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

Last updated: February 27, 2025
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

TEV-48574 Dose Regimen A

TEV-48574 Dose Regiment B

Clinical Study ID

NCT05668013
TV48574-IMM-20038
2024-515027-11-00
2022-002593-89
  • Ages 18-75
  • All Genders

Study Summary

The primary objective of the study is to evaluate the efficacy 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 for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Maintenance Period- Participants who achieved clinical response and/or clinicalremission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in there-induction period of this study.

  • Re-induction- Participants who did not achieve clinical response and/or clinicalremission at week 14 of the TV48574-IMM-20036 DRF study

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

Exclusion

Exclusion Criteria:

  • Participants who discontinued the TV48574-IMM-20036 study before scheduled week 14visit (any reason including lack of efficacy, safety, or personal reasons)

  • Participant has any concomitant conditions or treatments that could interfere withstudy conduct, influence the interpretation of study observations/results, or putthe participant at increased risk during the study as judged by the investigatorand/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 orto lactate during the study or for at least 50 days after administration of the lastdose of IMP in case of early termination. Any woman becoming pregnant during thestudy will be withdrawn from the study.

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

Study Design

Total Participants: 218
Treatment Group(s): 2
Primary Treatment: TEV-48574 Dose Regimen A
Phase: 2
Study Start date:
January 11, 2023
Estimated Completion Date:
March 08, 2031

Connect with a study center

  • Teva Investigational Site 33055

    Innsbruck, 6020
    Austria

    Site Not Available

  • Teva Investigational Site 33056

    Vienna, 1090
    Austria

    Site Not Available

  • Teva Investigational Site 37134

    Edegem, 2650
    Belgium

    Site Not Available

  • Teva Investigational Site 37133

    Liege, 4000
    Belgium

    Site Not Available

  • Teva Investigational Site 59243

    Gorna Oryahovitsa, 5100
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59198

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59196

    Sofia, 1784
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59197

    Sofia, 1618
    Bulgaria

    Site Not Available

  • Teva Investigational Site 59199

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Teva Investigational Site 54221

    Brno, 615 00
    Czechia

    Site Not Available

  • Teva Investigational Site 54222

    Klatovy, 339 01
    Czechia

    Site Not Available

  • Teva Investigational Site 54220

    Slany, 274 01
    Czechia

    Site Not Available

  • Teva Investigational Site 35280

    Caen cedex, 14033
    France

    Site Not Available

  • Teva Investigational Site 35277

    Nice Cedex 3, 06200
    France

    Site Not Available

  • Teva Investigational Site 35279

    Saint Etienne, 42055
    France

    Site Not Available

  • Teva Investigational Site 81052

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Teva Investigational Site 81053

    Tbilisi, 0101
    Georgia

    Site Not Available

  • Teva Investigational Site 32793

    Kiel, 24105
    Germany

    Site Not Available

  • Teva Investigational Site 32795

    Tuebingen, 72076
    Germany

    Site Not Available

  • Teva Investigational Site 32794

    Ulm, 89081
    Germany

    Site Not Available

  • Teva Investigational Site 32874

    Wipperfuerth, 51688
    Germany

    Site Not Available

  • Teva Investigational Site 51334

    Budapest, 1085
    Hungary

    Site Not Available

  • Teva Investigational Site 51335

    Budapest, H-1033
    Hungary

    Site Not Available

  • Teva Investigational Site 51336

    Gyongyos, 3200
    Hungary

    Site Not Available

  • Teva Investigational Site 51333

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Teva Investigational Site 51338

