Clinical Trial Results:
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ANB019 in the Treatment of Acneiform Rash in Subjects with Neoplasm Receiving EGFRi or MEKi Therapy
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Summary
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EudraCT number |
2020-003494-22 |
Trial protocol |
PL CZ LV BG HU |
Global end of trial date |
13 Dec 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Jan 2023
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First version publication date |
20 Jan 2023
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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 |
ANB019-207
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04697069 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
AnaptysBio, Inc
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Sponsor organisation address |
10770 Wateridge Circle, Suite 210, San Diego, CA, United States, 92121
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Public contact |
Bruce Randazzo, AnaptysBio Inc., 001 (858) 362-6343, brandazzo@anaptysbio.com
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Scientific contact |
Bruce Randazzo, AnaptysBio Inc., 001 (858) 362-6343, brandazzo@anaptysbio.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 |
13 Dec 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 |
13 Dec 2021
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the efficacy of imsidolimab (ANB019) compared with placebo in the reduction of acneiform rash in participants receiving epidermal growth factor receptor inhibitor (EGFRi) or mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK) kinase inhibitor (MEKi) therapy as measured by the facial inflammatory lesion count.
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Protection of trial subjects |
This study was performed in compliance with ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice (GCP) and the applicable laws and regulations.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 May 2021
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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 |
Poland: 1
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Country: Number of subjects enrolled |
Czechia: 1
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Country: Number of subjects enrolled |
Georgia: 2
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Worldwide total number of subjects |
4
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EEA total number of subjects |
2
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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) |
3
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
Participants with neoplasms who were receiving epidermal growth factor inhibitors or mitogen-activated protein/extracellular signal regulated kinase inhibitor were enrolled into the study. | ||||||||||||||||||
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Pre-assignment
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Screening details |
11 participants were screened for eligibility and 4 participants were randomized into the study. | ||||||||||||||||||
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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 |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator, Carer, Assessor | ||||||||||||||||||
Blinding implementation details |
The Sponsor, Investigator, and participants were blinded to treatment assignment of imsidolimab or placebo. An unblinded pharmacist was responsible for study treatment dispensing.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Imsidolimab | ||||||||||||||||||
Arm description |
Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Imsidolimab
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Investigational medicinal product code |
ANB019
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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 |
Imsidolimab was administered by clinic staff trained in best practices for subcutaneous administration at starting dose of on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85).
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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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 |
Placebo matched to imsidolimab was administered by clinic staff trained in best practices for subcutaneous administration on Days 1, 29, 57 and 85.
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Baseline characteristics reporting groups
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Reporting group title |
Imsidolimab
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Reporting group description |
Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Imsidolimab
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Reporting group description |
Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | ||
Reporting group title |
Placebo
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Reporting group description |
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | ||
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End point title |
Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8 [1] | ||||||||||||
End point description |
The number of facial inflammatory lesions (papules and pustules) on the face (excluding the neck and scalp area) was counted. Papule was a small, solid elevation 5 millimeters (mm) or less in diameter. Pastule was a small, circumscribed elevation of the skin that contains yellow-white exudate.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Primary
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End point timeframe |
Baseline, Week 8
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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 statistical analysis was performed for the primary endpoint. Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification. |
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| Notes [2] - Due to early study termination, no participant was evaluated [3] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percent Change From Baseline in Facial Inflammatory Lesion Count (Papules and Pustules) at Week 8 | ||||||||||||
End point description |
The number of facial inflammatory lesions (papules and pustules) on the face (excluding the neck and scalp area) was counted. Papule was a small, solid elevation 5 mm or less in diameter. Pastule was a small, circumscribed elevation of the skin that contains yellow-white exudate.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [4] - Due to early study termination, no participant was evaluated. [5] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Common Terminology Criteria for Adverse Events (CTCAE) Grading Scale at Week 8 | ||||||||||||
End point description |
The acneiform rash CTCAE grading scale of severity was 6-point scale ranging from 0-5.
Scale 0=no evidence of rash.
Scale 1=papules and/or pustules covering <10% body surface area (BSA),which may or may not be associated with symptoms of pruritus or tenderness.
Scale 2=papules and/or pustules covering 10-30% BSA, which may or may not be associated with symptoms of pruritus
or tenderness; associated with psychosocial impact;limiting instrumental activities of daily living (ADL); papules and/or
pustules covering >30% BSA with or without mild symptoms.
Scale 3=papules and/or pustules covering >30% BSA with moderate or severe symptoms; limiting self-care ADL;
associated with local superinfection with oral antibiotics.
Scale 4=life-threatening consequences; papules and/or pustules covering any %BSA, which may or may not be
associated with symptoms of pruritus or tenderness and are associated with extensive superinfection with intravenous
(IV) antibiotics indicated.
