A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)

A 14 Week Phase 2b, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Efficacy, Safety and Tolerability of TEV-48574 in Adult Patients With Ulcerative Colitis or Crohn's Disease (RELIEVE UCCD)

The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and endoscopic response (CD) at week 14.

Secondary objectives:

• To evaluate the efficacy and dose response of the 2 different dose regimens as assessed by multiple standard measures
• To evaluate the safety and tolerability of the 2 different dose regimens
• To evaluate the immunogenicity of the 2 different dose regimens

The study will consist of a screening period of up to 6 weeks (42 days), a 14-week treatment period, and a 4-week follow-up period.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Colitis, Ulcerative
• Intervention / Treatment: Drug: Placebo; Drug: TEV-48574

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Teva U.S. Medical Information; Phone Number: 1-888-483-8279; Email: USMedInfo@tevapharm.com

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • Teva Investigational Site 37134
  • Liege, Belgium, 4000
    • Not yet recruiting
    • Teva Investigational Site 37133
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Recruiting
    • Teva Investigational Site 59198
  • Sofia, Bulgaria, 1680
    • Recruiting
    • Teva Investigational Site 59199
  • Sofia, Bulgaria, 1618
    • Active, not recruiting
    • Teva Investigational Site 59197
  • Sofia, Bulgaria, 1784
    • Active, not recruiting
    • Teva Investigational Site 59196
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3P 1W7
      • Recruiting
      • Teva Investigational Site 11257
  • Ontario
    • Toronto, Ontario, Canada, M5T 3A9
      • Recruiting
      • Teva Investigational Site 11259
• Czechia
  • Brno, Czechia, 63600
    • Recruiting
    • Teva Investigational Site 54221
  • Klatovy, Czechia, 339 01
    • Not yet recruiting
    • Teva Investigational Site 54222
  • Slany, Czechia, 27401
    • Recruiting
    • Teva Investigational Site 54220
• France
  • Caen cedex, France, 14033
    • Recruiting
    • Teva Investigational Site 35280
  • Nice Cedex 3, France, 06200
    • Recruiting
    • Teva Investigational Site 35277
  • Saint Etienne, France, 42055
    • Recruiting
    • Teva Investigational Site 35279
• Germany
  • Berlin, Germany, 10318
    • Not yet recruiting
    • Teva Investigational Site 32796
  • Kiel, Germany, 24105
    • Recruiting
    • Teva Investigational Site 32793
  • Tuebingen, Germany, 72076
    • Not yet recruiting
    • Teva Investigational Site 32795
• Hungary
  • Budapest, Hungary, 1033
    • Recruiting
    • Teva Investigational Site 51335
  • Budapest, Hungary, 1088
    • Recruiting
    • Teva Investigational Site 51334
  • Gyongyos, Hungary, 3200
    • Recruiting
    • Teva Investigational Site 51336
  • Szekesfehervar, Hungary, 8000
    • Not yet recruiting
    • Teva Investigational Site 51333
  • Vac, Hungary, 2600
    • Recruiting
    • Teva Investigational Site 51338
• Israel
  • Afula, Israel, 18101
    • Recruiting
    • Teva Investigational Site 80179
  • Beer Sheva, Israel, 8410101
    • Recruiting
    • Teva Investigational Site 80191
  • Kfar-Sava, Israel, 4428164
    • Recruiting
    • Teva Investigational Site 80182
  • Rechovot, Israel, 761001
    • Recruiting
    • Teva Investigational Site 80180
• Italy
  • Rozzano, Italy, 20089
    • Recruiting
    • Teva Investigational Site 30284
• Japan
  • Fukuoka-shi, Japan, 814-0180
    • Recruiting
    • Teva Investigational Site 84112
  • Kashiwa-shi, Japan, 277-0871
    • Recruiting
    • Teva Investigational Site 84110
  • Minato-ku, Japan, 108-8642
    • Recruiting
    • Teva Investigational Site 84117
  • Mitaka-shi, Japan, 181-8611
    • Recruiting
    • Teva Investigational Site 84115
  • Nagoya-shi, Japan, 457-8511
    • Recruiting
    • Teva Investigational Site 84118
  • Osaka-shi, Japan, 530-0011
    • Recruiting
    • Teva Investigational Site 84113
  • Sakura-shi, Japan, 285-8741
    • Recruiting
    • Teva Investigational Site 84114
  • Shinjuku-ku, Japan, 169-0073
    • Recruiting
    • Teva Investigational Site 84116
  • Toyama-shi, Japan, 930-8550
    • Recruiting
    • Teva Investigational Site 84111
• Norway
  • Lorenskog, Norway, 1474
    • Recruiting
    • Teva Investigational Site 41015
  • Tromso, Norway, 9038
    • Recruiting
    • Teva Investigational Site 41014
• Poland
  • Krakow, Poland, 31-506
    • Recruiting
    • Teva Investigational Site 53512
  • Leczna, Poland, 21-010
    • Recruiting
    • Teva Investigational Site 53511
  • Lodz, Poland, 90-752
    • Recruiting
    • Teva Investigational Site 53515
  • Lodz, Poland, 91-495
    • Recruiting
    • Teva Investigational Site 53514
  • Nowy Targ, Poland, 34-400
    • Recruiting
    • Teva Investigational Site 53518
  • Poznan, Poland, 60-529
    • Recruiting
    • Teva Investigational Site 53516
  • Poznan, Poland, 61-293
    • Recruiting
    • Teva Investigational Site 53517
  • Rzeszow, Poland, 35-326
    • Recruiting
    • Teva Investigational Site 53513
  • Staszow, Poland, 28-200
    • Not yet recruiting
    • Teva Investigational Site 53551
  • Szczecin, Poland, 71-434
    • Recruiting
    • Teva Investigational Site 53508
  • Szczecin, Poland, 71-685
    • Recruiting
    • Teva Investigational Site 53519
  • Warszawa, Poland, 00-728
    • Not yet recruiting
    • Teva Investigational Site 53555
  • Wroclaw, Poland, 52-416
    • Recruiting
    • Teva Investigational Site 53510
  • Zamosc, Poland, 22-400
    • Recruiting
    • Teva Investigational Site 53509
• Serbia
  • Presov, Serbia, 08001
    • Not yet recruiting
