A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

A 44-Week Phase 2b Long-Term Extension, RandomizEd, Double-BLind, Study to Determine the Long-Term PharmacokInetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult PatiEnts With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Main Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)

The primary objective of the study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).

Secondary objectives of the study are to:

• evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
• evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD
• evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD

The total duration of participant participation in the study is planned to be up to 66 weeks for each individual participant. The study duration is approximately 37 months.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease; Colitis, Ulcerative
• Intervention / Treatment: Drug: TEV-48574 Dose Regimen A; Drug: TEV-48574 Dose Regiment B

• Study Type: Interventional
• Enrollment (Estimated): 216
• 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

• Austria
  • Innsbruck, Austria, 6020
    • Not yet recruiting
    • Teva Investigational Site 33055
• Belgium
  • Edegem, Belgium, 2650
    • Not yet recruiting
    • Teva Investigational Site 37134
  • Liege, Belgium, 4000
    • Not yet recruiting
    • Teva Investigational Site 37133
• Bulgaria
  • Pleven, Bulgaria, 5800
    • Not yet recruiting
    • Teva Investigational Site 59198
  • Sofia, Bulgaria, 1618
    • Not yet recruiting
    • Teva Investigational Site 59197
  • Sofia, Bulgaria, 1680
    • Not yet recruiting
    • Teva Investigational Site 59199
  • Sofia, Bulgaria, 1784
    • Not yet recruiting
    • Teva Investigational Site 59196
• Czechia
  • Brno, Czechia, 63600
    • Recruiting
    • Teva Investigational Site 54221
  • Slany, Czechia, 27401
    • Not yet recruiting
    • Teva Investigational Site 54220
• France
  • Caen cedex, France, 14033
    • Not yet recruiting
    • Teva Investigational Site 35280
  • Nice Cedex 3, France, 06200
    • Not yet recruiting
    • Teva Investigational Site 35277
  • Saint Etienne, France, 42055
    • Not yet recruiting
    • Teva Investigational Site 35279
• Hungary
  • Budapest, Hungary, 1033
    • Recruiting
    • Teva Investigational Site 51335
  • Budapest, Hungary, 1088
    • Not yet recruiting
    • Teva Investigational Site 51334
  • Gyongyos, Hungary, 3200
    • Not yet recruiting
    • Teva Investigational Site 51336
  • Szekesfehervar, Hungary, 8000
    • Not yet recruiting
    • Teva Investigational Site 51333
  • Vac, Hungary, 2600
    • Not yet recruiting
    • Teva Investigational Site 51338
• Italy
  • Rozzano, Italy, 20089
    • Not yet recruiting
    • Teva Investigational Site 30284
• Japan
  • Fukuoka-shi, Japan, 814-0180
    • Not yet recruiting
    • Teva Investigational Site 84112
  • Kashiwa-shi, Japan, 277-0871
    • Not yet recruiting
    • Teva Investigational Site 84110
  • Minato-ku, Japan, 108-8642
    • Recruiting
    • Teva Investigational Site 84117
  • Nagoya-shi, Japan, 457-8511
    • Not yet recruiting
    • Teva Investigational Site 84118
  • Osaka-shi, Japan, 530-0011
    • Not yet recruiting
    • Teva Investigational Site 84113
  • Sakura-shi, Japan, 285-8741
    • Not yet recruiting
    • Teva Investigational Site 84114
  • Shinjuku-ku, Japan, 169-0073
    • Not yet recruiting
    • Teva Investigational Site 84116
  • Toyama-shi, Japan, 930-8550
    • Not yet recruiting
    • Teva Investigational Site 84111
• Poland
  • Krakow, Poland, 31-506
    • Not yet recruiting
    • Teva Investigational Site 53512
  • Leczna, Poland, 21-010
    • Not yet recruiting
    • Teva Investigational Site 53511
  • Lodz, Poland, 90-752
    • Not yet recruiting
    • Teva Investigational Site 53515
  • Lodz, Poland, 91-495
    • Not yet recruiting
    • Teva Investigational Site 53514
  • Nowy Targ, Poland, 34-400
    • Not yet recruiting
    • Teva Investigational Site 53518
  • Poznan, Poland, 60-529
    • Not yet recruiting
    • Teva Investigational Site 53516
  • Poznan, Poland, 61-293
    • Not yet recruiting
    • Teva Investigational Site 53517
  • Rzeszow, Poland, 35-326
    • Not yet recruiting
    • Teva Investigational Site 53513
  • Szczecin, Poland, 71-434
    • Not yet recruiting
    • Teva Investigational Site 53508
  • Szczecin, Poland, 71-685
    • Not yet recruiting
    • Teva Investigational Site 53519
  • Wroclaw, Poland, 52-416
    • Recruiting
    • Teva Investigational Site 53510
  • Zamosc, Poland, 22-400
    • Not yet recruiting
    • Teva Investigational Site 53509
• Slovakia
  • Bardejov, Slovakia, 08501
    • Not yet recruiting
    • Teva Investigational Site 62074
  • Bratislava, Slovakia, 811 09
    • Not yet recruiting
    • Teva Investigational Site 62073
  • Kosice, Slovakia, 040 13
    • Not yet recruiting
    • Teva Investigational Site 62071
  • Presov, Slovakia, 08001
    • Not yet recruiting
    • Teva Investigational Site 62076
  • Sahy, Slovakia, 93601
    • Not yet recruiting
    • Teva Investigational Site 62072
• Spain
  • Cordoba, Spain, 14004
    • Not yet recruiting
    • Teva Investigational Site 31302
  • Huelva, Spain, 21005
    • Not yet recruiting
    • Teva Investigational Site 31293
  • Santiago de Compostela, Spain, 15702
    • Not yet recruiting
    • Teva Investigational Site 31318
  • Sevilla, Spain, 41017
    • Not yet recruiting
    • Teva Investigational Site 31291
  • Valencia, Spain, 46026
    • Not yet recruiting
    • Teva Investigational Site 31292
• United States
  • California
    • San Diego, California, United States, 92103
      • Not yet recruiting
      • Teva Investigational Site 15556
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Terminated
      • Teva Investigational Site 15357
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • Teva Investigational Site 15365
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Teva Investigational Site 15375
    • Tampa, Florida, United States, 33626
      • Not yet recruiting
      • Teva Investigational Site 15359
  • Kansas
    • Leawood, Kansas, United States, 66214
      • Not yet recruiting
      • Teva Investigational Site 15358
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Not yet recruiting
      • Teva Investigational Site 15363
  • Nevada
    • Las Vegas, Nevada, United States, 89113
      • Recruiting
      • Teva Investigational Site 15369
  • New York
    • North Massapequa, New York, United States, 11758-1802
      • Not yet recruiting
      • Teva Investigational Site 15558
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7080
      • Not yet recruiting
      • Teva Investigational Site 15370
  • Texas
    • Harlingen, Texas, United States, 78550
      • Not yet recruiting
      • Teva Investigational Site 15559
    • Katy, Texas, United States, 77494
      • Not yet recruiting
      • Teva Investigational Site 15366
    • Pearland, Texas, United States, 77584
      • Not yet recruiting
      • Teva Investigational Site 15372
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Teva Investigational Site 15374
    • 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:

