A Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P1)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT01695239

First received: September 25, 2012

Last updated: September 6, 2016

Last verified: September 2016

History of Changes

Results First Received: April 20, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Psoriasis, Arthritic
Interventions:	Drug: Ixekizumab Drug: Placebo Drug: Adalimumab

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized to treatment at Week 0 and entered the Double-Blind Treatment Period (Week 0 up to Week 24).

Reporting Groups

	Description
Placebo	Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.
Adalimumab Q2W	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Ixekizumab Q4W	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Ixekizumab Q2W	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.

Participant Flow: Overall Study

	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W
STARTED	106	101	107	103
Received at Least 1 Dose of Study Drug	106	101	107	102
Classified as Inadequate Responder (IR)	27	9	11	10
COMPLETED	91	97	97	97
NOT COMPLETED	15	4	10	6
On Study Treatment	0	0	1	0
Entry Criteria Not Met	1	1	3	3
Adverse Event	2	2	2	3
Lack of Efficacy	4	0	2	0
Withdrawal by Subject	3	1	1	0
Sponsor Decision	3	0	1	0
Lost to Follow-up	1	0	0	0
Protocol Violation	1	0	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo	Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
Adalimumab Q2W	Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
Ixekizumab Q4W	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Ixekizumab Q2W	Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Adalimumab Q2W	Ixekizumab Q4W	Ixekizumab Q2W	Total
Overall Participants Analyzed [Units: Participants]	106	101	107	103	417

Age [Units: Years] Mean (Standard Deviation)	50.60 (12.32)	48.58 (12.43)	49.07 (10.07)	49.79 (12.62)	49.52 (11.87)

Gender [Units: Participants]
Female	58	50	62	55	225
Male	48	51	45	48	192

Race (NIH/OMB) [Units: Participants]
American Indian or Alaska Native	2	3	2	2	9
Asian	5	3	2	5	15
Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Black or African American	0	0	0	0	0
White	99	95	102	96	392
More than one race	0	0	1	0	1
Unknown or Not Reported	0	0	0	0	0

Race/Ethnicity, Customized [Units: Participants]
Hispanic or Latino	6	5	5	4	20
Not Hispanic or Latino	92	83	94	87	356
Unknown or Not Reported	8	13	8	12	41

Region of Enrollment [Units: Participants]
Russian Federation	9	7	10	8	34
United States	22	21	20	20	83
Japan	4	2	2	4	12
Ukraine	9	7	9	10	35
United Kingdom	3	5	5	4	17
Spain	4	2	3	4	13
Canada	1	1	2	0	4
Czech Republic	22	25	23	22	92
Netherlands	1	0	1	0	2
Belgium	2	2	0	1	5
Poland	16	14	15	15	60
Mexico	3	4	3	2	12
France	1	0	1	1	3
Bulgaria	3	4	5	4	16
Estonia	6	7	8	8	29

Outcome Measures

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1. Primary:

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) [ Time Frame: Week 24 ]

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2. Secondary:

Percentage of Participants Achieving ACR20 Response at Week 12 [ Time Frame: Week 12 ]

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3. Secondary:

Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 [ Time Frame: Week 24 ]

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4. Secondary:

Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Score at Week 24 [ Time Frame: Week 24 ]

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5. Secondary:

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) [ Time Frame: Baseline, Week 24 ]

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6. Secondary:

Change From Baseline in Modified Total Sharp Score (mTSS) (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: Modified Total Sharp Score [mTSS]) [ Time Frame: Baseline, Week 24 ]

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7. Secondary:

Percentage of Participants Achieving Psoriasis Area and Severity Index 75%, 90%, 100% (PASI 75, 90, 100) [ Time Frame: Week 12 ]

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8. Secondary:

Change From Baseline in Leeds Enthesitis Index (LEI) [ Time Frame: Baseline, Week 12 ]

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9. Secondary:

Change From Baseline in Itching Severity Using the Itch Numeric Rating Scale (NRS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) [ Time Frame: Baseline, Week 12 ]

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10. Secondary:

Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) [ Time Frame: Baseline, Week 24 ]

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11. Secondary:

Change From Baseline in Joint Space Narrowing Score (JSN) And Bone Erosion Score (BES) [ Time Frame: Baseline, Week 24 ]

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12. Secondary:

Change From Baseline in Medical Outcomes Study 36-item Short Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) (Quality of Life and Outcome Assessments Measures: Participant Reported Outcomes [PRO]) [ Time Frame: Baseline, Week 24 ]

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13. Secondary:

Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) (Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes [PRO]) [ Time Frame: Baseline, Week 24 ]

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14. Secondary:

Change From Baseline in Disease Activity Score (28 Diarthrodial Joint Count) Based on C-ReactiveProtein (DAS28-CRP) Measure: Non-Arthritic Disease [ Time Frame: Baseline, Week 24 ]

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15. Secondary:

Percentage of Participants Meeting the Psoriatic Arthritis Response Criteria (PsARC Modified) [ Time Frame: Week 24 ]

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16. Secondary:

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of 0 or 1 and With at Least a 2-point Improvement From Baseline [ Time Frame: Week 24 ]

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17. Secondary:

Percent Change From Baseline in Body Surface Area (BSA) [ Time Frame: Baseline, Week 24 ]

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18. Secondary:

Change From Baseline in the Nail Psoriasis Severity Index (NAPSI) Score Fingernail Involvement at Baseline [ Time Frame: Baseline, Week 24 ]

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19. Secondary:

Change From Baseline in Leeds Dactylitis Index-Basic (LDI-B) [ Time Frame: Baseline, Week 24 ]

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20. Secondary:

Change From Baseline in in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Week 24 ]

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21. Secondary:

Number of Participants With Treatment Emergent Anti-Ixekizumab Antibodies (TE-ADA) and Neutralizing Antibodies (NAb) [ Time Frame: Baseline to Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mease PJ, van der Heijde D, Ritchlin CT, Okada M, Cuchacovich RS, Shuler CL, Lin CY, Braun DK, Lee CH, Gladman DD; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017 Jan;76(1):79-87. doi: 10.1136/annrheumdis-2016-209709. Epub 2016 Aug 23.

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01695239 History of Changes
Other Study ID Numbers:	13731 I1F-MC-RHAP ( Other Identifier: Eli Lilly and Company )
Study First Received:	September 25, 2012
Results First Received:	April 20, 2016
Last Updated:	September 6, 2016

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