    • Teva Investigational Site 62097
• Slovakia
  • Bardejov, Slovakia, 08501
    • Recruiting
    • Teva Investigational Site 62074
  • Bratislava, Slovakia, 811 09
    • Recruiting
    • Teva Investigational Site 62073
  • Kosice, Slovakia, 040 13
    • Recruiting
    • Teva Investigational Site 62071
  • Presov, Slovakia, 08001
    • Recruiting
    • Teva Investigational Site 62076
  • Sahy, Slovakia, 93601
    • Recruiting
    • Teva Investigational Site 62072
• Spain
  • Huelva, Spain, 21005
    • Recruiting
    • Teva Investigational Site 31293
  • Santiago de Compostela, Spain, 15702
    • Not yet recruiting
    • Teva Investigational Site 31318
  • Sevilla, Spain, 41017
    • Recruiting
    • Teva Investigational Site 31291
  • Valencia, Spain, 46026
    • Recruiting
    • Teva Investigational Site 31292
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • Recruiting
    • Teva Investigational Site 58327
  • Ivano-Frankivsk, Ukraine, 76008
    • Recruiting
    • Teva Investigational Site 58324
  • Lviv, Ukraine, 79007
    • Recruiting
    • Teva Investigational Site 58329
  • Lviv, Ukraine, 79010
    • Recruiting
    • Teva Investigational Site 58332
  • Lviv, Ukraine, 79059
    • Recruiting
    • Teva Investigational Site 58325
  • Ternopil, Ukraine, 46002
    • Recruiting
    • Teva Investigational Site 58328
  • Uzhgorod, Ukraine, 88018
    • Recruiting
    • Teva Investigational Site 58322
  • Uzhhorod, Ukraine, 88000
    • Recruiting
    • Teva Investigational Site 58323
  • Vinnytsia, Ukraine, 21008
    • Recruiting
    • Teva Investigational Site 58331
  • Vinnytsia, Ukraine, 21029
    • Recruiting
    • Teva Investigational Site 58330
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Teva Investigational Site 34305
• United States
  • California
    • San Diego, California, United States, 92103
      • Recruiting
      • Teva Investigational Site 15556
    • San Diego, California, United States, 92103
      • Recruiting
      • Teva Investigational Site 15747
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Active, not recruiting
      • Teva Investigational Site 15357
    • Miami, Florida, United States, 33136
      • Recruiting
      • Teva Investigational Site 15365
    • Miami, Florida, United States, 33176
      • Recruiting
      • Teva Investigational Site 15748
    • Miami, Florida, United States, 33032
      • Recruiting
      • Teva Investigational Site 15563
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Teva Investigational Site 15375
    • Tampa, Florida, United States, 33626
      • Recruiting
      • Teva Investigational Site 15359
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Recruiting
      • Teva Investigational Site 15566
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Recruiting
      • Teva Investigational Site 15575
    • New Albany, Indiana, United States, 47150
      • Recruiting
      • Teva Investigational Site 15574
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • Teva Investigational Site 15362
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • Teva Investigational Site 15367
    • Leawood, Kansas, United States, 66214
      • Recruiting
      • Teva Investigational Site 15358
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • Teva Investigational Site 15368
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Active, not recruiting
      • Teva Investigational Site 15363
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Recruiting
      • Teva Investigational Site 15744
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Teva Investigational Site 15373
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Recruiting
      • Teva Investigational Site 15369
  • New York
    • North Massapequa, New York, United States, 11758-1802
      • Recruiting
      • Teva Investigational Site 15558
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7080
      • Recruiting
      • Teva Investigational Site 15370
  • Ohio
    • Dayton, Ohio, United States, 45415
      • Recruiting
      • Teva Investigational Site 15750
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Recruiting
      • Teva Investigational Site 15557
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Recruiting
      • Teva Investigational Site 15573
  • Texas
    • Austin, Texas, United States, 78748
      • Recruiting
      • Teva Investigational Site 15360
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Teva Investigational Site 15371
    • Garland, Texas, United States, 75044
      • Recruiting
      • Teva Investigational Site 15569
    • Harlingen, Texas, United States, 78550
      • Recruiting
      • Teva Investigational Site 15559
    • Katy, Texas, United States, 77494
      • Recruiting
      • Teva Investigational Site 15366
    • Lubbock, Texas, United States, 79424
      • Recruiting
      • Teva Investigational Site 15743
    • Pearland, Texas, United States, 77584
      • Recruiting
      • Teva Investigational Site 15372
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Teva Investigational Site 15374
    • Southlake, Texas, United States, 76092
      • Recruiting
      • Teva Investigational Site 15565
    • Southlake, Texas, United States, 76092
      • Recruiting
      • Teva Investigational Site 15567
    • Southlake, Texas, United States, 76092
      • Recruiting
      • Teva Investigational Site 15568
    • Tyler, Texas, United States, 75701
      • Recruiting
      • Teva Investigational Site 15361
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Recruiting
      • Teva Investigational Site 15364
  • Washington
    • Vancouver, Washington, United States, 98664
      • Not yet recruiting
      • Teva Investigational Site 15560

