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Monoclonal Antibodies

Mirikizumab for Psoriasis

Phase 3
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 104
Awards & highlights

Summary

This trial will test the safety and effectiveness of a new plaque psoriasis drug over a long period of time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 104 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 Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those Who Entered the Study With a PASI 90
Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1
Secondary outcome measures
Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
+3 more

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%
Actinic keratosis
1%
Tinnitus
1%
Borrelia infection
1%
Oral herpes
1%
Weight increased
1%
Drug hypersensitivity
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 Responders to 125 mg Miri Q8W
250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period
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

3Treatment groups
Experimental Treatment
Group I: Secukinumab/250 mg Mirikizumab Q8WExperimental Treatment1 Intervention
Participants from previous originating study \[who received secukinumab (AMAJ)\] received 250 mg mirikizumab administered SC Q8W.
Group II: 250 mg Mirikizumab Q8W Excluding SecukinumabExperimental Treatment1 Intervention
Participants received 250 mg mirikizumab administered SC Q8W excluding participants who received secukinumab of their originating study (AMAJ)
Group III: 125 Milligram (mg) Mirikizumab Q8WExperimental Treatment1 Intervention
Participants received 125 mg mirikizumab administered subcutaneously (SC) every eight weeks (Q8W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab
2020
Completed Phase 3
~6070

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,640 Previous Clinical Trials
3,219,708 Total Patients Enrolled
36 Trials studying Psoriasis
18,467 Patients Enrolled for Psoriasis
1-877-CTLILLY (1-877-285-4559) or Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
~277 spots leftby Sep 2025
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