-America Gastro-Intestinal Consultants
RECRUITING

Kansas City, Missouri, 64111, United States
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
Ohio Gastroenterology group, Inc.
RECRUITING

Columbus, Ohio, 43202, United States

Contact Email: •••••@•••••
Sanford Health Research
RECRUITING

Rapid City, South Dakota, 57701, United States
Southern Star Research Institute, LLC.
RECRUITING

San Antonio, Texas, 78229, United States
Texas Digestive Disease Consultants (TDDC), Southlake
RECRUITING

Southlake, Texas, 76092, United States
Texas Digestive Disease Consultants Cedar Park
RECRUITING

Cedar Park, Texas, 78613, United States
Texas Digestive Disease Consultants Lubbock
RECRUITING

Lubbock, Texas, 79410, United States
The Research Institute of the McGill University Health Centre
RECRUITING

Montreal, Quebec, H3G 1A4, Canada
The University of Texas Health Science Center at Houston
RECRUITING

Houston, Texas, 77030, United States
Toronto Digestive Disease Associates (TDDA) Inc.
RECRUITING

Vaughan, Ontario, L4L 4Y7, Canada
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
RECRUITING

North York, Ontario, M6A3B4, Canada
Tulane University
RECRUITING

New Orleans, Louisiana, 70112, United States
Tyler Research Institute, LLC
RECRUITING

Tyler, Texas, 75701, United States
University Gastroenterology
RECRUITING

Providence, Rhode Island, 02094, United States
University of California San Diego Health (UCSD)
RECRUITING

La Jolla, California, 92037, United States
University of Chicago Medicine
RECRUITING

Chicago, Illinois, 60637, United States
University of Cincinnati
RECRUITING

Cincinnati, Ohio, 45627, United States
University of Kansas Medical Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Louisville
RECRUITING

Louisville, Kentucky, 40202, United States
University of Utah Health
RECRUITING

Salt Lake City, Utah, 84108, United States
Viable Clinical Research - North Bay
RECRUITING

North Bay, Ontario, P1B 2H3, Canada
Washington Gastroenterology- GIA
RECRUITING

Tacoma, Washington, 98405, United States
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States

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