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for ≥3 months
• The participant is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study
• The participant is able to understand the nature of the study and any potential hazards associated with participating in the study
• Women of non-childbearing potential who are either surgically (documented hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or congenitally sterile as assessed by a physician, or 1-year postmenopausal
• Male participants (including vasectomized) with women of childbearing potential (WOCBP) partners (whether pregnant or not) must use condoms after the first investigational medicinal product (IMP) administration and throughout the study or until 50 days after the last IMP dose, whichever is longer

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• The participant has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study as judged by the investigator and/or the clinical study physician
• Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic coliti
• Participant has colonic dysplasia or neoplasia, toxic megacolon, primary sclerosing cholangitis, known non-passable colonic stricture, presence of colonic or small bowel stoma, presence of non-passable colonic or small bowel obstruction or resection preventing the endoscopy procedure, or fulminant colitis
• Presence of active enteric infections (positive stool culture) or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks prior to the first screening visit
• Participant anticipates requiring major surgery during this study.
• A participant is Hepatitis B core antibody or surface antigen positive and/or Hepatitis C antibody positive with detectable ribonucleic acids, or positive human immunodeficiency virus types 1 or 2 at screening.
• A history of an opportunistic infection (eg, cytomegalovirus retinitis, Pneumocystis carinii, or aspergillosis)
• A history of more than 2 herpes zoster episode in the last 5 years or multimetameric herpes zoster
• A history of or ongoing chronic or recurrent serious infectious disease (eg, infected indwelling prosthesis or osteomyelitis)
• The participant is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.
• Presence of a transplanted organ
• A history of malignancy within the last 5 years (exception: basal cell carcinoma or in situ carcinoma of the cervix if successful curative therapy occurred at least 12 months prior to screening) or curatively resected papillary thyroid cance
• Current or history (within 2 years) of serious psychiatric disease or alcohol or drug abuse
• Participants with incurable diseases, persons in nursing homes, and participants incapable of giving written informed consent

