Trial Outcomes & Findings for Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis (NCT NCT04305327)

Results Overview

PASI 75 response is defined as having at least 75% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, were assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions was also assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

12 participants

Primary outcome timeframe

Baseline to Week 12

Results posted on

2025-03-14

Participant Flow

Participants were recruited across countries in Europe (Belgium, Germany, Hungary, Italy, Poland, Spain) from December 2022 to May 2023 when the study was early terminated.

In the 12 weeks Induction Period (Week 0 to Week 12) participants were assigned to brodalumab, ustekinumab or placebo. This was followed by a Maintenance Period of 40 weeks (Week 12 to Week 52) where those receiving ustekinumab or brodalumab continued with the same medication whereas participants on placebo were switched to either brodalumab or ustekinumab.

Participant milestones

Participant milestones
Measure	Brodalumab Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52.	Ustekinumab Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing \>100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52.	Placebo/Brodalumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to \<70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo.	Placebo/Ustekinumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to \<60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed \>100 kg received 90 mg ustekinumab.
Overall Study STARTED	2	6	2	2
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	2	6	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Brodalumab Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52.	Ustekinumab Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing \>100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52.	Placebo/Brodalumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to \<70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo.	Placebo/Ustekinumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to \<60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed \>100 kg received 90 mg ustekinumab.
Overall Study Study early termination	2	5	2	2
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the full analysis set (FAS) which includes all randomized participants.

PASI 75 response is defined as having at least 75% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, were assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions was also assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.

Outcome measures

Outcome measures
Measure	Ustekinumab Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing \>100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52.	Placebo/Brodalumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to \<70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo.	Placebo/Ustekinumab n=1 Participants Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to \<60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed \>100 kg received 90 mg ustekinumab.	Brodalumab n=1 Participants Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52.
Psoriasis Area and Severity Index (PASI) 75 Response, Assessed at Week 12.	—	—	NA Participants Due to early termination, only 2 participants completed Week 12 and therefore, no data is reported to maintain participant confidentiality.	NA Participants Due to early termination, only 2 participants completed Week 12 and therefore, no data is reported to maintain participant confidentiality.

SECONDARY outcome

Timeframe: Week 12

Population: Due to early termination, data was not collected

The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12

Population: Due to early termination, data was not collected

The sPGA is an instrument used in clinical trials to rate the severity of the participant's global psoriasis and is based on a 6-point scale ranging from 0 (clear) to 5 (very severe). The number of participants achieving a score of 0 (clear) or 1 (almost clear) was assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the FAS which includes all randomized participants.

PASI 90 response is defined as having at least 90% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.

Outcome measures

Outcome measures
Measure	Ustekinumab Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing \>100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52.	Placebo/Brodalumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to \<70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo.	Placebo/Ustekinumab n=1 Participants Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to \<60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed \>100 kg received 90 mg ustekinumab.	Brodalumab n=1 Participants Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52.
PASI 90 Response, Assessed at Week 12.	—	—	NA Participants Due to early termination, only 2 participants completed Week 12 and therefore, no data is reported to maintain participant confidentiality.	NA Participants Due to early termination, only 2 participants completed Week 12 and therefore, no data is reported to maintain participant confidentiality.

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: Participants who completed at Week 12 are included in the overall number of participants analysed. Dataset from the FAS which includes all randomized participants.

PASI 100 response is defined as having at least 100% improvement in PASI score from baseline. The severity of 3 psoriasis disease characteristics (redness, thickness, and scaliness) on each of the 4 body regions, head/neck, trunk, upper extremities, and lower extremities, will be assessed according to a severity scale. The extent of psoriasis within each of the 4 body regions will also be assessed. This gives a composite score ranging from 0 to 72, with higher values indicating a more severe and/or more extensive condition.

Outcome measures

Outcome measures
Measure	Ustekinumab Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing \>100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52.	Placebo/Brodalumab Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to \<70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo.	Placebo/Ustekinumab n=1 Participants Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to \<60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed \>100 kg received 90 mg ustekinumab.	Brodalumab n=1 Participants Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52.
PASI 100 Response, Assessed at Week 12.	—	—	NA Participants Due to early termination, only 2 participants completed Week 12 and therefore, no data is reported to maintain participant confidentiality.	NA Participants Due to early termination, only 2 participants completed Week 12 and therefore, no data is reported to maintain participant confidentiality.

SECONDARY outcome

Timeframe: Week 12

Population: Due to early termination, data was not collected

CDLQI consists of 10 items addressing the child's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12

Population: Due to early termination, data was not collected

FDLQI consists of 10 items addressing the participant's relative perception of the impact of the participant's skin disease on various aspects of his/her quality of life over the last month such as: emotional distress, social life, job and leisure activities, physical well-being, time spent on helping the subject with e.g., treatment procedures, extra housework, and routine household expenditure. Each item is scored on a 4-point scale ranging from 0 (not at all) to 3 (very much). The total score is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 5 months

Population: Dataset from the safety analysis set (SAS) which includes all participants who received at least 1 dose of IMP.

