Your session is about to expire
← Back to Search
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
Summary
This trial is testing a new medicine called LY3471851 to see if it is safe and effective for adults with active ulcerative colitis. The medicine aims to help by boosting immune cells that reduce inflammation in the colon.
Eligible Conditions
- Ulcerative Colitis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Who Achieved Clinical Remission at Week 12
Secondary study objectives
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 moreSide effects data
From 2023 Phase 2 trial • 291 Patients • NCT0443358516%
Injection site reaction
15%
Pyrexia
8%
Fatigue
7%
Arthralgia
7%
Nasopharyngitis
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Injection site erythema
5%
Injection site pain
5%
Urinary tract infection
4%
Injection site pruritus
4%
Asthenia
4%
Myalgia
4%
Bronchitis
4%
COVID-19
4%
Gamma-glutamyltransferase increased
4%
Erythema
4%
Pruritus
3%
Pain
3%
Headache
3%
Injection site rash
3%
Dermatitis contact
3%
Pityriasis rosea
3%
Aspartate aminotransferase increased
3%
Heavy menstrual bleeding
3%
Back pain
3%
Pharyngitis
3%
Drug hypersensitivity
3%
Nausea
3%
Pain in extremity
3%
Dyspepsia
3%
Injection site swelling
3%
Influenza
3%
Rash
3%
Urticaria
1%
Dental caries
1%
Erythema of eyelid
1%
Vertigo
1%
Post procedural complication
1%
Neck pain
1%
Eosinophilia
1%
Influenza like illness
1%
Bundle branch block right
1%
Skin infection
1%
Application site reaction
1%
Injection site erosion
1%
Localised oedema
1%
Diarrhoea
1%
Vomiting
1%
Cough
1%
Mouth ulceration
1%
Sinusitis
1%
Chills
1%
Injection site hypersensitivity
1%
Memory impairment
1%
Nasal obstruction
1%
Hypotension
1%
Injection site exfoliation
1%
Oedema peripheral
1%
Eczema
1%
Nasal dryness
1%
Post procedural oedema
1%
Pharyngitis bacterial
1%
Swelling face
1%
Dysuria
1%
Dysaesthesia
1%
Dry eye
1%
Pollakiuria
1%
Myopia
1%
Groin pain
1%
Ophthalmic migraine
1%
Feeling abnormal
1%
Joint dislocation
1%
Rash maculo-papular
1%
Lymphadenitis
1%
Dizziness
1%
Furuncle
1%
Systemic lupus erythematosus
1%
Haemorrhoids
1%
Heart rate increased
1%
Thermal burn
1%
Chest pain
1%
Rhinorrhoea
1%
Neutropenia
1%
Sensation of foreign body
1%
Arthritis
1%
Seasonal allergy
1%
Abdominal pain
1%
Oesophageal motility disorder
1%
Ligament sprain
1%
Iron deficiency anaemia
1%
Oropharyngeal pain
1%
Depression
1%
Delusion
1%
Fungal infection
1%
Gastritis
1%
Otitis externa
1%
Upper respiratory tract infection
1%
Pyelonephritis
1%
COVID-19 pneumonia
1%
Rhinitis
1%
Oral candidiasis
1%
Viral infection
1%
Procedural pain
1%
Hypertension
1%
Urine protein/creatinine ratio increased
1%
Urinary sediment
1%
Limb injury
1%
Vaccination complication
1%
Hot flush
1%
Soft tissue injury
1%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
LY3471851 High Dose
LY3471851 Mid Dose
LY3471851 Low Dose
Placebo
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
2,667 Previous Clinical Trials
3,228,396 Total Patients Enrolled
10 Trials studying Ulcerative Colitis
4,306 Patients Enrolled for Ulcerative Colitis
Nektar TherapeuticsLead Sponsor
58 Previous Clinical Trials
10,235 Total Patients Enrolled
Study DirectorStudy DirectorNektar Therapeutics
1,271 Previous Clinical Trials
503,843 Total Patients Enrolled
25 Trials studying Ulcerative Colitis
9,720 Patients Enrolled for Ulcerative Colitis
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger