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

Browse trials for

• Crohn Disease 1,880
• Colitis, Ulcerative 1,492

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's enrollment of 247 is above the median of 66 across 1,188 interventional studies indexed under Crohn Disease.

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLC is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Study arms

• Experimental
  TEV-48574 Dose Regimen A for Ulcerative Colitis (UC)

  Administered by subcutaneous infusion for participants with UC

  Drug: TEV-48574 Dose Regimen A

• 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

• Experimental
  TEV-48574 Dose Regimen B for Ulcerative Colitis (UC)

  Administered by subcutaneous infusion for participants with UC

  Drug: TEV-48574 Dose Regiment B

• 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

Interventions

• DrugTEV-48574 Dose Regimen A

  Subcutaneous (sc) administration using a commercial sc infusion system

  Also known as: duvakitug

• DrugTEV-48574 Dose Regiment B

  Subcutaneous (sc) administration using a commercial sc infusion system

  Also known as: duvakitug

Primary outcomes

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"

   Time frame: 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

   Time frame: Week 44

Secondary outcomes

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

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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

   Time frame: 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.

   Time frame: 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.

    Time frame: 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

    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

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 ↗

Individual participant data

Plan to share: 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.