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 of 2 different doses of TEV-48574 as assessed by multiple standard measures
• To evaluate the safety and tolerability of 2 different doses of TEV-48574
• To evaluate the immunogenicity of 2 different dioses of TEV-48574

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

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, 6020
    • Teva Investigational Site 33055
  • Vienna, Austria, 1090
    • Teva Investigational Site 33056
• Belgium
  • Edegem, Belgium, 2650
    • Teva Investigational Site 37134
  • Liège, Belgium, 4000
    • Teva Investigational Site 37133
• Bulgaria
  • Gorna Oryahovitsa, Bulgaria, 5100
    • Teva Investigational Site 59243
  • Pleven, Bulgaria, 5803
    • Teva Investigational Site 59198
  • Sofia, Bulgaria, 1618
    • Teva Investigational Site 59197
  • Sofia, Bulgaria, 1680
    • Teva Investigational Site 59199
  • Sofia, Bulgaria, 1784
    • Teva Investigational Site 59196
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Teva Investigational Site 11257
• Czechia
  • Brno, Czechia, 615 00
    • Teva Investigational Site 54221
  • Klatovy, Czechia, 339 01
    • Teva Investigational Site 54222
  • Prague, Czechia, 140 00
    • Teva Investigational Site 54241
  • Slaný, Czechia, 274 01
    • Teva Investigational Site 54220
  • Zábřeh, Czechia, 78901
    • Teva Investigational Site 54242
• France
  • Caen, France, 14000
    • Teva Investigational Site 35280
  • Nantes, France, 44300
    • Teva Investigational Site 35295
  • Nice, France, 06200
    • Teva Investigational Site 35277
  • Saint-Priest-en-Jarez, France, 42270
    • Teva Investigational Site 35279
• Georgia
  • Tbilisi, Georgia, 0102
    • Teva Investigational Site 81057
  • Tbilisi, Georgia, 0160
    • Teva Investigational Site 81054
  • Tbilisi, Georgia, 0180
    • Teva Investigational Site 81055
  • Tbilisi, Georgia, 0178
    • Teva Investigational Site 81056
  • Tbilisi, Georgia, 0180
    • Teva Investigational Site 81053
  • Tbilisi, Georgia, 0119
    • Teva Investigational Site 81052
• Germany
  • Berlin, Germany, 10318
    • Teva Investigational Site 32796
  • Berlin, Germany, 12559
    • Teva Investigational Site 32872
  • Duisburg, Germany, 47055
    • Teva Investigational Site 32873
  • Kiel, Germany, 24105
    • Teva Investigational Site 32793
  • Leipzig, Germany, 04103
    • Teva Investigational Site 32797
  • Tübingen, Germany, 72076
    • Teva Investigational Site 32795
  • Ulm, Germany, 89081
    • Teva Investigational Site 32794
  • Wipperfürth, Germany, 51688
    • Teva Investigational Site 32874
• Hungary
  • Budapest, Hungary, 1085
    • Teva Investigational Site 51334
  • Budapest, Hungary, H-1033
    • Teva Investigational Site 51335
  • Gyöngyös, Hungary, 3200
    • Teva Investigational Site 51336
  • Székesfehérvár, Hungary, H-8000
    • Teva Investigational Site 51333
  • Vác, Hungary, H-2600
    • Teva Investigational Site 51338
• Israel
  • Afula, Israel, 1834111
    • Teva Investigational Site 80179
  • Beersheba, Israel, 8410101
    • Teva Investigational Site 80191
  • Holon, Israel, 58100
    • Teva Investigational Site 80184
  • Kfar Saba, Israel, 4428164
    • Teva Investigational Site 80182
  • Rehovot, Israel, 7661041
    • Teva Investigational Site 80180
• Italy
  • Brescia, Italy, 25123
    • Teva Investigational Site 30304
  • Milan, Italy, 20132
    • Teva Investigational Site 30285
  • Milan, Italy, 20157
    • Teva Investigational Site 30286
  • Rozzano, Italy, 20089
    • Teva Investigational Site 30284
  • San Donato Milanese, Italy, 20097
