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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

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 more

Side effects data

From 2023 Phase 2 trial • 291 Patients • NCT04433585

16%

Injection site reaction

15%

Pyrexia

Fatigue

Arthralgia

Nasopharyngitis

Anaemia

Alanine aminotransferase increased

Injection site erythema

Injection site pain

Urinary tract infection

Injection site pruritus

Myalgia

Asthenia

Bronchitis

COVID-19

Gamma-glutamyltransferase increased

Erythema

Pruritus

Injection site rash

Pain

Headache

Dermatitis contact

Pityriasis rosea

Aspartate aminotransferase increased

Heavy menstrual bleeding

Back pain

Pharyngitis

Drug hypersensitivity

Nausea

Pain in extremity

Dyspepsia

Injection site swelling

Influenza

Rash

Urticaria

Vertigo

Post procedural complication

Bundle branch block right

Vomiting

Memory impairment

Application site reaction

Injection site erosion

Diarrhoea

Influenza like illness

Erythema of eyelid

Gastritis

Dental caries

Neck pain

Skin infection

Eosinophilia

Mouth ulceration

Sinusitis

Chills

Nasal obstruction

Hypotension

Injection site exfoliation

Oedema peripheral

Eczema

Nasal dryness

Post procedural oedema

Pharyngitis bacterial

Swelling face

Dysuria

Injection site hypersensitivity

Localised oedema

Dysaesthesia

Dry eye

Pollakiuria

Myopia

Groin pain

Ophthalmic migraine

Cough

Delusion

Feeling abnormal

Joint dislocation

Rash maculo-papular

Lymphadenitis

Dizziness

Furuncle

Systemic lupus erythematosus

Neutropenia

Depression

Haemorrhoids

Heart rate increased

Thermal burn

Chest pain

Rhinorrhoea

Sensation of foreign body

Arthritis

Seasonal allergy

Abdominal pain

Oesophageal motility disorder

Ligament sprain

Iron deficiency anaemia

Oropharyngeal pain

Fungal infection

Otitis externa

Upper respiratory tract infection

Pyelonephritis

COVID-19 pneumonia

Rhinitis

Oral candidiasis

Viral infection

Procedural pain

Hypertension

Urine protein/creatinine ratio increased

Urinary sediment

Limb injury

Vaccination complication

Hot flush

Soft tissue injury

Vision blurred

100%

80%

60%

40%

20%

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

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