NOTE- Additional criteria apply, please contact the investigator for more information

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEV-48574 Dose A (UC); Dose regimen A administered by subcutaneous infusion for participants with UC	Drug: TEV-48574; Subcutaneous infusion
Experimental: TEV-48574 Dose B (UC); Dose regimen B administered by Subcutaneous infusion for participants with UC	Drug: TEV-48574; Subcutaneous infusion
Experimental: TEV-48574 Dose A (CD); Dose regimen A administered by subcutaneous infusion for participants with CD	Drug: TEV-48574; Subcutaneous infusion
Experimental: TEV-48574 Dose B (CD); Dose regimen B administered by subcutaneous infusion for participants with CD	Drug: TEV-48574; Subcutaneous infusion
Placebo Comparator: Placebo UC; Matching Placebo	Drug: Placebo; Matching Placebo
Placebo Comparator: Placebo CD; Matching Placebo	Drug: Placebo; Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with moderate to severe UC who show clinical remission as defined by the Mayo score	Clinical remission is a modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points, which is defined by: stool frequency subscore of 0 or 1,; rectal bleeding subscore of 0, and; endoscopic subscore of 0 or 1, where a score of 1 does not include "friability" Each parameter of the score ranges from 0 (normal or inactive disease) to 3 (severe activity) and the total score from 0 to 9, respectively	Week 14
Number of participants with moderate to severe CD who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease	Endoscopic response defined as a reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from baseline	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with moderate to severe UC with a clinical response as defined by a decrease from baseline in Mayo score	Clinical response at week 14, defined as a decrease from baseline in the modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1	Baseline and Week 14
Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score	Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1	Week 14
Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score	Endoscopic remission defined as a Mayo endoscopic subscore of 0	Week 14
Number of participants with moderate to severe CD in clinical remission as defined by CDAI score	Clinical remission defined as a CDAI score less than 150	Week 14
Number of participants with moderate to severe CD with an Endoscopic response as defined by the Modified Multiplier-Simple Endoscopic Score (MM-SES-CD)	Endoscopic response defined as a decrease from baseline in Modified Multiplier-Simple Endoscopic Score (MM-SES-CD) of >50%. The MM-SES-CD takes into account the chances of each parameter (presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures) achieving endoscopic remission.	Baseline and Week 14
Number of Participants Who Experience Adverse Events	Adverse events include clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions.	Baseline up to Week 18
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events		Up to Week 18
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)		Baseline, Weeks 2, 4, 8, 14, and 18
Number of ADA positive participants with the presence of neutralizing ADA		Weeks 2, 4, 8, 14, and 18
Number of participants with moderate to severe UC with a clinical response as defined as a decrease from baseline in 2-item patient-reported outcome (PRO2)	Clinical response defined as decrease from baseline of at least 50% in 2-item patient-reported outcome (PRO2; rectal bleeding and stool frequency)	Baseline and Week 14
Number of participants with moderate to severe UC in Clinical remission as defined by PRO2 score	Clinical remission defined as score of rectal bleeding = 0 and stool frequency = 0 on the PRO2 scale	Week 14
Number of participants with moderate to severe CD with a clinical response with a decrease from baseline in Crohn's Disease Activity Index (CDAI)	Clinical response defined as a ≥100-point decrease in CDAI score	Baseline, Weeks 4, 8, 12 and 14
Number of participants with moderate to severe CD with a clinical response as defined by PRO2 score	Clinical response defined as a decrease from baseline of at least 50% in PRO2 (PRO2 is defined as having 2 components, abdominal pain and stool frequency)	Baseline and Week 14
Number of participants with moderate to severe CD in clinical remission as defined by PRO2 score	Clinical remission defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2 scale	Week 14

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Estimated): December 16, 2024
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: August 11, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Crohn Disease; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: TV48574-IMM-20036; 2021-006881-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No