An AE is defined as any untoward medical occurrence in subjects or clinical investigation participants administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.

Outcome measures

Outcome measures
Measure	Ustekinumab n=6 Participants Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing \>100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52.	Placebo/Brodalumab n=2 Participants Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to \<70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo.	Placebo/Ustekinumab n=2 Participants Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to \<60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed \>100 kg received 90 mg ustekinumab.	Brodalumab n=2 Participants Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52.
Overall Number of Adverse Events (AEs) Any AEs related to IMP	3 Adverse events	0 Adverse events	0 Adverse events	0 Adverse events
Overall Number of Adverse Events (AEs) Any AEs	5 Adverse events	0 Adverse events	3 Adverse events	4 Adverse events

SECONDARY outcome

Timeframe: Week 4, Week 16, and Week 52

Population: Due to early termination, data was not collected

Number of participants with a positive post-baseline anti-drug antibody result at weeks 4, 16, and 52.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 8, Week 12, and Week 52

Population: Due to early termination, data was not collected

Number of participants with detectable levels of Interleukin-17 at weeks 8, 12, and 52.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 8, Week 12, and Week 52

Population: Due to early termination, data was not collected

Number of participants with detectable levels of T-cell subsets at weeks 8, 12, and 52.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 10, Week 12, Week 16, Week 22, and Week 52

Population: Due to early termination, data was not collected

Number of participants with detectable levels of brodalumab at weeks 4, 8, 10, 12, 16, 22, and 52.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 12

Population: Due to early termination, data was not collected

Number of participants with detectable levels of anti-tetanus toxoid antibodies at weeks 12.

Outcome measures

Outcome data not reported

Adverse Events

Brodalumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Ustekinumab

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo/Brodalumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo/Ustekinumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Brodalumab n=2 participants at risk Participants were randomised to receive brodalumab subcutaneously (SC) at Weeks 0, 1, 2, and then every 2 weeks until week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<70 kg received 140 mg brodalumab, participants weighing ≥70 kg received 210 mg brodalumab. Participants randomised at Week 0 to brodalumab would have continued with the allocated treatment until Week 52.	Ustekinumab n=6 participants at risk Participants were randomised to receive ustekinumab SC at Week 0 and 4, and then every 12 weeks until Week 50. The dose was determined by the participant's body weight. Participants weighing 30 to \<60 kg received 0.75 mg ustekinumab per kg body weight. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighing \>100 kg received 90 mg ustekinumab. Participants randomised at Week 0 to ustekinumab would have continued with the allocated treatment until Week 52.	Placebo/Brodalumab n=2 participants at risk Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received brodalumab at Weeks 12, 13, 14, and every 2 weeks thereafter, with the last brodalumab dose administered at Week 50. The doses were body weight-dependent, participants weighing 30 to \<70 kg received 140 mg brodalumab or 1.0 mL placebo. Participants weighing ≥70 kg received 210 mg brodalumab or 1.5 mL placebo.	Placebo/Ustekinumab n=2 participants at risk Participants were randomised to receive placebo at Weeks 0, 1, 2, 4, 6, 8, and 10. Following the initial 12 Weeks of placebo, participants received ustekimumab at Weeks 12, 16, 28, and 40. Doses of ustekimumab were body weight-dependent, participants weighing 30 to \<60 kg received 0.75 mg/kg. Participants weighing ≥60 and ≤100 kg received 45 mg ustekinumab, and those weighed \>100 kg received 90 mg ustekinumab.
Infections and infestations Nasopharyngitis	50.0% 1/2 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	33.3% 2/6 • Number of events 2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Infections and infestations Gastroenteritis	50.0% 1/2 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/6 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Infections and infestations Rhinitis	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/6 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	50.0% 1/2 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Infections and infestations Tonsillitis	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/6 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	50.0% 1/2 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	16.7% 1/6 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
General disorders Pyrexia	50.0% 1/2 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/6 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Investigations Depression rating scale score increased	50.0% 1/2 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/6 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Nervous system disorders Dizziness	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	16.7% 1/6 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Psychiatric disorders Depression	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/6 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	50.0% 1/2 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	16.7% 1/6 • Number of events 1 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.	0.00% 0/2 • Up to approximately 5 months Data from the safety analysis set, all participants received at least 1 dose of the investigational medicinal product.

Additional Information

Clinical disclosure

LEO Pharma A/S

Phone: +45 4494 5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma A/S seeks publication of all clinical trials in peer-reviewed journals within 18 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by LEO Pharma A/S within these 18 months, the investigator has the right to publish the results from the clinical trial generated by him/herself.
Publication restrictions are in place

Restriction type: OTHER