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NCT Number: NCT05668013

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Teva Investigational Site 33056, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEV-48574 Dose Regimen A

Drug

Subcutaneous (sc) administration using a commercial sc infusion system

Other names: duvakitug

TEV-48574 Dose Regiment B

Drug

Subcutaneous (sc) administration using a commercial sc infusion system

Other names: duvakitug

Primary outcomes

  1. Number of participants with moderate to severe ulcerative colitis (UC) who show clinical remission as defined by the Mayo score

    Time frame: Week 44

    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"

  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

    Time frame: Week 44

    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

Secondary outcomes

  1. Number of participants with moderate to severe UC with a clinical response as defined by Mayo score

    Time frame: Week 44

    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

  2. Number of participants with moderate to severe UC with Endoscopic improvement as defined by Mayo score

    Time frame: Week 44

    Endoscopic improvement defined as a Mayo endoscopic subscore of 0 or 1

  3. Number of participants with moderate to severe UC in Endoscopic remission as defined by Mayo score

    Time frame: Week 44

    Endoscopic remission defined as a Mayo endoscopic subscore of 0

  4. Number of participants with moderate to severe UC with Corticosteroid-free clinical remission based on the modified Mayo score

    Time frame: Week 44

    Defined by clinical remission and corticosteroid-free for ≥12 weeks preceding week 44

  5. Number of participants with moderate to severe CD with a clinical response based on Crohn's Disease Activity Index

    Time frame: Week 44

    Clinical response defined as a ≥100-point decrease from DRF baseline Crohn's Disease Activity Index (CDAI) score

  6. Number of participants with moderate to severe CD in clinical remission as defined by CDAI score

    Time frame: Week 44

    Clinical remission defined as a CDAI score less than 150

  7. Number of participants with moderate to severe CD with Corticosteroid-free endoscopic response based on SES-CD

    Time frame: Week 44

    Defined by endoscopic response and corticosteroid-free for ≥12 weeks preceding week 44

  8. Number of participants with moderate to severe CD with Corticosteroid-free clinical remission based on CDAI

    Time frame: Week 44

    Defined by a CDAI score of <150 points and corticosteroid-free for ≥12 weeks preceding week 44

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

    Time frame: Up to Week 48

    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.

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

    Time frame: Up to 5 years after start of 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.

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

    Time frame: 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

    Time frame: Up to 5 years after start of OL period

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

    Time frame: Weeks 0, 4, 8, 16, 28, 44, and 48

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

    Time frame: Weeks 0, 4, 8, 16, 28, 44, and 48

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLC

Industry

Collaborators

  • Sanofi

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Dec 29, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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