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Crohn DiseasePhase 2NCT05668013

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

A Phase 2 study testing TEV-48574 Dose Regimen A and TEV-48574 Dose Regiment B in people with Crohn Disease and Colitis, Ulcerative, run by Teva Branded Pharmaceutical Products R&D LLC at 93 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn Disease, Colitis, Ulcerative
What is being tested?
TEV-48574 Dose Regimen A and TEV-48574 Dose Regiment B
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
247 participants
Where
93 sitesin 16 countries
Study dates
11 Jan 2023to 31 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

93 sites in 16 countries.

93 sites in 16 countries

Poland31 sites

  • Teva Investigational Site 53565

    Bydgoszcz, 85-794

  • Teva Investigational Site 53542

    Częstochowa, 42-202

  • Teva Investigational Site 53543

    Elblag, 82-300

  • Teva Investigational Site 53544

    Gdansk, 80-382

  • Teva Investigational Site 53546

    Katowice, 40-040

  • Teva Investigational Site 53547

    Kłodzko, 57-300

  • Teva Investigational Site 53560

    Krakow, 30-363

  • Teva Investigational Site 53548

    Krakow, 31-156

  • Teva Investigational Site 53512

    Krakow, 31-506

  • Teva Investigational Site 53511

    Łęczna, 21-010

  • Teva Investigational Site 53515

    Lodz, 90-752

  • Teva Investigational Site 53518

    Nowy Targ, 34-400

  • Teva Investigational Site 53549

    Poznan, 54-144

  • Teva Investigational Site 53563

    Poznan, 54-144

  • Teva Investigational Site 53516

    Poznan, 60-529

  • Teva Investigational Site 53566

    Poznan, 60-702

  • Teva Investigational Site 53550

    Sopot, 81-756

  • Teva Investigational Site 53551

    Staszów, 28-200

  • Teva Investigational Site 53508

    Szczecin, 71-434

  • Teva Investigational Site 53519

    Szczecin, 71-685

  • Teva Investigational Site 53553

    Torun, 87-100

  • Teva Investigational Site 53554

    Wadowice, 34-100

  • Teva Investigational Site 53557

    Warsaw, 00-189

  • Teva Investigational Site 53570

    Warsaw, 02-672

  • Teva Investigational Site 53556

    Warsaw, 02-786

  • Teva Investigational Site 53555

    Warsaw, 04-501

  • Teva Investigational Site 53510

    Wroclaw, 52-416

  • Teva Investigational Site 53567

    Wroclaw, 53-149

  • Teva Investigational Site 53562

    Wroclaw, 53-611

  • Teva Investigational Site 53520

    Wroclaw, 53-673

  • Teva Investigational Site 53509

    Zamość, 22-400

Other trials in Poland

United States18 sites

  • Teva Investigational Site 15750

    Beavercreek, Ohio, 45440

  • Teva Investigational Site 15567

    Gurnee, Illinois, 60031

  • Teva Investigational Site 15559

    Harlingen, Texas, 78550

  • Teva Investigational Site 15367

    Kansas City, Kansas, 66160

  • Teva Investigational Site 15366

    Katy, Texas, 77494

  • Teva Investigational Site 15357

    Kissimmee, Florida, 34741

  • Teva Investigational Site 15369

    Las Vegas, Nevada, 89128.

