Clinical Trial Results:
A 28-week, randomized, double-blind, active-controlled, multicenter study to evaluate the efficacy of subcutaneously administered secukinumab compared to ustekinumab in adult patients with psoriatic arthritis and failure of TNFα-inhibitor treatment (AgAIN)
|
Summary
|
|
EudraCT number |
2019-004246-15 |
Trial protocol |
DE |
Global end of trial date |
22 Oct 2024
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
23 Oct 2025
|
First version publication date |
23 Oct 2025
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
CAIN457FDE04
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT04632927 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Novartis Pharma AG
|
||
Sponsor organisation address |
Novartis Campus, Basel, Switzerland,
|
||
Public contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@Novartis.com
|
||
Scientific contact |
Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@Novartis.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
22 Oct 2024
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
22 Oct 2024
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
The primary objective was to demonstrate that secukinumab 300 mg subcutaneously (s.c.) is superior to ustekinumab 45/90 mg s.c. at Week 28 with regard to the proportion of patients achieving an improvement in score of ≥0.35 score points vs. Baseline (referred to as HAQ-DI response).
|
||
Protection of trial subjects |
The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Dec 2020
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Germany: 119
|
||
Worldwide total number of subjects |
119
|
||
EEA total number of subjects |
119
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
101
|
||
From 65 to 84 years |
18
|
||
85 years and over |
0
|
||
|
||||||||||||||||||||||||||||||||||
|
Recruitment
|
||||||||||||||||||||||||||||||||||
Recruitment details |
Patients were randomized in 28 study sites across Germany | |||||||||||||||||||||||||||||||||
|
Pre-assignment
|
||||||||||||||||||||||||||||||||||
Screening details |
A total of 144 patients overall were screened and 25 patients failed screening, while 119 patients completed the screening period successfully and underwent randomization | |||||||||||||||||||||||||||||||||
|
Period 1
|
||||||||||||||||||||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
|||||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
|||||||||||||||||||||||||||||||||
Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Data analyst, Assessor | |||||||||||||||||||||||||||||||||
|
Arms
|
||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
|||||||||||||||||||||||||||||||||
|
Arm title
|
Secukinumab | |||||||||||||||||||||||||||||||||
Arm description |
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24. | |||||||||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Secukinumab
|
|||||||||||||||||||||||||||||||||
Investigational medicinal product code |
AIN457
|
|||||||||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Solution for injection in pre-filled syringe
|
|||||||||||||||||||||||||||||||||
Routes of administration |
Subcutaneous use
|
|||||||||||||||||||||||||||||||||
Dosage and administration details |
Secukinumab for subcutaneous injection was provided in a pre-filled syringe (PFS) containing 150 mg. Each 300 mg dose was administered as two separate subcutaneous injections of 150 mg each
|
|||||||||||||||||||||||||||||||||
|
Arm title
|
Ustekinumab | |||||||||||||||||||||||||||||||||
Arm description |
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants >100 kg). One active injection was administered at Baseline, Week 4, and 16. To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point. | |||||||||||||||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
|
|||||||||||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Solution for injection in pre-filled syringe
|
|||||||||||||||||||||||||||||||||
Routes of administration |
Subcutaneous use
|
|||||||||||||||||||||||||||||||||
Dosage and administration details |
Placebo was provided in a matching PFS.
|
|||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Ustekinumab
|
|||||||||||||||||||||||||||||||||
Investigational medicinal product code |
||||||||||||||||||||||||||||||||||
Other name |
||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Solution for injection in pre-filled syringe
|
|||||||||||||||||||||||||||||||||
Routes of administration |
Subcutaneous use
|
|||||||||||||||||||||||||||||||||
Dosage and administration details |
Ustekinumab was provided in a PFS containing either 45 mg or 90 mg for subcutaneous injection. According to the label, patients weighing ≤ 100 kg at baseline received a 45 mg dose, while those weighing > 100 kg received 90 mg.
