PsoriasisPhase 1NCT03073213

A Study of Ixekizumab in Chinese Participants With Psoriasis Vulgaris

A Phase 1 study testing Ixekizumab in people with Psoriasis, run by Eli Lilly and Company at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Psoriasis
What is being tested?: Ixekizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 3 sitesChina
Study dates: 13 Apr 2017to 14 May 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females aged ≥18 years.
Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.
Candidates for phototherapy and/or systemic therapy.
≥10% body surface area (BSA) involvement at screening and baseline.
static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.

Who cannot join

Clinically significant flare of psoriasis during the 12 weeks before baseline.
Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline .
Current or recent use of any biologic agent within the required washout periods.
Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Xiangya Hospital, Central South University
Changsha, Hunan
Second Affiliate Hospital of Zhejiang Medical University
Hangzhou, Zhejiang, 310009
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, 200025

Other trials in China

About this study

Official title: A Phase 1, Single- and Multiple-Dose Study to Assess the Safety and Pharmacokinetics of Ixekizumab (LY2439821) (Anti-IL-17 Humanized Antibody) in Chinese Patients With Psoriasis Vulgaris

The purpose of the study is to research how much ixekizumab enters the bloodstream and how long the body takes to get rid of the drug and the safety of ixekizumab and any side effects that might be associated with it. The study has two parts: A single-dose part and multiple-dose part. The single dose part of this study will last up to 24 weeks, including the screening period. The multiple dose part of this study will last up to 32 weeks including the screening period.

Conditions: Psoriasis
Being tested: Ixekizumab
Medical subject headings: Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IxekizumabDrug
Also called LY2439821
Administered as subcutaneous (SC) injection

Study groups in NCT03073213
Study group	Role	What they receive
Ixekizumab single dose	Experimental	Participants received single dose of 80mg Ixekizumab by subcutaneous injection. Receives: Drug: Ixekizumab
Ixekizumab Multiple Regimen 1 (80mg Q2W)	Experimental	Participants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection. Receives: Drug: Ixekizumab
Ixekizumab Multiple Regimen 2 (80mg Q4W)	Experimental	Participants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection. Receives: Drug: Ixekizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Measured: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
Measured: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.
Measured: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197
Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)
Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).
Measured: day 57 (Pre-dose), 59, 61, 64, 67, 71
Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)
Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).
Measured: day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 201714 May 2019

First posted8 Mar 2017
Study start13 Apr 2017
Primary completion14 May 2019
Study completion14 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PsoriasisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03073213
Sponsor's protocol ID: 15371
Other IDs: I1F-MC-RHBN
Status last verified: 1 Jun 2019
First submitted: 3 Mar 2017
Last updated: 22 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Zheng M, Chen X, Wang F, Chen J, Jackson K, Yang F, Payne C, Li H, Wang Y, Xiao Z, Zheng J. Pharmacokinetics, Safety, and Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 1, Single- and Multiple-Dose Study. Adv Ther. 2023 Sep;40(9):3804-3816. doi: 10.1007/s12325-023-02575-1. Epub 2023 Jun 25.
PubMed 37356077

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

All Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single- and Multiple-Dose Study to Assess the Safety and Pharmacokinetics of Ixekizumab (LY2439821) (Anti-IL-17 Humanized Antibody) in Chinese Patients With Psoriasis Vulgaris
ClinicalTrials.gov ID: NCT03073213
Acronym / sponsor ID: 15371
Conditions: Psoriasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 13 Apr 2017 (actual)
Primary completion: 14 May 2019 (actual)
Study completion: 14 May 2019 (actual)
First posted: 8 Mar 2017 (actual)
Results: Posted 22 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Ixekizumab single dose	Experimental	Drug: IxekizumabParticipants received single dose of 80mg Ixekizumab by subcutaneous injection.
Ixekizumab Multiple Regimen 1 (80mg Q2W)	Experimental	Drug: IxekizumabParticipants received multiple doses of Ixekizumab starting with 160mg initial dose followed by 80mg every two weeks (Q2W) by subcutaneous injection.
Ixekizumab Multiple Regimen 2 (80mg Q4W)	Experimental	Drug: IxekizumabParticipants received multiple doses of 80mg Ixekizumab starting with 160mg initial dose followed by 80mg every four weeks (Q4W) by subcutaneous injection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Males or females aged ≥18 years.
Diagnosis of chronic plaque psoriasis for ≥6 months before baseline.
Candidates for phototherapy and/or systemic therapy.
≥10% body surface area (BSA) involvement at screening and baseline.
static Physician's Global Assessment (sPGA) score ≥3, and Psoriasis Area and Severity Index (PASI) score ≥12 at screening and baseline.

