Efavaleukin alfa for Ulcerative Colitis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Ulcerative ColitisEfavaleukin alfa - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at whether or not a new drug, efavaleukin alfa, can help people with UC achieve clinical remission. Participants will be randomly assigned to receive either the drug or a placebo, and the effects will be monitored over the course of 12 weeks. There is also the option to enter an exploratory long-term treatment period for up to 52 weeks total.

Eligible Conditions
  • Ulcerative Colitis

Video Summary

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 58 weeks

Baseline to Week 12
Number of Participants with a Clinically Significant Change from Baseline in Histological Score at Week 12 as Measured by Geboes Score
Up to 58 weeks
Therapeutic procedure
Week 12
Number of Participants with Clinical Remission at Week 12
Number of Participants with Clinical Response at Week 12
Number of Participants with Combined Endoscopic Remission and Histologic Remission of the Colon Tissue at Week 12
Number of Participants with Endoscopic Remission at Week 12
Number of Participants with Symptomatic Remission at Week 12

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

6 Treatment Groups

Arm A: Efavaleukin alfa
1 of 6
Arm B: Efavaleukin alfa
1 of 6
Arm C: Efavaleukin alfa
1 of 6
Efavaleukin alfa
1 of 6
Arm D: Placebo
1 of 6
Placebo
1 of 6

Experimental Treatment

Non-Treatment Group

320 Total Participants · 6 Treatment Groups

Primary Treatment: Efavaleukin alfa · Has Placebo Group · Phase 2

Arm A: Efavaleukin alfa
Drug
Experimental Group · 1 Intervention: Efavaleukin alfa · Intervention Types: Drug
Arm B: Efavaleukin alfa
Drug
Experimental Group · 1 Intervention: Efavaleukin alfa · Intervention Types: Drug
Arm C: Efavaleukin alfa
Drug
Experimental Group · 1 Intervention: Efavaleukin alfa · Intervention Types: Drug
Efavaleukin alfa
Drug
Experimental Group · 1 Intervention: Efavaleukin alfa · Intervention Types: Drug
Arm D: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Efavaleukin alfa
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 58 weeks

Who is running the clinical trial?

AmgenLead Sponsor
1,296 Previous Clinical Trials
1,328,264 Total Patients Enrolled
6 Trials studying Ulcerative Colitis
1,844 Patients Enrolled for Ulcerative Colitis
MDStudy DirectorAmgen
838 Previous Clinical Trials
897,398 Total Patients Enrolled
5 Trials studying Ulcerative Colitis
844 Patients Enrolled for Ulcerative Colitis

Eligibility Criteria

Age 18 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have provided informed consent prior to study participation.

Who else is applying?

What state do they live in?
Georgia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Atlanta Gastroenterology Associates100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%