    • Teva Investigational Site 30303
  • San Giovanni Rotondo, Italy, 71013
    • Teva Investigational Site 30300
  • Turin, Italy, 10128
    • Teva Investigational Site 30301
• Japan
  • Fukuoka, Japan, 814-0180
    • Teva Investigational Site 84112
  • Kashiwa, Japan, 277-0871
    • Teva Investigational Site 84110
  • Minato, Japan, 108-8642
    • Teva Investigational Site 84117
  • Mitaka, Japan, 181-8611
    • Teva Investigational Site 84115
  • Nagoya, Japan, 457-8511
    • Teva Investigational Site 84118
  • Osaka, Japan, 530-0011
    • Teva Investigational Site 84113
  • Sakura, Japan, 285-8741
    • Teva Investigational Site 84114
  • Shinjuku, Japan, 169-0073
    • Teva Investigational Site 84116
  • Toyama, Japan, 930-8550
    • Teva Investigational Site 84111
• Norway
  • Lorenskog, Norway, 1478
    • Teva Investigational Site 41015
  • Tromsø, Norway, 9038
    • Teva Investigational Site 41014
• Poland
  • Bydgoszcz, Poland, 85-794
    • Teva Investigational Site 53565
  • Częstochowa, Poland, 42-202
    • Teva Investigational Site 53542
  • Elblag, Poland, 82-300
    • Teva Investigational Site 53543
  • Gdansk, Poland, 80-382
    • Teva Investigational Site 53544
  • Gdynia, Poland, 81-537
    • Teva Investigational Site 53545
  • Jelenia Góra, Poland, 58-500
    • Teva Investigational Site 53571
  • Katowice, Poland, 40-040
    • Teva Investigational Site 53546
  • Krakow, Poland, 30-363
    • Teva Investigational Site 53560
  • Krakow, Poland, 31-156
    • Teva Investigational Site 53548
  • Krakow, Poland, 31-506
    • Teva Investigational Site 53512
  • Kłodzko, Poland, 57-300
    • Teva Investigational Site 53547
  • Lodz, Poland, 90-752
    • Teva Investigational Site 53515
  • Lodz, Poland, 91-495
    • Teva Investigational Site 53514
  • Nowy Targ, Poland, 34-400
    • Teva Investigational Site 53518
  • Opole, Poland, 45-819
    • Teva Investigational Site 53559
  • Piotrkow Trybunalski, Poland, 97-300
    • Teva Investigational Site 53572
  • Poznan, Poland, 60-529
    • Teva Investigational Site 53516
  • Poznan, Poland, 60-702
    • Teva Investigational Site 53566
  • Poznan, Poland, 60-324
    • Teva Investigational Site 53517
  • Poznan, Poland, 54-144
    • Teva Investigational Site 53549
  • Poznan, Poland, 54-144
    • Teva Investigational Site 53563
  • Rzeszów, Poland, 35-326
    • Teva Investigational Site 53513
  • Sopot, Poland, 81-756
    • Teva Investigational Site 53550
  • Staszów, Poland, 28-200
    • Teva Investigational Site 53551
  • Szczecin, Poland, 71-434
    • Teva Investigational Site 53508
  • Szczecin, Poland, 71-685
    • Teva Investigational Site 53519
  • Tarnów, Poland, 33-100
    • Teva Investigational Site 53552
  • Tarnów, Poland, 33-100
    • Teva Investigational Site 53573
  • Torun, Poland, 87-100
    • Teva Investigational Site 53553
  • Wadowice, Poland, 34-100
    • Teva Investigational Site 53554
  • Warsaw, Poland, 00-189
    • Teva Investigational Site 53557
  • Warsaw, Poland, 02-672
    • Teva Investigational Site 53570
  • Warsaw, Poland, 02-786
    • Teva Investigational Site 53556
  • Warsaw, Poland, 04-501
    • Teva Investigational Site 53555
  • Wroclaw, Poland, 50-381
    • Teva Investigational Site 53558
  • Wroclaw, Poland, 52-416
    • Teva Investigational Site 53510
  • Wroclaw, Poland, 53-149
    • Teva Investigational Site 53567
  • Wroclaw, Poland, 53-673
    • Teva Investigational Site 53520
  • Wroclaw, Poland, 53-611
    • Teva Investigational Site 53562
  • Zamość, Poland, 22-400
    • Teva Investigational Site 53509
  • Łęczna, Poland, 21-010