  • Teva Investigational Site 15358

    Liberty, Missouri, 64068

  • Teva Investigational Site 15575

    Louisville, Kentucky, 40218

  • Teva Investigational Site 15574

    New Albany, Indiana, 47150

  • Teva Investigational Site 15375

    Orlando, Florida, 32803

  • Teva Investigational Site 15359

    Pinellas Park, Florida, 33781

  • Teva Investigational Site 15364

    Salt Lake City, Utah, 84124

  • Teva Investigational Site 15374

    San Antonio, Texas, 78229

  • Teva Investigational Site 15556

    San Diego, California, 92103

  • Teva Investigational Site 15565

    Southlake, Texas, 76092

  • Teva Investigational Site 15373

    St Louis, Missouri, 63110

  • Teva Investigational Site 15361

    Tyler, Texas, 75701

Other trials in United States

Ukraine8 sites

  • Teva Investigational Site 58327

    Chernivtsi, 58002

  • Teva Investigational Site 58324

    Ivano-Frankivsk, 76008

  • Teva Investigational Site 58329

    Lviv, 79000

  • Teva Investigational Site 58325

    Lviv, 79010

  • Teva Investigational Site 58332

    Lviv, 79010

  • Teva Investigational Site 58322

    Uzhhorod, 88018

  • Teva Investigational Site 58330

    Vinnytsia, 21018

  • Teva Investigational Site 58331

    Vinnytsia, 21018

Other trials in Ukraine

Japan5 sites

  • Teva Investigational Site 84110

    Kashiwa, 277-0871

  • Teva Investigational Site 84117

    Minato, 108-8642

  • Teva Investigational Site 84114

    Sakura, 285-8741

  • Teva Investigational Site 84116

    Shinjuku, 169-0073

  • Teva Investigational Site 84111

    Toyama, 930-8550

Other trials in Japan

Slovakia5 sites

  • Teva Investigational Site 62074

    Bardejov, 085 01

  • Teva Investigational Site 62073

    Bratislava, 811 09

  • Teva Investigational Site 62071

    Košice, 040 13

  • Teva Investigational Site 62076

    Prešov, 080 01

  • Teva Investigational Site 62097

    Prešov, 080 01

Other trials in Slovakia

Germany4 sites

  • Teva Investigational Site 32793

    Kiel, 24105

  • Teva Investigational Site 32795

    Tübingen, 72076

  • Teva Investigational Site 32794

    Ulm, 89081

  • Teva Investigational Site 32874

    Wipperfürth, 51688

Other trials in Germany

Bulgaria3 sites

  • Teva Investigational Site 59243

    Gorna Oryahovitsa, 5100

  • Teva Investigational Site 59197

    Sofia, 1618

  • Teva Investigational Site 59196

    Sofia, 1784

Other trials in Bulgaria

Czechia3 sites

  • Teva Investigational Site 54221

    Brno, 615 00

  • Teva Investigational Site 54222

    Klatovy, 339 01

  • Teva Investigational Site 54220

    Slaný, 274 01

Other trials in Czechia

Hungary3 sites

  • Teva Investigational Site 51334

    Budapest, 1085

  • Teva Investigational Site 51335

    Budapest, H-1033

  • Teva Investigational Site 51338

    Vác, H-2600

Other trials in Hungary

Italy3 sites

  • Teva Investigational Site 30285

    Milan, 20132

  • Teva Investigational Site 30286

    Milan, 20157

  • Teva Investigational Site 30284

    Rozzano, 20089

Other trials in Italy

Spain3 sites

  • Teva Investigational Site 31293

    Huelva, 21005

  • Teva Investigational Site 31318

    Santiago de Compostela, 15702

  • Teva Investigational Site 31292

    Valencia, 46026

Other trials in Spain

Georgia2 sites

  • Teva Investigational Site 81052

    Tbilisi, 0119

  • Teva Investigational Site 81053

    Tbilisi, 0180

Other trials in Georgia

Israel2 sites

  • Teva Investigational Site 80179

    Afula, 1834111

  • Teva Investigational Site 80191

    Beersheba, 8410101

Other trials in Israel

Austria1 site

  • Teva Investigational Site 33056

    Vienna, 1090

Other trials in Austria

Norway1 site

  • Teva Investigational Site 41015

    Lorenskog, 1478

Other trials in Norway

United Kingdom1 site

  • Teva Investigational Site 34305

    London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: A Phase 2b, Randomized, Double-Blind Long-Term Extension Study to Evaluate Pharmacokinetics, Efficacy, Safety, and Tolerability of TEV-48574 in Adult Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease Who Completed the Treatment Phase of the Dose-Ranging Study (RELIEVE UCCD LTE)

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:

Read more
  • 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.

Being tested
TEV-48574 Dose Regimen A, TEV-48574 Dose Regiment B
Medical subject headings
Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEV-48574 Dose Regimen ADrug

    Also called duvakitug

    Subcutaneous (sc) administration using a commercial sc infusion system

  • TEV-48574 Dose Regiment BDrug

    Also called duvakitug

    Subcutaneous (sc) administration using a commercial sc infusion system

Study groups in NCT05668013
Study groupRoleWhat they receive
TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)ExperimentalAdministered by subcutaneous infusion for participants with UC
Receives: Drug: TEV-48574 Dose Regimen A
TEV-48574 Dose Regimen A for Crohn's Disease (CD)ExperimentalAdministered by subcutaneous infusion for participants with CD
Receives: Drug: TEV-48574 Dose Regimen A
TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)ExperimentalAdministered by subcutaneous infusion for participants with UC
Receives: Drug: TEV-48574 Dose Regiment B
TEV-48574 Dose Regimen B for Crohn's Disease (CD)ExperimentalAdministered by subcutaneous infusion for participants with CD
Receives: Drug: TEV-48574 Dose Regiment B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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"

    Measured: Week 44

  2. 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

    Measured: Week 44

Secondary outcomes (14)

  1. 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

    Measured: Week 44

  2. 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

    Measured: Week 44

  3. 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

    Measured: Week 44

  4. 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

    Measured: Week 44

  5. 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

    Measured: Week 44

  6. 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

    Measured: Week 44

  7. 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

    Measured: Week 44

  8. 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

    Measured: Week 44

  9. Number of participants who experience adverse events in the double-blind period

    Adverse events can include any of the following 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.

    Measured: Up to Week 48

  10. Number of participants who experience adverse events in the open-label (OL) period

    Adverse events can include any of the following 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.

    Measured: Up to 5 years after start of OL period

  11. Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the double-blind period

    Measured: Up to Week 48

  12. Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the open-label (OL) period

    Measured: Up to 5 years after start of OL period

  13. Number of participants with treatment emergent Anti-Drug Antibodies (ADA)

    Measured: Weeks 0, 4, 8, 16, 28, 44, and 48

  14. Number of ADA positive participants with the presence of neutralizing ADA

    Measured: Weeks 0, 4, 8, 16, 28, 44, and 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2022
  2. Study start11 Jan 2023
  3. Primary completion5 Jan 2026
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668013
Sponsor's protocol ID
TV48574-IMM-20038
Other IDs
2022-002593-89, 2024-515027-11-00
Status last verified
Oct 2026
First submitted
12 Dec 2022
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Solitano V, Jairath V, Ungaro F, Peyrin-Biroulet L, Danese S. TL1A inhibition for inflammatory bowel disease treatment: From inflammation to fibrosis. Med. 2024 May 10;5(5):386-400. doi: 10.1016/j.medj.2024.03.010. Epub 2024 Apr 3.

    PubMed 38574740

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TEV-48574 Dose Regimen A and TEV-48574 Dose Regiment B in people with Crohn Disease and Colitis, Ulcerative, run by Teva Branded Pharmaceutical Products R&D LLC at 93 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Poland, United States, Ukraine, Japan, Slovakia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score (time frame: Week 44). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05668013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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