    Vac, H-2600
    Hungary

    Site Not Available

  • Teva Investigational Site 80179

    Afula, 1834111
    Israel

    Site Not Available

  • Teva Investigational Site 80191

    Beer-Sheva, 8410101
    Israel

    Site Not Available

  • Teva Investigational Site 30285

    Milan, 20132
    Italy

    Site Not Available

  • Teva Investigational Site 30286

    Milan, 20157
    Italy

    Site Not Available

  • Teva Investigational Site 30284

    Rozzano, 20089
    Italy

    Site Not Available

  • Teva Investigational Site 84114

    Chiba, 285-8741
    Japan

    Site Not Available

  • Teva Investigational Site 84112

    Fukuoka-shi, 814-0180
    Japan

    Site Not Available

  • Teva Investigational Site 84110

    Kashiwa-shi, 277-0871
    Japan

    Site Not Available

  • Teva Investigational Site 84117

    Minato-ku, 108-8642
    Japan

    Site Not Available

  • Teva Investigational Site 84118

    Nagoya-shi, 457-8511
    Japan

    Site Not Available

  • Teva Investigational Site 84113

    Osaka-shi, 530-0011
    Japan

    Site Not Available

  • Teva Investigational Site 84114

    Sakura-shi, 285-8741
    Japan

    Site Not Available

  • Teva Investigational Site 84116

    Shinjuku-ku, 169-0073
    Japan

    Site Not Available

  • Teva Investigational Site 84116

    Tokyo, 169-0073
    Japan

    Site Not Available

  • Teva Investigational Site 84117

    Tokyo, 108-8642
    Japan

    Site Not Available

  • Teva Investigational Site 84111

    Toyama, 930-8550
    Japan

    Site Not Available

  • Teva Investigational Site 84111

    Toyama-shi, 930-8550
    Japan

    Site Not Available

  • Teva Investigational Site 41015

    Lorenskog, 1478
    Norway

    Site Not Available

  • Teva Investigational Site 53565

    Bydgoszcz, 85-794
    Poland

    Site Not Available

  • Teva Investigational Site 53542

    Czestochowa, 42-202
    Poland

    Site Not Available

  • Teva Investigational Site 53543

    Elblag, 82-300
    Poland

    Site Not Available

  • Teva Investigational Site 53544

    Gdansk, 80-382
    Poland

    Site Not Available

  • Teva Investigational Site 53546

    Katowice, 40-040
    Poland

    Site Not Available

  • Teva Investigational Site 53547

    Klodzko, 57-300
    Poland

    Site Not Available

  • Teva Investigational Site 53512

    Krakow, 31-506
    Poland

    Site Not Available

  • Teva Investigational Site 53548

    Krakow, 31-156
    Poland

    Site Not Available

  • Teva Investigational Site 53560

    Krakow, 30-363
    Poland

    Site Not Available

  • Teva Investigational Site 53511

    Leczna, 21-010
    Poland

    Site Not Available

  • Teva Investigational Site 53514

    Lodz, 91-495
    Poland

    Site Not Available

  • Teva Investigational Site 53515

    Lodz, 90-752
    Poland

    Site Not Available

  • Teva Investigational Site 53518

    Nowy Targ, 34-400
    Poland

    Site Not Available

  • Teva Investigational Site 53516

    Poznan, 60-529
    Poland

    Site Not Available

  • Teva Investigational Site 53517

    Poznan, 61-293
    Poland

    Site Not Available

  • Teva Investigational Site 53566

    Poznan, 60-702
    Poland

    Site Not Available

  • Teva Investigational Site 53513

    Rzeszow, 35-326
    Poland

    Site Not Available

  • Teva Investigational Site 53550

    Sopot, 81-756
    Poland

    Site Not Available

  • Teva Investigational Site 53551

    Staszow, 28-200
    Poland

    Site Not Available

  • Teva Investigational Site 53508

    Szczecin, 71-434
    Poland

    Site Not Available

  • Teva Investigational Site 53519

    Szczecin, 71-685
    Poland

    Site Not Available

  • Teva Investigational Site 53553

    Torun, 87-100
    Poland

    Site Not Available

  • Teva Investigational Site 53554

    Wadowice, 34-100
    Poland

    Site Not Available

  • Teva Investigational Site 53555

    Warsaw, 04-501
    Poland

    Site Not Available

  • Teva Investigational Site 53556

    Warsaw, 02-786
    Poland

    Site Not Available

  • Teva Investigational Site 53557

    Warsaw, 00-189
    Poland

    Site Not Available

  • Teva Investigational Site 53570

    Warsaw, 02-672
    Poland

    Site Not Available

  • Teva Investigational Site 53510

    Wroclaw, 52-416
    Poland

    Site Not Available

  • Teva Investigational Site 53520

    Wroclaw, 53-673
    Poland

    Site Not Available

  • Teva Investigational Site 53549

    Wroclaw, 54-144
    Poland

    Site Not Available

  • Teva Investigational Site 53562

    Wroclaw, 53-611
    Poland

    Site Not Available

  • Teva Investigational Site 53563

    Wroclaw, 54-144
    Poland

    Site Not Available

  • Teva Investigational Site 53567

    Wroclaw, 53-149
    Poland