    • Teva Investigational Site 53511
• Slovakia
  • Banská Bystrica, Slovakia, 975 17
    • Teva Investigational Site 62098
  • Bardejov, Slovakia, 085 01
    • Teva Investigational Site 62074
  • Bratislava, Slovakia, 811 09
    • Teva Investigational Site 62073
  • Košice, Slovakia, 040 13
    • Teva Investigational Site 62071
  • Prešov, Slovakia, 080 01
    • Teva Investigational Site 62076
  • Prešov, Slovakia, 080 01
    • Teva Investigational Site 62097
  • Rimavská Sobota, Slovakia, 979 01
    • Teva Investigational Site 62099
  • Šahy, Slovakia, 936 01
    • Teva Investigational Site 62072
• Spain
  • Alicante, Spain, 03010
    • Teva Investigational Site 31325
  • Córdoba, Spain, 14004
    • Teva Investigational Site 31302
  • Huelva, Spain, 21005
    • Teva Investigational Site 31293
  • Las Palmas de Gran Canaria, Spain, 35010
    • Teva Investigational Site 31301
  • Santiago de Compostela, Spain, 15702
    • Teva Investigational Site 31318
  • Seville, Spain, 41009
    • Teva Investigational Site 31291
  • Valencia, Spain, 46026
    • Teva Investigational Site 31292
• Ukraine
  • Chernivtsi, Ukraine, 58002
    • Teva Investigational Site 58327
  • Ivano-Frankivsk, Ukraine, 76008
    • Teva Investigational Site 58324
  • Lviv, Ukraine, 79000
    • Teva Investigational Site 58329
  • Lviv, Ukraine, 79010
    • Teva Investigational Site 58325
  • Lviv, Ukraine, 79010
    • Teva Investigational Site 58332
  • Ternopil, Ukraine, 46002
    • Teva Investigational Site 58328
  • Uzhhorod, Ukraine, 88000
    • Teva Investigational Site 58322
  • Uzhhorod, Ukraine, 88000
    • Teva Investigational Site 58323
  • Vinnytsia, Ukraine, 21018
    • Teva Investigational Site 58330
  • Vinnytsia, Ukraine, 21018
    • Teva Investigational Site 58331
• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Teva Investigational Site 34305
• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Teva Investigational Site 15568
  • California
    • San Diego, California, United States, 92103
      • Teva Investigational Site 15556
    • San Diego, California, United States, 92103
      • Teva Investigational Site 15747
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Teva Investigational Site 15357
    • Miami, Florida, United States, 33032
      • Teva Investigational Site 15563
    • Miami, Florida, United States, 33136
      • Teva Investigational Site 15365
    • Miami, Florida, United States, 33176
      • Teva Investigational Site 15748
    • Orlando, Florida, United States, 32803
      • Teva Investigational Site 15375
    • Pinellas Park, Florida, United States, 33781
      • Teva Investigational Site 15359
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Teva Investigational Site 15566
    • Gurnee, Illinois, United States, 60031
      • Teva Investigational Site 15567
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Teva Investigational Site 15574
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Teva Investigational Site 15362
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Teva Investigational Site 15367
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Teva Investigational Site 15368
    • Louisville, Kentucky, United States, 40218
      • Teva Investigational Site 15575
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Teva Investigational Site 15363
  • Missouri
    • Liberty, Missouri, United States, 64068
      • Teva Investigational Site 15358
    • St Louis, Missouri, United States, 63110
      • Teva Investigational Site 15373
  • Nevada
    • Las Vegas, Nevada, United States, 89128.