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Secukinumab
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Ustekinumab
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants >100 kg). One active injection was administered at Baseline, Week 4, and 16. To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Secukinumab
|
||
Reporting group description |
Participants received 300 mg of secukinumab, administered as two 150 mg subcutaneous (s.c.) injections. Treatment was administered in a double-blind manner at Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24. | ||
Reporting group title |
Ustekinumab
|
||
Reporting group description |
Participants received ustekinumab via s.c. injection containing 45 mg (for participants weighing ≤100 kg) or 90 mg (for participants >100 kg). One active injection was administered at Baseline, Week 4, and 16. To maintain the blind, secukinumab-matching placebo injections were administered at all treatment time points (Baseline and at Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24). Depending on whether an ustekinumab injection was scheduled, participants received either one or two placebo injections per time point. | ||
|
||||||||||
End point title |
Proportion of patients with Health assessment questionnaire – disability index (HAQ-DI) response at Week 28 | |||||||||
End point description |
The disability assessment component of the HAQ evaluated a subject’s level of functional ability through 20 questions grouped into 8 categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item began with the prompt “Over the past week, are you able to…” and is scored on a 4-point scale: 0 (no difficulty), 1 (some difficulty), 2 (much difficulty), and 3 (unable to do). The overall score was calculated by averaging the scores across all answered domains, resulting in a total score ranging from 0 (no disability) to 3 (severe disability).
A HAQ-DI response was defined as an improvement of ≥0.35 points from baseline at Week 28. Missing values were imputed as non-responders
|
|||||||||
End point type |
Primary
|
|||||||||
End point timeframe |
Baseline, Week 28
|
|||||||||
|
||||||||||
Statistical analysis title |
Secukinumab vs Ustekinumab | |||||||||
Comparison groups |
Secukinumab v Ustekinumab
|
|||||||||
Number of subjects included in analysis |
119
|
|||||||||
Analysis specification |
Pre-specified
|
|||||||||
Analysis type |
superiority | |||||||||
P-value |
= 0.002 | |||||||||
Method |
Regression, Logistic | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
3.647
|
|||||||||
Confidence interval |
||||||||||
level |
95% | |||||||||
sides |
2-sided
|
|||||||||
lower limit |
1.601 | |||||||||
upper limit |
8.311 | |||||||||
|
||||||||||
End point title |
Number of participants achieving Psoriasis area and severity index (PASI) 90 response at Week 28 | |||||||||
End point description |
The Psoriasis Area and Severity Index (PASI) was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions—each graded on a scale from 0 (none) to 4 (severe)—across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity.
The number of participants who achieved at least a 90% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline, Week 28
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||||||||
End point title |
Change from baseline in Patient’s assessment of pain on VAS at Week 28 | ||||||||||||
End point description |
The patient's level of pain was evaluated using a horizontal Visual Analogue Scale (VAS), on which individuals marked their pain intensity with a vertical tick. The scale ranged from 0 mm (indicating "no pain") to 100 mm (indicating "unbearable pain").
The change in the patient’s pain assessment on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change from baseline in Swollen Joint Count (SJC) 66 at Week 28 | ||||||||||||
End point description |
Swollen Joint Count (SJC) 66 was a method of assessing joint inflammation. The number of swollen joints was determined by examining 66 joints and identifying those with visible or palpable swelling suggestive of synovitis. The 66 joints assessed for swelling included the 2 sternoclavicular, 2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, 2 knees, 2 talotibial, 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet.
The change from baseline in SJC66 at Week 28 was assessed. A negative change from baseline indicated improvement.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change from baseline in Patient’s Global Assessment of Disease Activity on VAS | ||||||||||||
End point description |
The patient’s global assessment of disease activity was performed using a 100 mm (VAS) ranging from 0 (=‘very good’) to 100 (=‘very poor’) after the question ‘Considering all the ways Psoriatic Arthritis affects you, please indicate with a vertical mark through the horizontal line how well you are today’.