    Site Not Available

  • Teva Investigational Site 53509

    Zamosc, 22-400
    Poland

    Site Not Available

  • Teva Investigational Site 62074

    Bardejov, 085 01
    Slovakia

    Site Not Available

  • Teva Investigational Site 62073

    Bratislava, 811 09
    Slovakia

    Site Not Available

  • Teva Investigational Site 62071

    Kosice, 040 13
    Slovakia

    Site Not Available

  • Teva Investigational Site 62076

    Presov, 080 01
    Slovakia

    Site Not Available

  • Teva Investigational Site 62097

    Presov, 080 01
    Slovakia

    Site Not Available

  • Teva Investigational Site 62072

    Sahy, 93601
    Slovakia

    Site Not Available

  • Teva Investigational Site 31302

    Cordoba, 14004
    Spain

    Site Not Available

  • Teva Investigational Site 31293

    Huelva, 21005
    Spain

    Site Not Available

  • Teva Investigational Site 31318

    Santiago de Compostela, 15702
    Spain

    Site Not Available

  • Teva Investigational Site 31291

    Sevilla, 41017
    Spain

    Site Not Available

  • Teva Investigational Site 31292

    Valencia, 46026
    Spain

    Site Not Available

  • Teva Investigational Site 58327

    Chernivtsi, 58002
    Ukraine

    Site Not Available

  • Teva Investigational Site 58324

    Ivano-Frankivsk, 76008
    Ukraine

    Site Not Available

  • Teva Investigational Site 58325

    Lviv, 79010
    Ukraine

    Site Not Available

  • Teva Investigational Site 58329

    Lviv, 79000
    Ukraine

    Site Not Available

  • Teva Investigational Site 58332

    Lviv, 79010
    Ukraine

    Site Not Available

  • Teva Investigational Site 58322

    Uzhhorod, 88000
    Ukraine

    Site Not Available

  • Teva Investigational Site 58330

    Vinnytsia, 21018
    Ukraine

    Site Not Available

  • Teva Investigational Site 58331

    Vinnytsia, 21018
    Ukraine

    Site Not Available

  • Teva Investigational Site 34305

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Teva Investigational Site 15556

    San Diego, California 92103
    United States

    Site Not Available

  • Teva Investigational Site 15357

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Teva Investigational Site 15365

    Miami, Florida 33136
    United States

    Site Not Available

  • Teva Investigational Site 15375

    Orlando, Florida 32803
    United States

    Site Not Available

  • Teva Investigational Site 15359

    Pinellas Park, Florida 33781
    United States

    Site Not Available

  • Teva Investigational Site 15359

    Tampa, Florida 33626
    United States

    Site Not Available

  • Teva Investigational Site 15567

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Teva Investigational Site 15574

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Teva Investigational Site 15367

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Teva Investigational Site 15358

    Leawood, Kansas 66214
    United States

    Site Not Available

  • Teva Investigational Site 15575

    Louisville, Kentucky 40218
    United States

    Site Not Available

  • Teva Investigational Site 15363

    Columbia, Maryland 21045
    United States

    Site Not Available

  • Teva Investigational Site 15358

    Liberty, Missouri 64068
    United States

    Site Not Available

  • Teva Investigational Site 15373

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Teva Investigational Site 15369

    Las Vegas, Nevada 89128.
    United States

    Site Not Available

  • Teva Investigational Site 15558

    North Massapequa, New York 11758
    United States

    Site Not Available

  • Teva Investigational Site 15370

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Teva Investigational Site 15750

    Beavercreek, Ohio 45440
    United States

    Site Not Available

  • Teva Investigational Site 15750

    Dayton, Ohio 45415
    United States

    Site Not Available

  • Teva Investigational Site 15559

    Harlingen, Texas 78550
    United States

    Site Not Available

  • Teva Investigational Site 15366

    Katy, Texas 77494
    United States

    Site Not Available

  • Teva Investigational Site 15372

    Pearland, Texas 77584
    United States

    Site Not Available

  • Teva Investigational Site 15374

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Teva Investigational Site 15565

    Southlake, Texas 76092
    United States

    Site Not Available

  • Teva Investigational Site 15361

    Tyler, Texas 75701
    United States

    Site Not Available

  • Teva Investigational Site 15364

    Salt Lake City, Utah 84124
    United States

    Site Not Available

  • Teva Investigational Site 15560

    Vancouver, Washington 98664
    United States

    Site Not Available

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