      • Teva Investigational Site 15369
  • New York
    • North Massapequa, New York, United States, 11758
      • Teva Investigational Site 15558
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Teva Investigational Site 15370
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • Teva Investigational Site 15750
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Teva Investigational Site 15557
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Teva Investigational Site 15573
  • Texas
    • Austin, Texas, United States, 78748
      • Teva Investigational Site 15360
    • Dallas, Texas, United States, 75246
      • Teva Investigational Site 15371
    • Garland, Texas, United States, 75044
      • Teva Investigational Site 15569
    • Harlingen, Texas, United States, 78550
      • Teva Investigational Site 15559
    • Katy, Texas, United States, 77494
      • Teva Investigational Site 15366
    • Lubbock, Texas, United States, 79424
      • Teva Investigational Site 15743
    • Pearland, Texas, United States, 77584
      • Teva Investigational Site 15372
    • San Antonio, Texas, United States, 78229
      • Teva Investigational Site 15374
    • Southlake, Texas, United States, 76092
      • Teva Investigational Site 15565
    • Tyler, Texas, United States, 75701
      • Teva Investigational Site 15361
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Teva Investigational Site 15364

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

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo UC; Matching Placebo	Drug: Placebo; Matching Placebo
Placebo Comparator: Placebo CD; Matching Placebo	Drug: Placebo; Matching Placebo
Experimental: TEV-48574, 450 mg (UC); Administered by subcutaneous infusion for participants with UC	Drug: TEV-48574; Subcutaneous infusion; Other Names: duvakitug
Experimental: TEV-48574, 900 mg (UC); Administered by subcutaneous infusion for participants with UC	Drug: TEV-48574; Subcutaneous infusion; Other Names: duvakitug
Experimental: TEV-48574, 1800 mg (UC); Administered by subcutaneous infusion for participants with UC. This arm was discontinued with Amend 03.	Drug: TEV-48574; Subcutaneous infusion; Other Names: duvakitug
Experimental: TEV-48574, 450 mg (CD); Administered by subcutaneous infusion for participants with CD	Drug: TEV-48574; Subcutaneous infusion; Other Names: duvakitug
Experimental: TEV-48574, 900 mg (CD); Administered by subcutaneous infusion for participants with CD	Drug: TEV-48574; Subcutaneous infusion; Other Names: duvakitug
Experimental: TEV-48574, 1800 mg (CD); Administered by subcutaneous infusion for participants with CD. This arm was discontinued with Amend 03.	Drug: TEV-48574; Subcutaneous infusion; Other Names: duvakitug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Moderate to Severe UC Who Showed Clinical Remission as Defined by the MMS	The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranging from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical remission was defined as MMS ≤2 points with Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and centrally read endoscopic score of 0 or 1, where a score of 1 did not include "friability".	Week 14
Number of Participants With Moderate to Severe CD Who Showed an Endoscopic Response as Defined by the SES-CD	The SES-CD assessed the degree of inflammation. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with larger scores indicating greater degree of inflammation. Endoscopic response at Week 14 in participants with moderate to severe CD was defined as a reduction in SES-CD of at least 50% from baseline.	Baseline to 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 the MMS	The MMS is a tool designed to measure disease activity for UC. It consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review. Each subscore was graded from 0 (normal) to 3 (severe). These individual subscores were summed up to give a total MMS ranged from 0 (normal or inactive disease) to 9 (severe disease), where higher scores indicated more severe disease activity. Clinical response was defined as a decrease from baseline in the MMS 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 ≤1.	Baseline to Week 14
Number of Participants With Moderate to Severe UC With Endoscopic Improvement as Defined by the Mayo Endoscopic Subscore (MES)	The endoscopic subscore evaluation for the MMS consisted of independent, blinded, central review of a high-resolution recorded video. The endoscopic subscore assessed disease activity from 0 (normal or inactive disease) to 3 (severe activity). Higher scores indicated more severe disease activity. Endoscopic improvement was defined as a MES of 0 or 1 at Week 14.	Week 14
Number of Participants With Moderate to Severe UC With Endoscopic Remission as Defined by the MES	The endoscopic subscore evaluation for the MMS consisted of independent, blinded, central review of a high-resolution recorded video. The endoscopic subscore assessed disease activity from 0 (normal or inactive disease) to 3 (severe activity). Higher scores indicated more severe disease activity. Endoscopic remission was defined as a MES of 0 at Week 14.	Week 14
Number of Participants With Moderate to Severe UC With a Clinical Response as Defined by 2-item Patient-reported Outcome (PRO2) Score	The PRO2-UC score was derived from 2 parameters from the MMS: stool frequency and rectal bleeding, recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Each parameter ranged from 0 (normal) to 3 (severe) with each subscore representing an average over the preceding 7 days. The total score was the summation of the subscores and therefore ranged from 0 (normal or inactive disease) to 6 (severe activity), where higher scores indicated more severe disease activity. Clinical response was defined as decrease from baseline of at least 50% in PRO2 (stool frequency and rectal bleeding) at Week 14.	Baseline to Week 14
