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

Crohn Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668013
• Other study ID #: TV48574-IMM-20038
• Secondary ID: 2022-002593-89
• Status: Recruiting
• Phase: Phase 2
• Start date: January 11, 2023
• Est. completion date: August 2, 2031

Study information

• Verified date: June 2024
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: Teva U.S. Medical Information
• Phone: 1-888-483-8279
• Email: USMedInfo[@]tevapharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: August 2, 2031
• Est. primary completion date: July 5, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer

Intervention

Drug:
• TEV-48574 Dose Regimen A
Subcutaneous (sc) administration using a commercial sc infusion system
• TEV-48574 Dose Regiment B
Subcutaneous (sc) administration using a commercial sc infusion system

Locations

Country	Name	City	State
Austria	Teva Investigational Site 33055	Innsbruck
Belgium	Teva Investigational Site 37134	Edegem
Belgium	Teva Investigational Site 37133	Liege
Bulgaria	Teva Investigational Site 59198	Pleven
Bulgaria	Teva Investigational Site 59196	Sofia
Bulgaria	Teva Investigational Site 59197	Sofia
Bulgaria	Teva Investigational Site 59199	Sofia
Czechia	Teva Investigational Site 54221	Brno
Czechia	Teva Investigational Site 54220	Slany
France	Teva Investigational Site 35280	Caen cedex
France	Teva Investigational Site 35277	Nice Cedex 3
France	Teva Investigational Site 35279	Saint Etienne
Hungary	Teva Investigational Site 51334	Budapest
Hungary	Teva Investigational Site 51335	Budapest
Hungary	Teva Investigational Site 51336	Gyongyos
Hungary	Teva Investigational Site 51333	Szekesfehervar
Hungary	Teva Investigational Site 51338	Vac
Italy	Teva Investigational Site 30284	Rozzano
Japan	Teva Investigational Site 84112	Fukuoka-shi
Japan	Teva Investigational Site 84110	Kashiwa-shi
Japan	Teva Investigational Site 84117	Minato-ku
Japan	Teva Investigational Site 84118	Nagoya-shi
Japan	Teva Investigational Site 84113	Osaka-shi
Japan	Teva Investigational Site 84114	Sakura-shi
Japan	Teva Investigational Site 84116	Shinjuku-ku
Japan	Teva Investigational Site 84111	Toyama-shi
Poland	Teva Investigational Site 53512	Krakow
Poland	Teva Investigational Site 53511	Leczna
Poland	Teva Investigational Site 53514	Lodz
Poland	Teva Investigational Site 53515	Lodz
Poland	Teva Investigational Site 53518	Nowy Targ
Poland	Teva Investigational Site 53516	Poznan
Poland	Teva Investigational Site 53517	Poznan
Poland	Teva Investigational Site 53513	Rzeszow
Poland	Teva Investigational Site 53508	Szczecin
Poland	Teva Investigational Site 53519	Szczecin
Poland	Teva Investigational Site 53510	Wroclaw
Poland	Teva Investigational Site 53509	Zamosc
Slovakia	Teva Investigational Site 62074	Bardejov
Slovakia	Teva Investigational Site 62073	Bratislava
Slovakia	Teva Investigational Site 62071	Kosice
Slovakia	Teva Investigational Site 62076	Presov
Slovakia	Teva Investigational Site 62072	Sahy
Spain	Teva Investigational Site 31302	Cordoba
Spain	Teva Investigational Site 31293	Huelva
Spain	Teva Investigational Site 31318	Santiago de Compostela
Spain	Teva Investigational Site 31291	Sevilla
Spain	Teva Investigational Site 31292	Valencia
United States	Teva Investigational Site 15370	Chapel Hill	North Carolina
United States	Teva Investigational Site 15363	Columbia	Maryland
United States	Teva Investigational Site 15559	Harlingen	Texas
United States	Teva Investigational Site 15367	Kansas City	Kansas
United States	Teva Investigational Site 15366	Katy	Texas
United States	Teva Investigational Site 15357	Kissimmee	Florida
United States	Teva Investigational Site 15369	Las Vegas	Nevada
United States	Teva Investigational Site 15358	Leawood	Kansas
United States	Teva Investigational Site 15365	Miami	Florida
United States	Teva Investigational Site 15558	North Massapequa	New York
United States	Teva Investigational Site 15375	Orlando	Florida
United States	Teva Investigational Site 15372	Pearland	Texas
United States	Teva Investigational Site 15364	Salt Lake City	Utah
United States	Teva Investigational Site 15374	San Antonio	Texas
United States	Teva Investigational Site 15556	San Diego	California
United States	Teva Investigational Site 15359	Tampa	Florida
United States	Teva Investigational Site 15361	Tyler	Texas
United States	Teva Investigational Site 15560	Vancouver	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.	Sanofi

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bulgaria,  Czechia,  France,  Hungary,  Italy,  Japan,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"	Week 44
Primary	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	Week 44
Secondary	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	Week 44
Secondary	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	Week 44
Secondary	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	Week 44
Secondary	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	Week 44
Secondary	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	Week 44
Secondary	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	Week 44
Secondary	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	Week 44
Secondary	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	Week 44
Secondary	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.	Up to Week 48
Secondary	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.	Up to 5 years after start of OL period
Secondary	Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the double-blind period		Up to Week 48
Secondary	Number of participants who stopped taking the investigational medicinal product (IMP) due to adverse events in the open-label (OL) period		Up to 5 years after start of OL period
Secondary	Number of participants with treatment emergent Anti-Drug Antibodies (ADA)		Weeks 0, 4, 8, 16, 28, 44, and 48
Secondary	Number of ADA positive participants with the presence of neutralizing ADA		Weeks 0, 4, 8, 16, 28, 44, and 48