Scale 5=death
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [6] - Due to early study termination, no participant was evaluated. [7] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash CTCAE Grading Scale | ||||||||||||
End point description |
Time to first response of 1 grade improvement from baseline on the acneiform rash CTCAE grading scale: Date of the first response of 1 grade improvement from baseline on the acneiform rash CTCAE grading scale – Date of the first dose of study treatment (or from randomization for any participant randomized but not treated) + 1.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline up to 55 days
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| Notes [8] - Due to early study termination, no participant was evaluated. [9] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified Multinational Association for Supportive Care in Cancer (MASCC) EGFRi Skin Toxicity Tool (MESTT) Grading Scale (Total Score) at Week 8 | ||||||||||||
End point description |
The MESTT grading scale of the acneiform rash severity was a 3-point scale ranging from 1 to 3:
Scale 1 = 1A: papules or pustules ≤5; OR 1 area of erythema or edema <1 centimeter (cm) in size. 1B: papules or
pustules ≤5; OR 1 area of erythema or edema <1 cm in size; AND pain or pruritus.
Scale 2 = 2A: papules or pustules 6-20; OR 2-5 areas of erythema or edema <1 cm in size. 2B: Papules or pustules
6-20; OR 2-5 areas of erythema or edema <1 cm in size; AND pain, pruritus, or effect on emotions or functioning.
Scale 3 = 3A: papules or pustules > 20; OR more than 5 areas of erythema or edema <1 cm in size. 3B: papules or
pustules > 20; OR more than 5 areas of erythema or edema <1 cm in size; AND pain, pruritus, or effect on emotions or
functioning.
Grading was performed individually for the face, scalp, chest, and back. The sum of all body region scores yielded the
total score (range: 4 to 12).
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [10] - Due to early study termination, no participant was evaluated. [11] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Total Score) | ||||||||||||
End point description |
Time to first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (total score): Date of onset of the first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale (total score) – Date of the first dose of study treatment (or from randomization for any participant randomized but not treated) + 1.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline to 55 days
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| Notes [12] - Due to early study termination, no participant was evaluated. [13] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With an Improvement of at Least 1 Grade From Baseline in Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) at Week 8 | ||||||||||||
End point description |
The MESTT grading scale of the acneiform rash severity was a 3-point scale ranging from 1 to 3:
Scale 1 = 1A: papules or pustules ≤5; OR 1 area of erythema or edema <1cm in size. 1B: papules or pustules ≤5; OR 1
area of erythema or edema <1 cm in size; AND pain or pruritus.
Scale 2 = 2A: papules or pustules 6-20; OR 2-5 areas of erythema or edema <1 cm in size. 2B: Papules or pustules
6-20; OR 2-5 areas of erythema or edema <1 cm in size; AND pain, pruritus, or effect on emotions or functioning.
Scale 3 = 3A: papules or pustules > 20; OR more than 5 areas of erythema or edema <1 cm in size. 3B: papules or
pustules > 20; OR more than 5 areas of erythema or edema <1 cm in size; AND pain, pruritus, or effect on emotions or
functioning.
Grading was performed individually for the face. The score ranged from 1 to 3.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [14] - Due to early study termination, no participant was evaluated. [15] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to First Response of 1 Grade Improvement From Baseline on the Acneiform Rash Modified MESTT Grading Scale (Facial Assessment) | ||||||||||||
End point description |
Time to first response of 1 grade improvement from baseline on the acneiform rash modified MESTT grading scale
(facial assessment): Date of onset of the first response of 1 grade improvement from baseline on the acneiform rash
modified MESTT grading scale (facial assessment) – Date of the first dose of study treatment (or from randomization for
any participant randomized but not treated) + 1.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline to 55 days
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| Notes [16] - Due to early study termination, no participant was evaluated. [17] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 8 | ||||||||||||
End point description |
The intensity of pruritus was evaluated by asking participants to assign a numerical score representing the worst
intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the
worst imaginable itch.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [18] - Due to early study termination, no participant was evaluated. [19] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percent Change From Baseline in Pruritus NRS at Week 8 | ||||||||||||
End point description |
The intensity of pruritus was evaluated by asking participants to assign a numerical score representing the worst
intensity over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the
worst imaginable itch.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [20] - Due to early study termination, no participant was evaluated. [21] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Pain NRS at Week 8 | ||||||||||||
End point description |
The intensity of pain was evaluated by asking participants to assign a numerical score representing the worst intensity
over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst
imaginable pain.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [22] - Due to early study termination, no participant was evaluated. [23] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percent Change From Baseline in Pain NRS at Week 8 | ||||||||||||
End point description |
The intensity of pain was evaluated by asking participants to assign a numerical score representing the worst intensity
over the last 24 hours of their symptoms on a scale from 0 to 10, with 0 indicating no pain and 10 indicating the worst
imaginable pain.
