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Monoclonal Antibodies

LY3471851 for Ulcerative Colitis (INSTRUCT-UC Trial)

Phase 2
Waitlist Available
Research Sponsored by Nektar Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

INSTRUCT-UC Trial Summary

This study is evaluating whether a drug may help treat ulcerative colitis.

Eligible Conditions
  • Ulcerative Colitis

INSTRUCT-UC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Who Achieved Clinical Remission at Week 12
Secondary outcome measures
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) - Total Score
Percentage of Participants Who Achieved Clinical Response at Week 12
Percentage of Participants Who Achieved Endoscopic Remission at Week 12
+6 more

INSTRUCT-UC Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low dose LY3471851Experimental Treatment1 Intervention
Participants received a subcutaneous injection of low dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Group II: High dose LY3471851Experimental Treatment1 Intervention
Participants received a subcutaneous injection of high dose LY3471851 every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Group III: PlaceboPlacebo Group2 Interventions
Participants received a subcutaneous injection of placebo every 2 weeks from weeks 0 to 12. Week 12 responders entered the maintenance period and continued with the same treatment. Week 12 non-responders entered the extension period where they received subcutaneous injection of high dose LY3471851 every 2 weeks up to week 50. At week 26, extension period non-responders were discontinued from treatment. Post-treatment, participants entered follow-up period and were observed for 6 weeks for safety.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3471851
2021
Completed Phase 2
~670

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,479 Total Patients Enrolled
9 Trials studying Ulcerative Colitis
4,166 Patients Enrolled for Ulcerative Colitis
Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
10,261 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,209 Previous Clinical Trials
489,629 Total Patients Enrolled
24 Trials studying Ulcerative Colitis
9,807 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)
2021. "A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677179.
~20 spots leftby Apr 2025
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