• Maintenance Period- Participants who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study.
• Re-induction- Participants who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study

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

Exclusion Criteria:

• Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons)
• 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.
• Participant anticipates requiring major surgery during this study.
• 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.

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEV-48574 Dose Regimen A for Ulcerative Colitis (UC); Administered by subcutaneous infusion for participants with UC	Drug: TEV-48574 Dose Regimen A; Subcutaneous (sc) administration using a commercial sc infusion system
Experimental: TEV-48574 Dose Regimen A for Crohn's Disease (CD); Administered by subcutaneous infusion for participants with CD	Drug: TEV-48574 Dose Regimen A; Subcutaneous (sc) administration using a commercial sc infusion system
Experimental: TEV-48574 Dose Regimen B for Ulcerative Colitis (UC); Administered by subcutaneous infusion for participants with UC	Drug: TEV-48574 Dose Regiment B; Subcutaneous (sc) administration using a commercial sc infusion system
Experimental: TEV-48574 Dose Regimen B for Crohn's Disease (CD); Administered by subcutaneous infusion for participants with CD	Drug: TEV-48574 Dose Regiment B; Subcutaneous (sc) administration using a commercial sc infusion system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score	Clinical remission based on 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"	Week 44
Number of participants with moderate to severe Crohn's disease (CD) who show an endoscopic response as defined by the Endoscopic Score for Crohn's Disease	Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of at least 50% from DRF study baseline at week 44 in participants with CD	Week 44

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with moderate to severe UC with a clinical response as defined by Mayo score	Clinical response at week 44, 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 DRF 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	Week 44
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 44
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 44
Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score	Defined by clinical remission and corticosteroid-free for ≥12 weeks preceding week 44	Week 44
Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index	Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score	Week 44
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 44
Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD	Defined by endoscopic response and corticosteroid-free for ≥12 weeks preceding week 44	Week 44
Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI	Defined by a CDAI score of <150 points and corticosteroid-free for ≥12 weeks preceding week 44	Week 44
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.	Up to Week 48
Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events		Up to Week 48
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)		Weeks 0, 4, 8, 16, 28, 44, and 48
Number of ADA positive participants with the presence of neutralizing ADA		Weeks 0, 4, 8, 16, 28, 44, and 48

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): January 11, 2023
• Primary Completion (Estimated): July 5, 2031
• Study Completion (Estimated): August 2, 2031

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 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-20038; 2022-002593-89 (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