Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis

Plaque Psoriasis Clinical Trial

— UNCOVER-A  

Official title:

Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777191
• Other study ID #: 14728
• Secondary ID: I1F-MC-RHBL
• Status: Completed
• Phase: Phase 3
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: May 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization

• At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization

• Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization

• Candidate for phototherapy and/or systemic therapy

• Men must agree to use a reliable method of birth control during the study

• Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion Criteria:

• Pustular, erythrodermic, and/or guttate forms of psoriasis

• History of drug-induced psoriasis

• Clinically significant flare of psoriasis during the 12 weeks prior to randomization

• Concurrent or recent use of any biologic agent

• Received systemic psoriasis therapy [such as psoralen and ultraviolet A (PUVA) light therapy] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization

• Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study

• Have participated in any study with interleukin-17 (IL-17) antagonists, including Ixekizumab

• Serious disorder or illness other than plaque psoriasis

• Serious infection within the last 3 months

• Breastfeeding or nursing (lactating) women

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Ixekizumab Auto-Injector
Administered SC by auto-injector
• Ixekizumab Prefilled Syringe
Administered SC by prefilled syringe

Locations

Country	Name	City	State
Puerto Rico	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Caguas
Puerto Rico	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Carolina
Puerto Rico	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ponce
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Albuquerque	New Mexico
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Anaheim	California
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Arlington Heights	Illinois
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Atlanta	Georgia
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bakersfield	California
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	East Windsor	New Jersey
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Evansville	Indiana
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Exton	Pennsylvania
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Greensboro	North Carolina
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lake Charles	Louisiana
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Louisville	Kentucky
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Methuen	Massachusetts
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Miami	Florida
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Newington	New Hampshire
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Newnan	Georgia
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ocala	Florida
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Omaha	Nebraska
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Saint Louis	Missouri
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Salt Lake City	Utah
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Santa Monica	California
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Seattle	Washington
United States	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Callis Duffin K, Bagel J, Bukhalo M, Mercado Clement IJ, Choi SL, Zhao F, Gill A, Pangallo B, Shuler C, Mallbris L, Jackson K. Phase 3, open-label, randomized study of the pharmacokinetics, efficacy and safety of ixekizumab following subcutaneous administ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device	Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Primary	PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device	AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Secondary	PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)	Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Secondary	PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)	AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Secondary	PK: Cmax by Body Weight	Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: <80 kilogram (kg), Medium: 80-100 kg, or High: >100 kg).	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Secondary	PK: AUC 0-tlast by Body Weight	AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: <80 kg, Medium: 80-100 kg, or High: >100 kg).	Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Secondary	Percentage of Participants Achieving a =75%, = 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)	PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline.	Week 12
Secondary	Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA)	The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.	Week 12
Secondary	Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)	The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).	Week 12
Secondary	Percentage of Device Operation Failures	Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use.	Baseline through Week 12
Secondary	Percentage of Participants With Anti-Ixekizumab Antibodies	The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.	Baseline to Week 12
Secondary	SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)	The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree"). 1 represents "Strongly Disagree" while 7 represents "Strongly Agree". The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit.	Baseline, Week 4 and Week 8