Key exclusion criteria (4 listed)

Clinically significant flare of psoriasis during the 12 weeks before baseline.
Systemic nonbiologic psoriasis therapy or phototherapy within 4 weeks. prior to baseline or topical psoriasis treatment or medicated shampoo within 2 weeks prior to baseline .
Current or recent use of any biologic agent within the required washout periods.
Clinical evidence or suspicion of active tuberculosis or previously had evidence of active tuberculosis and did not receive appropriate and documented treatment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IxekizumabAlso: LY2439821Administered as subcutaneous (SC) injection	Drug	Ixekizumab Multiple Regimen 1 (80mg Q2W), Ixekizumab Multiple Regimen 2 (80mg Q4W), Ixekizumab single dose

Primary outcome

Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)
Time frame: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Pharmacokinetics (PK): Cmax is the maximum observed concentration of Ixekizumab into serum.
Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)
Time frame: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) from time zero to infinity was reported.
Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)
Time frame: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197
Pharmacokinetics: Cmax is the maximum observed concentration of Ixekizumab into serum.
Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)
Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71
Pharmacokinetics: Area under concentration of Ixekizumab from time Zero to 336h (AUC 0 to 336h) was reported (Multiple dose).
Pharmacokinetics: Area Under Concentration From Time Zero to 672h (AUC 0 to 672h) of Ixekizumab (Multiple Dose)
Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71, 78, 85
Pharmacokinetics: Area under concentration of Ixekizumab from time zero to 672h (AUC 0 to 672h) was reported (Multiple dose).

Results and safety

Results posted to the registry on 22 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ixekizumab Single Dose	12	12
Ixekizumab 80mg Q2W Multiple Dose	0	0
Ixekizumab 80mg Q4W Multiple Dose	0	0

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose)

Time frame: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141. Geometric mean (Geometric Coefficient of Variation). Unit: Microgram per milliliter (ug/mL)

Measure	Ixekizumab Single Dose n = 12
Value	6.90 (43)

Population analysed: All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.

Primary outcome: Pharmacokinetics: Area Under Concentration From Time Zero to Infinity (AUC 0toinf) of Ixekizumab (Single Dose)

Time frame: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141. Geometric mean (Geometric Coefficient of Variation). Unit: Microgram*day per milliliter (ug*day/mL)

Measure	Ixekizumab Single Dose n = 12
Value	147 (48)

Population analysed: All randomized participants who received at least one dose of Ixekizumab in single dose group and had evaluable PK data.

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Multiple Dose)

Time frame: day 57 (pre-dose), 59, 61, 64, 67, 71, 78, 85, 99, 113, 141, 169, 197. Geometric mean (Geometric Coefficient of Variation). Unit: Microgram per milliliter (ug/mL)

Measure	Ixekizumab 80mg Q2W Multiple Dose n = 14	Ixekizumab 80mg Q4W Multiple Dose n = 14
Value	19.9 (27)	13.4 (32)

Population analysed: All randomized participants who received at least one dose of Ixekizumab in multiple dose group and had evaluable PK data.

Primary outcome: Pharmacokinetics: Area Under Concentration From Time Zero to 336h (AUC 0 to 336h) of Ixekizumab (Multiple Dose)

Time frame: day 57 (Pre-dose), 59, 61, 64, 67, 71. Geometric mean (Geometric Coefficient of Variation). Unit: Microgram*day per milliliter (ug*day/mL)

Measure	Ixekizumab 80mg Q2W Multiple Dose n = 14	Ixekizumab 80mg Q4W Multiple Dose n = 14
Value	224 (25)	136 (31)

Population analysed: All randomized participants multiple dose period who received at least one dose of Ixekizumab and had evaluable PK data.

Adverse events

Time frame: Baseline to end of the study (up to 20 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ixekizumab Single Dose	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Ixekizumab 80mg Q2W Multiple Dose	1 of 14 (7.1%)	11 of 14 (78.6%)	0 of 14
Ixekizumab 80mg Q4W Multiple Dose	0 of 15 (0%)	12 of 15 (80%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37356077Zheng M, Chen X, Wang F, Chen J, Jackson K, Yang F, Payne C, Li H, Wang Y, Xiao Z, Zheng J. Pharmacokinetics, Safety, and Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Plaque Psoriasis: A Phase 1, Single- and Multiple-Dose Study. Adv Ther. 2023 Sep;40(9):3804-3816. doi: 10.1007/s12325-023-02575-1. Epub 2023 Jun 25.

Related trials for Psoriasis

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ixekizumab in people with Psoriasis, run by Eli Lilly and Company at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics: Maximum Concentration (Cmax) of Ixekizumab (Single Dose) (time frame: Single dose: Predose, day 1, 3, 5, 8, 11, 15, 22, 29, 43, 57, 85, 113, 141). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03073213, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.