The change in the patient’s global assessment on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||
End point title |
Number of patients achieving PASI 75 at Week 28 | |||||||||
End point description |
The Psoriasis Area and Severity Index (PASI) was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions—each graded on a scale from 0 (none) to 4 (severe)—across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity.
The number of participants who achieved at least a 75% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline, Week 28
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
Number of patients achieving PASI 100 at Week 28 | |||||||||
End point description |
The PASI was a composite measure that evaluates the average severity of erythema, induration, and desquamation of psoriatic lesions—each graded on a scale from 0 (none) to 4 (severe)—across four body regions: head, upper limbs, trunk (including groin), and lower limbs (to the top of the buttocks). These scores were weighted by the area of skin involvement in each region to generate a total PASI score ranging from 0 to 72, with higher scores indicating more severe disease activity.
The number of participants who achieved 100% reduction in PASI score from baseline at Week 28 was assessed. Missing values were imputed as non-responders.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Bseline, Week 28
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||||||||
End point title |
Change from baseline in Tender Joint Count (TJC) 68 at Week 28 | ||||||||||||
End point description |
Tender joint count (TJC) 68 was a method of assessing joint inflammation. Number of tender joints was determined by examining 68 joints and identifying the joints that were painful under pressure or to passive motion. The 68 joints assessed for tenderness included the 2 temporomandibular, 2 sternoclavicular, 2 acromioclavicular joints, 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal, 10 proximal interphalangeal, 8 distal interphalangeal joints of the hands, 2 hips, 2 knees, 2 talo¬tibial, 2 mid-tarsal, 10 metatarsophalangeal, and 10 proximal interphalangeal joints of the feet.
The change from baseline in TJC68 at Week 28 was assessed. A negative change from baseline indicated improvement.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change from baseline in the Leeds Dactylitis Index (LDI) | ||||||||||||
End point description |
The LDI was used to quantitatively assess dactylitis by measuring the circumference of affected digits and their corresponding control digits, along with the tenderness of each affected digit. Digits were classified as dactylitic if there was a ≥10% difference in circumference compared to the contralateral digit. When both digits were affected or a contralateral control was unavailable, a standardized reference range was applied.
For each dactylitic digit, the ratio of the affected to control circumference was multiplied by a binary tenderness score (1 = tender, 0 = non-tender). The resulting values were summed across all affected digits to calculate the total LDI score. A higher LDI score indicated more severe or widespread dactylitis.
The change in the LDI score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in dactylitis severity.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||
End point title |
Number of patients achieving Minimal Disease Activity (MDA) at Week 28 | |||||||||
End point description |
MDA was a composite endpoint used to assess low disease activity in patients with psoriatic arthritis and psoriasis. A patient was considered to have achieved MDA if they met at least 5 of the following 7 criteria:
- TJC68 ≤ 1
- SJC66 ≤ 1
- PASI ≤1 [the total score ranged from 0 (no disease) to 72 (maximal disease)] or body surface area≤3%
- Patient’s pain VAS ≤ 15 mm on a 100 mm scale, where 0 ="no pain" and 100= "pain as severe as can be imagined"
- Patient’s global assessment of disease activity (PtGA) ≤ 20 mm on a 100 mm scale, where 0 represented the lowest level of disease activity and 100 the highest
- HAQ-DI ≤ 0.5, where 0 represented no difficulty and 3 represented inability to perform activities
- Enthesitis count ≤ 1, based on the Leeds Enthesitis Index, where 0 indicated no tenderness and 6 indicated tenderness at all assessed tendon insertions
The number of participants achieving MDA at Week 28 was assessed. Missing values were imputed as non-responders.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Week 28
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||||||||
End point title |
Change from baseline in the Leeds Enthesitis Index (LEI) | ||||||||||||
End point description |
The LEI was a validated enthesitis index that used six sites to evaluate enthesitis: the left and right lateral epicondyles of the humerus, the left and right proximal Achilles tendon insertions, and the left and right medial femoral condyles.Each site was scored as 0 (non-tender) or 1 (tender), resulting in a total score ranging from 0 to 6. A higher score reflected a greater burden of enthesitis.
