Terminated/Withdrawn
Sponsor ID
20210210

Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsor ID
20210210
Clinicaltrials.gov ID
NCT05672199
EUCTIS ID
N/A
EudraCT ID
2022-001686-12

Study Details

The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).

Additional Study Details

Phase
Phase 2
Product
Efavaleukin Alfa
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
25
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: Day 1 to Week 110

Secondary Outcome Measures

Number of Participants with Clinical Response at Week 52

Timeframe: Week 52

Number of Participants with Clinical Response at Week 104

Timeframe: Week 104

Number of Participants with Clinical Remission at Week 52

Timeframe: Week 52

Number of Participants with Clinical Remission at Week 104

Timeframe: Week 104

Number of Participants with Durable Clinical Remission at Week 52

Timeframe: Week 52

Number of Participants with Durable Clinical Remission at Week 104

Timeframe: Week 104

Number of Participants with Endoscopic Remission at Week 52

Timeframe: Week 52

Number of Participants with Endoscopic Remission at Week 104

Timeframe: Week 104

Number of Participants with Histologic Remission at Week 52

Timeframe: Week 52

Number of Participants with Histologic Remission at Week 104

Timeframe: Week 104

Number of Participants with Corticosteroid-free Remission

Timeframe: Week 52

Number of Participants with Corticosteroid-free Remission

Timeframe: Week 104

Number of Participants with Combined Endoscopic and Histologic Remission at Week 52

Timeframe: Week 52

Number of Participants with Combined Endoscopic and Histologic Remission at Week 104

Timeframe: Week 104

Number of Participants with Symptomatic Remission at Week 52

Timeframe: Week 52

Number of Participants with Symptomatic Remission at Week 104

Timeframe: Week 104

Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 52

Timeframe: Baseline of Study 20170104 to Week 52 of Long Term Extension Study (up to approximately 104 weeks)

Change from Baseline of Study 20170104 in Histological Score (Geboes) at Week 104

Timeframe: Baseline of Study 20170104 to Week 104 of Long Term Extension Study (up to approximately 156 weeks)

Study Documents

Plain Language Summary of Results
Available Language(s): English, German, Danish, Spanish (Mexico), Spanish (Argentina), Polish, Bulgarian, Korean, Romanian, Japanese, Turkish, Hungarian, French

Locations

Location
Status
Contact Us
Location
Intesto BE
Bern, Switzerland, 3012
Status
Terminated
Location
University of Kansas Medical Center
Kansas City, KS, United States, 66160
Status
Recruiting
Location
Santa Maria Gastroenterology Medical Group
Santa Maria, CA, United States, 93458
Status
Recruiting
Location
Spitalul Clinic Colentina
Bucuresti, Romania, 020125
Status
Recruiting
Location
Cer Instituto Medico
Quilmes, Buenos Aires, Argentina, B1878DVB
Status
Recruiting
Location
Nagasaki University Hospital
Nagasaki-shi, Nagasaki, Japan, 852-8501
Status
Recruiting
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