Clinical Trial Results:
A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (galcanezumab) in Patients with Episodic or Chronic Cluster Headache
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Summary
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EudraCT number |
2015-005234-21 |
Trial protocol |
DE BE FI ES DK NL GR IT |
Global end of trial date |
21 Jan 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
05 Feb 2022
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First version publication date |
05 Feb 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
I5Q-MC-CGAR
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Additional study identifiers
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ISRCTN number |
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US NCT number |
NCT02797951 | ||
WHO universal trial number (UTN) |
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Other trial identifiers |
Trial Number: 16351 | ||
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Sponsors
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Sponsor organisation name |
Eli Lilly and Company
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Sponsor organisation address |
Lilly Corporate Center, Indianapolis, IN, United States, 46285
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Public contact |
Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
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Scientific contact |
Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Jan 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Jan 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
13 Jul 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 17
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Country: Number of subjects enrolled |
Canada: 7
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Country: Number of subjects enrolled |
Denmark: 4
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Country: Number of subjects enrolled |
Finland: 5
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Country: Number of subjects enrolled |
France: 23
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Country: Number of subjects enrolled |
Germany: 25
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Country: Number of subjects enrolled |
Greece: 2
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Country: Number of subjects enrolled |
Italy: 24
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Country: Number of subjects enrolled |
Netherlands: 8
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Country: Number of subjects enrolled |
Spain: 17
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Country: Number of subjects enrolled |
United Kingdom: 4
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Country: Number of subjects enrolled |
United States: 29
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Worldwide total number of subjects |
165
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EEA total number of subjects |
125
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
161
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From 65 to 84 years |
4
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants who completed one of the parent studies I5Q-MC-CGAL (NCT02397473) or I5Q-MC-CGAM (NCT02438826) were enrolled in this study. | ||||||||||||||||||||||
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Pre-assignment
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Screening details |
Participants who continued until sponsor ended the study following regulatory approval or non-approval of study drug for cluster headache indication in a country/region were considered CGAR study completers. | ||||||||||||||||||||||
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Period 1
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Period 1 title |
Galcanezumab 300 mg SC (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||
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Arms
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Arm title
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Galcanezumab 300 mg SC | ||||||||||||||||||||||
Arm description |
Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month. | ||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||
Investigational medicinal product name |
Galcanezumab
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Investigational medicinal product code |
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Other name |
LY2951742
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
300 mg Galcanezumab administered as SC injection up to once a month.
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Baseline characteristics reporting groups
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Reporting group title |
Galcanezumab 300 mg SC
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Reporting group description |
Participants received 300 mg Galcanezumab administered SC up to once a month. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Galcanezumab 300 mg SC
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Reporting group description |
Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month. | ||
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End point title |
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) [1] | ||||||||||
End point description |
A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase.
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.
Analysis Population Description (APD): All participants who received at least one dose of study drug.
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End point type |
Primary
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End point timeframe |
Baseline through End of Study (Up to 4 Years)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) [2] | ||||||||||
End point description |
C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).
- Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent.
- Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.
APD: All participants who received at least one dose of study drug and had at least one postbaseline C-SSRS assessment.
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End point type |
Primary
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End point timeframe |
Baseline through End of Study (Up to 4 Years)
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Participants with Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab | ||||||
End point description |
A participant is consider TE-ADA positive if:
- ADA “not present” baseline result and any subsequent “present” postbaseline ADA result with a titer of at least 1:20 (treatment-induced), or
- ADA “present” baseline result and any subsequent “present” postbaseline ADA result with a 4-fold or greater increase in titer from baseline (treatment-boosted).
APD: All participants who received at least one dose of study drug and had baseline and at least one post baseline ADA assessments.
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End point type |
Secondary
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End point timeframe |
Baseline through End of Study (Up to 4 Years)
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| No statistical analyses for this end point | |||||||
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Adverse events information
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Timeframe for reporting adverse events |
Baseline through End of Study (Up to 4 Years)
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Adverse event reporting additional description |
APD: All participants who received at least one dose of study drug.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.1
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Reporting groups
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Reporting group title |
Galcanezumab 300 mg SC
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Reporting group description |
Participants received 300 mg Galcanezumab administered SC up to once a month. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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15 May 2017 |
1. Amendments were made to the exclusion criteria :
- to allow for medical judgment in determining exclusion from Study CGAR based on abnormal ECG findings, blood pressure readings in Study CGAL or Study CGAM.
- to allow participants with a history of intracranial tumor or head trauma to be enrolled in the study based on medical discretion.
- to allow participants who fail eligibility due to an elevation of ≥2X ULN for ALT, or ≥1.5X ULN TBL or ALP to be retested and enrolled based on medical discretion if the results are not clinically significant.
- to allow for rescreening of patients who fail eligibility due to a positive urine drug screen.
2. Amended the protocol to clarify study discontinuation for those patients whose dosing is temporarily interrupted for potential safety concerns. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