The change in the LEI score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in enthesitis severity
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change from baseline in Patient’s Global Assessment of Psoriasis and Arthritis Disease Activity on VAS | ||||||||||||
End point description |
The patient’s assessment of psoriasis and arthritis was performed using a 100 mm VAS ranging from 0 (=’Excellent’) to 100 (=’Poor’) after the question ’Considering all the ways PSORIASIS and ARTHRITIS affects you, please indicate with a vertical mark through the horizontal line how well you are doing over the past week’
The change in the patient’s global assessment of psoriasis and arthritis disease activity on the VAS from baseline to Week 28 was analyzed. A negative change from baseline indicated improvement.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||
End point title |
Change from baseline in Psoriatic Arthritis Quality of Life (PsAQoL) | ||||||||||||
End point description |
The PsAQoL questionnaire was used to assess the impact of psoriatic arthritis on patients’ quality of life. The PsAQoL is a validated, disease-specific, self-administered instrument consisting of 20 items with binary response options (“true” or “not true”). Items covered physical, emotional, and social domains, including fatigue, independence, and interpersonal relationships. The total score ranged from 0 to 20, with higher scores indicating greater impairment in quality of life.
The change in the PsAQoL score from baseline to Week 28 was analyzed. A negative change from baseline indicated an improvement in health-related quality of life.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline, Week 28
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
||||||||||
End point title |
Percentage of participants achieving a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) response at Week 28 | |||||||||
End point description |
The FACIT-Fatigue Scale was used to assess fatigue and its impact on daily functioning over the previous 7 days. The instrument consisted of 13 self-administered items, each scored on a 5-point Likert scale ranging from 0 (“Not at all”) to 4 (“Very much”). The total score ranged from 0 to 52, with higher scores indicating less fatigue and better functioning.
Response was achieved if the score had improved by at least 4 points from baseline. Missing values were imputed as non-responders
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Baseline, Week 28
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
||||||||||
End point title |
Percentage of participants achieving a Dermatology Life Quality Index (DLQI) response at Week 28 | |||||||||
End point description |
The DLQI was used to evaluate the impact of dermatological conditions on patients’ quality of life over the previous 7 days. It consisted of 10 self-administered items covering symptoms, daily activities, leisure, work/school, personal relationships, and treatment burden. Each item was scored from 0 (“Not at all”) to 3 (“Very much”), with a total score ranging from 0 to 30. Higher scores indicated greater impairment.
Response was achieved if the absolute score was either 0 or 1. Missing values were imputed as non-responders.
|
|||||||||
End point type |
Secondary
|
|||||||||
End point timeframe |
Week 28
|
|||||||||
|
||||||||||
| No statistical analyses for this end point | ||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From start of treatment to end of study, assessed up to approximately 36 weeks
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
The safety analysis were done on the safety population, which included all randomized subjects who received at least one dose of study medication.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
27.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
On-Treatment SEC 300 mg s.c.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
On-Treatment SEC 300 mg s.c. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
On-Treatment UST 45/90 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
On-Treatment UST 45/90 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Entire study SEC 300 mg s.c.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Entire study SEC 300 mg s.c. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Entire study UST 45/90 mg
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Entire study UST 45/90 mg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
10 Sep 2024 |
Changes due to early termination of recruitment:
• Update/removal of some exploratory endpoints
• Specification that analyses will only be descriptive
Changes to accommodate current requirements regarding patient safety:
• Update of AE safety follow-up to align with SAE safety follow-up
• SAE reporting: Inclusion of Hy’s law language
• Update of reporting requirements for study treatment errors including misuse/abuse |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
