Clinical Trial Results:
An Open Label Extension Trial Assessing the Safety and Efficacy of BI 655066/ABBV-066/Risankizumab Administered Subcutaneously in Patients with Moderate to Severe Chronic Plaque Psoriasis
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Summary
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EudraCT number |
2014-001687-36 |
Trial protocol |
FI DE |
Global end of trial date |
04 Sep 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Aug 2019
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First version publication date |
01 Aug 2019
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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 |
1311.13 (M16-009)
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Boehringer Ingelheim
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Sponsor organisation address |
Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
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Public contact |
QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 800 243 0127, clintriage.rdg@boehringer-ingelheim.com
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Scientific contact |
QRPE Processes and Systems Coordination Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 800 243 0127, clintriage.rdg@boehringer-ingelheim.com
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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 |
26 Sep 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Sep 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Sep 2018
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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 primary objective of Study M16-009 was to investigate the safety of risankizumab in participants with moderate to severe chronic plaque psoriasis who were receiving long-term treatment. Additional study objectives were to further investigate the long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of risankizumab.
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Protection of trial subjects |
Only participants that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All participants were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all participants was adhered to throughout the trial conduct. Rescue medication was allowed for all participants as required.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Nov 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Canada: 28
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Country: Number of subjects enrolled |
France: 9
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Country: Number of subjects enrolled |
Germany: 6
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Country: Number of subjects enrolled |
United States: 67
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Worldwide total number of subjects |
110
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EEA total number of subjects |
15
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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) |
98
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From 65 to 84 years |
12
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||
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Pre-assignment
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Screening details |
Participants who completed Study 1311.2 (lead-in study) and met eligibility criteria for this study were enrolled. At Week 12, those with ≥90% improvement in Psoriasis Area and Severity Index (PASI90) Score continued risankizumab 90 mg by subcutaneous (SC) injection; those with <PASI90 Score switched to risankizumab 180 mg by SC injection. | ||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
Blinding implementation details |
This is a Phase 2, multicenter, open-label extension (OLE) study.
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Arms
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Arm title
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Risankizumab 90 mg or 180 mg | ||||||||||||||
Arm description |
Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for 4 years. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Risankizumab 180 mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Participants received open-label (OL) risankizumab 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for 4 years.
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Investigational medicinal product name |
Risankizumab 90 mg
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Participants received open-label (OL) risankizumab 90 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for 4 years.
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Baseline characteristics reporting groups
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Reporting group title |
Risankizumab 90 mg or 180 mg
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Reporting group description |
Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for 4 years. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Risankizumab 90 mg or 180 mg
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Reporting group description |
Participants received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection at Week 12 and every 12 weeks for 4 years. | ||
Subject analysis set title |
Risankizumab 90 mg
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years.
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Subject analysis set title |
Risankizumab 180 mg
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years.
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Subject analysis set title |
Risankizumab 18 mg/Risankizumab
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants who received risankizumab 18 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for 4 years.
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Subject analysis set title |
Risankizumab 90 mg/Risankizumab
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants who received risankizumab 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for 4 years.
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Subject analysis set title |
Risankizumab 180 mg/Risankizumab
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants who received risankizumab 180 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for 4 years.
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Subject analysis set title |
Ustekinumab/Risankizumab
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants who received ustekinumab 45 mg or 90 mg in the lead-in study received open-label (OL) risankizumab 90 mg or 180 mg by subcutaneous (SC) injection in this study at Week 12 and every 12 weeks for 4 years.
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End point title |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [1] | |||||||||
End point description |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related, not related. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAE/TESAEs are any events with an onset after the first dose of risankizumab in this study. See the AE section for details. Safety population is defined as all participants who received at least one dose of study drug in the study.
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End point type |
Primary
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End point timeframe |
From the first dose of study drug until 12 weeks after the last dose of study drug (up to 4.5 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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested. |
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| Notes [2] - Safety population. Safety population is same as ITT [3] - Safety population |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Number of Participants with Drug-related TEAEs [4] | |||||||||
End point description |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the AE section for details.
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End point type |
Primary
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End point timeframe |
From the first dose of study drug until 12 weeks after the last dose of study drug (up to 4.5 years)
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| Notes [4] - 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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested. |
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| Notes [5] - Safety population [6] - Safety population |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) [7] | |||||||||
End point description |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event with an onset after the first dose of risankizumab in this study. See the AE section for details.