Number of Participants With Moderate to Severe UC With a Clinical Remission as Defined by PRO2 Score	The PRO2-UC score was derived from 2 parameters from the MMS: stool frequency and rectal bleeding, recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Each parameter ranged from 0 (normal) to 3 (severe) with each subscore representing an average over the preceding 7 days. The total score was the summation of the subscores and therefore ranged from 0 (normal or inactive disease) to 6 (severe activity), where higher scores indicated more severe disease activity. Clinical remission was defined as score of stool frequency = 0 and rectal bleeding = 0 on the PRO2 scale at Week 14.	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)	The MM-SES-CD is an endoscopic scoring tool that considers each individual parameter's prognostic value for achieving endoscopic remission while on active therapy. The SES-CD assesses the following 4 components: presence of ulcers, percentage of ulcerated surfaces, affected surface, and presence of strictures. Each of these components was scored on a scale of 0 (none/unaffected) to 3 (worst). In the SES-CD, each of these 4 components was assessed in the 5 segments: the rectum, sigmoid and left colon, transverse colon, right colon, and ileum. The SES-CD was the sum of the individual scores of each of the components across the 5 segments. The range of SES-CD scores was 0 (none) - 12 (severe) for each segment, and 0 (none) - 60 (severe) for the overall SES-CD score, with higher scores indicating a greater degree of inflammation. Endoscopic response was defined as a decrease in MM-SES-CD of ≥50% from baseline at Week 14.	Baseline to Week 14
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by Crohn's Disease Activity Index (CDAI) Score	The CDAI score consisted of an adjusted composite sum of 8 parameters, including daily diary evaluation for severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight, and hematocrit. The subscores of abdominal pain (0 [no pain] to 3 [worst pain]), general well-being (0 [well] to 4 [terrible]), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score that ranged from 0 (none) to 600 (severe) with a higher score indicating a worse outcome. Clinical response was defined as a ≥100-point decrease in CDAI score from baseline.	Baseline to Weeks 4, 8, 12 and 14
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by CDAI Score	The CDAI score consisted of an adjusted composite sum of 8 parameters, including daily diary evaluation for severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight, and hematocrit. The subscores of abdominal pain (0 [no pain] to 3 [worst pain]), general well-being (0 [well] to 4 [terrible]), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score that ranged from 0 (none) to 600 (severe) with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI score <150 at Week 14.	Week 14
Number of Participants With Moderate to Severe CD With a Clinical Response as Defined by PRO2-CD Score	The PRO2-CD score was the sum of the daily stool frequency subscore (0 [normal] to 3 [severe]) and abdominal pain subscore (0 [no pain] to 3 [worst pain]) from the CDAI. Total PRO2-CD score ranged from 0 (normal) - 6 (severe), with higher scores indicating more severe disease. These were recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Clinical response was defined as a decrease from baseline of at least 50% in PRO2-CD (abdominal pain and stool frequency) at Week 14.	Baseline to Week 14
Number of Participants With Moderate to Severe CD With a Clinical Remission as Defined by PRO2-CD Score	The PRO2-CD score was the sum of the daily stool frequency subscore (0 [normal] to 3 [severe]) and abdominal pain subscore (0 [no pain] to 3 [worst pain]) from the CDAI. Total PRO2-CD score ranged from 0 (normal) - 6 (severe), with higher scores indicating more severe disease. These were recorded daily by the participant using a handheld electronic diary over each of the preceding 7 days. Clinical remission was defined as abdominal pain ≤1 and stool frequency ≤3 on the PRO2-CD scale at Week 14	Week 14
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)	An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were considered TEAEs if onset occurred on or after the first dose date. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.	Baseline (Day 1) up to Week 18
Number of Participants Who Stopped Taking the Investigational Medicinal Product (IMP) Due to AEs	An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.	Baseline (Day 1) up to Week 18
Number of Participants With Treatment-emergent Anti-Drug Antibodies (ADAs)	Treatment-emergent ADA positive: - the participant had a positive ADA sample (after first dose of study drug) but not at baseline (prior to first dose of study drug), or - the participant had a positive ADA sample at baseline (prior to first dose of study drug) and at the visit (after first dose of study drug), with at least a 4-fold increase in titer level.	Weeks 2, 4, 8, 14, and 18
Number of ADA Positive Participants With the Presence of Neutralizing ADA	Treatment-emergent ADA positive: - the participant had a positive ADA sample (after first dose of study drug) but not at baseline (prior to first dose of study drug), or - the participant had a positive ADA sample at baseline (prior to first dose of study drug) and at the visit (after first dose of study drug), with at least a 4-fold increase in titer level.	Weeks 2, 4, 8, 14, and 18

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): November 12, 2024

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): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: TV48574-IMM-20036; 2021-006881-19 (EudraCT Number); 2024-511089-36-00 (Registry Identifier: Clinical Trials Information System)

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 assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, 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 email USMedInfo@tevapharm.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