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Monoclonal Antibodies

Citrate-Free Mirikizumab for Healthy Participants

Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Have a current infection with hepatitis C virus.
Have a current infection with hepatitis B virus.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 71 days postdose
Awards & highlights

Summary

This trial aims to compare how the body absorbs and eliminates mirikizumab when given through an autoinjector under the skin, as opposed to a mirikizumab solution. Participants will

Who is the study for?
This trial is for healthy individuals who can undergo screening within 35 days before joining. The study lasts about 15 weeks and involves comparing two forms of a drug called Mirikizumab administered with an autoinjector.
What is being tested?
The trial aims to compare the bioequivalence of citrate-free Mirikizumab (test) with the standard Mirikizumab solution (reference). Both are given via an autoinjector to see how they're absorbed and processed by the body.
What are the potential side effects?
Since this study is in healthy participants, specific side effects aren't listed, but common ones may include pain at injection site, redness, swelling, and potential allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently infected with hepatitis C.
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I am currently infected with hepatitis B.
Select...
I have signs of active or latent TB.
Select...
I currently have or recently had a serious infection.
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I have never received treatments targeting IL-12 or IL-23.
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I have been in a study for mirikizumab or received it before.
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I have not had serious or recurring infections in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 71 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 71 days postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the Curve from Zero to Infinity (AUC [ 0 to ∞]) of Mirikizumab
Area under the Curve from Zero to Time to Last Concentration (AUC [0 to tlast]) of Mirikizumab
Maximum Concentration (Cmax) of Mirikizumab

Side effects data

From 2020 Phase 3 trial • 530 Patients • NCT03482011
11%
Upper respiratory tract infection
10%
Nasopharyngitis
7%
Injection site pain
4%
Headache
4%
Cough
4%
Pharyngitis
3%
Gastroenteritis
3%
Arthralgia
3%
Salpingo-oophoritis
3%
Diarrhoea
3%
Hepatic steatosis
3%
Bronchitis
3%
Influenza
3%
Dysmenorrhoea
2%
Malaise
2%
Back pain
2%
Hypertension
2%
Aspartate aminotransferase increased
2%
Gout
2%
Oropharyngeal pain
2%
Erectile dysfunction
2%
Pruritus
2%
Toothache
2%
Urinary tract infection
2%
Ligament sprain
2%
Gamma-glutamyltransferase increased
2%
Alanine aminotransferase increased
1%
Appendicitis
1%
Tinnitus
1%
Oral herpes
1%
Actinic keratosis
1%
Borrelia infection
1%
Drug hypersensitivity
1%
Weight increased
1%
Respiratory tract infection
1%
Epilepsy
1%
Dental caries
1%
Periodontal disease
1%
Typhoid fever
1%
Pyrexia
1%
Acne pustular
1%
Bacteriuria
1%
Conjunctivitis bacterial
1%
Gastroenteritis viral
1%
Gastrointestinal infection
1%
Hepatitis e
1%
Pharyngotonsillitis
1%
Pulpitis dental
1%
Hepatic enzyme increased
1%
Weight decreased
1%
Type 2 diabetes mellitus
1%
Osteoarthritis
1%
Spinal pain
1%
Migraine
1%
Rash
1%
Seborrhoeic dermatitis
1%
Tooth extraction
1%
Abdominal pain lower
1%
Injection site induration
1%
Injection site reaction
1%
Hypersensitivity
1%
Bacterial infection
1%
Postoperative wound infection
1%
Skin laceration
1%
Arthropathy
1%
Muscle spasms
1%
Upper-airway cough syndrome
1%
Dermal cyst
1%
Glomerulonephritis membranous
1%
Vertigo
1%
Injection site swelling
1%
Cholecystitis
1%
Cystitis
1%
Erythema migrans
1%
Folliculitis
1%
Molluscum contagiosum
1%
Arthropod bite
1%
Thermal burn
1%
Blood triglycerides increased
1%
Very low density lipoprotein increased
1%
Skin papilloma
1%
Herpes zoster
1%
Procedural pain
1%
Emphysema
100%
80%
60%
40%
20%
0%
Study treatment Arm
250 mg Miri Q4W Responder to 250 mg Miri Q8W
250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period
250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period
250 mg Miri Q4W Responders to 125 mg Miri Q8W
250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)
Placebo Q4W to Placebo Non-Responder-Follow-up Period
250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period
250 Miri Q4W Discontinued During Induction-Follow-up
250 Miri Q4W to Miri Nonresponder-Follow-up Period
Placebo Q4W
250 mg Miri Q4W
Placebo Q4W to Placebo Q8W (Placebo Responder)
Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)
250 mg Miri Q4W Responders to Placebo Q8W
Relapse
Placebo Q4W to Placebo Q8W (Responder) Follow-up Period
Placebo Q4W Discontinued During Induction-Follow-up Period

Trial Design

2Treatment groups
Experimental Treatment
Group I: Citrate-Free Mirikizumab Autoinjector (Two Injections - Reference)Experimental Treatment1 Intervention
Citrate-Free Mirikizumab administered SC by autoinjector.
Group II: Citrate-Free Mirikizumab Autoinjector (Single Injection - Test)Experimental Treatment1 Intervention
Citrate-Free Mirikizumab administered subcutaneously (SC) by autoinjector.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,221,204 Total Patients Enrolled
Study DirectorEli Lilly and Company
4 Previous Clinical Trials
707 Total Patients Enrolled
~110 spots leftby Nov 2024
Unbiased ResultsWe believe in providing patients with all the options.
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