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End point type |
Primary
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End point timeframe |
From the first dose of study drug until 12 weeks after the last dose of study drug (up to 4.5 years)
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| Notes [7] - 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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested. |
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| Notes [8] - Safety population [9] - Safety population |
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| No statistical analyses for this end point | ||||||||||
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End point title |
Percentage of Participants Achieving 90% improvement in Psoriasis Area and Severity Index (PASI90) score at week 48 in the Extended dosing period [10] | ||||||||||||||||||||
End point description |
Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
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End point type |
Primary
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End point timeframe |
Baseline, Week 48
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| Notes [10] - 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: This endpoint was evaluated only descriptively. Thus, no statistical hypothesis were tested. |
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| Notes [11] - ITT [12] - ITT [13] - ITT [14] - ITT |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Participants achieving Static Physician Global Assessment (sPGA) of clear or almost clear at Week 48 of Extended Dosing period | ||||||||||||||||||||
End point description |
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.
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End point type |
Secondary
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End point timeframe |
Week 48
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| Notes [15] - ITT [16] - ITT [17] - ITT [18] - ITT |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Participants Achieving 50% Improvement in PASI (PASI50) Score at week 48 in the Extended dosing period | ||||||||||||||||||||
End point description |
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI50 is defined as at least a 50% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 48
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| Notes [19] - ITT [20] - ITT [21] - ITT [22] - ITT |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Participants Achieving 75% Improvement in PASI (PASI75) Score at week 48 in the Extended dosing period | ||||||||||||||||||||
End point description |
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 48
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| Notes [23] - ITT [24] - ITT [25] - ITT [26] - ITT |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Participants Achieving 100% Improvement in PASI (PASI100) Score at week 48 in the Extended dosing period | ||||||||||||||||||||
End point description |
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. Baseline PASI for this study is defined as the baseline PASI in the lead-in study. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 48
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| Notes [27] - ITT [28] - ITT [29] - ITT [30] - ITT |
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Percentage of Participants achieving sPGA of clear at Week 48 of Extended Dosing period | ||||||||||||||||||||
End point description |
The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. Baseline is defined as the last non-missing value on or before the date of the first dose of study drug in the lead-in study.
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End point type |
Secondary
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End point timeframe |
Week 48
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| Notes [31] - ITT [32] - ITT [33] - ITT [34] - ITT |
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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 |
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 12 weeks after the last dose of study drug (up to 4.5 years).
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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 |
21.0
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Reporting groups
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Reporting group title |
Risankizumab 90 mg
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Reporting group description |
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had ≥ PASI 90 at week 12 continued to receive risankizumab 90 mg at Week 12 and every 12 weeks for 4 years. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Risankizumab 180 mg
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Reporting group description |
Participants entered the study receiving risankizumab 90 mg by subcutaneous (SC) injection and had < PASI 90 at week 12 switched to risankizumab 180 mg at Week 12 and every 12 weeks for 4 years. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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26 Sep 2014 |
Modification of study duration and maximum administration of study drug from approximately 4 years to 1 calendar year; deletion of text describing possible dose adjustment, due to the removal of the risankizumab 180 mg dose; addition of further description of signs of hypersensitive reactions; addition of PASI 75 as a standard clinical endpoint; and removal of the erythrocyte sedimentation rate test. |
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15 Oct 2014 |
Administrative changes to clarify timing of visits, study procedures for drug administrations, withdrawals, and collection of vital signs and vital status follow-up, as well as the removal of the tolerability assessment since only 1 dose was being administered. |
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10 Jun 2015 |
Return to the original protocol wording allowing a maximum study duration of approximately 4 years and the potential for dose adjustment to risankizumab 180 mg as needed, based on availability of new toxicity data. In addition, a new visit schedule for an extended dosing period and a new residual effect period were implemented, as well as a change to the specification of visits for electrocardiograms (ECGs). |
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12 Oct 2016 |
The change in study sponsor from Boehringer-ingelheim (BI) to AbbVie and associated revisions resulting from this change. |
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30 Jan 2018 |
The decision to end the current study and transition subjects who had not previously prematurely discontinued to open-label treatment in Study M15-997, as well as changes to the serum pregnancy and tuberculosis (TB) screening requirements for the end of study (EOS) visit for Study M16-009. |
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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 | |||