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [24] - Due to early study termination, no participant was evaluated. [25] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Functional Assessment of Cancer Therapy - Epidermal Growth Factor Receptor Inhibitor 18 (FACT-EGFRi-18) at Week 8 | ||||||||||||
End point description |
The FACT-EGFRi-18 was an 18-item likert-scaled questionnaire, arranged in three dimensions: physical (seven items),
social/emotional (six items), and functional well-being (five items). The response scores ranged from 0 (not at all) to 4
(very much).
The total score was obtained by multiplying the sum of the subscale by the number of items in the scale (18), and then
dividing by the number of items actually answered.
The total score ranged from 0-72 with a higher score represented a high level of symptomatology (problems).
Due to early study termination, no participant was evaluated in the imsidolimab group and 1 participant was evaluated in the placebo group. Since only 1 participant was evaluated, results were not reported for the protection of personal data and to avoid re-identification.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 8
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| Notes [26] - Due to early study termination, no participant was evaluated. [27] - Only 1 participant was evaluated. Results were not reported for the protection of personal data. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Participants With Treatment-Emergent Adverse Events | |||||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to study treatment. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with use of study treatment that did not necessarily have a causal relationship with this treatment. An AE was considered "serious" if there was any of the following outcomes: death, life-threatening, Inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, congenital anomaly/birth defect, other important medical events. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
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End point type |
Secondary
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End point timeframe |
From first dose to 55 days
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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 |
From first dose to 55 days
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Adverse event reporting additional description |
Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo.
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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 |
24.1
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Reporting groups
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Reporting group title |
Imsidolimab
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Reporting group description |
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | |||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by subcutaneous injection. | |||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||
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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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11 Feb 2021 |
This amendment was prepared to address the following issues:
1) Permit small editorial changes for correctness.
2) Clarify modifications to MESTT, use of CTCAE scoring and corresponding statistical analysis.
3) Permit (optional) home health visits during the COVID-19 pandemic, describe home nursing visit procedures, and acknowledge that COVID-19 measures only apply if they are in accordance with current, locally-applicable recommendations/regulations.
4) Permit the use of remaining serum from samples collected for PK/immunogenicity endpoints to be retained for assay method development, troubleshooting, or validation.
5) Clarify timing for administration of live attenuated vaccines after the participant completes the 12-week standard safety follow-up period of the study or after 12 weeks following the last administration of the study drug for participant who discontinued from the study early.
6) Clarify timing requirements for use of hormonal contraceptives prior to and during study participation and to identify which oral hormonal contraceptives are permissible.
7) Permit enrolment of participants treated with any commercially-available EGFRi or MEKi therapy.
8) Include a 30-minute observation period of study participants after application of each dose of imsidolimab to identify any potential allergic/anaphylactic reaction. 9) Clarify timing of anti-drug antibody sample collection. |
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05 Aug 2021 |
This amendment was prepared to address the following issues:
1) Permit small editorial changes for clarity and correctness.
2) Update the name of the Sponsor medical expert and signatory, and address of the Sponsor.
3) Allow inclusion of participants with benign neoplasm (not cancer).
4) Revised eligibility criteria for body weight to ≥40kg.
5) Updated tuberculosis screening as inclusion criteria.
6) Clarified definition of childbearing potential in contraceptive use exclusion criteria.
7) Allow screening of participants prior to rash onset.
8) Reduce the number of study visits by removing Week 1 and Week 6 visits.
9) Modify the list of study endpoints by removing percent change from baseline from some endpoints and revised exploratory endpoints based on planned data collection.
10) Clarify the recommended order of assessments to be followed during the study visits.
11) Add an evaluation of the Fitzpatrick Skin Type Classification.
12) Reduce the number of electrocardiograms (ECGs) to be performed during the study.
13) Reduce the number of tape strip samples to be collected and clarify the location for sample collection.
14) Reduce the number of blood samples to be collected for pharmacokinetic (PK) evaluations.
15) Removal of noncompartmental analysis (NCA) due to limited PK sampling.
16) Update washout periods for prohibited treatments.
17) Add clarification related to vaccines allowed during the study.
18) Clarify if a participant were to discontinue early from the study, an early termination visit will be required.
19) Remove the possibility of participants’ replacement.
20) Clarify assessment of facial lesions.
21) Remove facsimile as an option to report serious adverse events (SAEs).
22) Update the text to indicate local laboratory tests will be allowed at Screening for tuberculosis and viral serology testing |
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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 | |||
