Trial Outcomes & Findings for Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE) (NCT NCT04704713)
NCT ID: NCT04704713
Last Updated: 2021-03-19
Results Overview
PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
From Day 0 to Day 120
Results posted on
2021-03-19
Participant Flow
Participant milestones
| Measure |
Afamelanotide
Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Afamelanotide
|
Placebo
Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
Baseline characteristics by cohort
| Measure |
Afamelanotide
n=15 Participants
Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Afamelanotide
|
Placebo
n=16 Participants
Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Placebo
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Day 0 to Day 120PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus).
Outcome measures
| Measure |
Afamelanotide
n=15 Participants
Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Afamelanotide
|
Placebo
n=16 Participants
Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Placebo
|
|---|---|---|
|
Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale
|
0.25 score on a scale
Interval 0.0 to 1.4
|
0.47 score on a scale
Interval 0.0 to 4.1
|
SECONDARY outcome
Timeframe: From Day 0 to Day 120Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Day 0 to Day 120Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Day 0, Day 60 and Day 120The DLQI questionnaire consists of 10 questions, each answered on a categorical scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Outcome measures
Outcome data not reported
Adverse Events
Afamelanotide
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Afamelanotide
n=15 participants at risk
Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Afamelanotide
|
Placebo
n=16 participants at risk
Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Placebo
|
|---|---|---|
|
Nervous system disorders
dizziness
|
6.7%
1/15
|
0.00%
0/16
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
26.7%
4/15
|
18.8%
3/16
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15
|
12.5%
2/16
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
6.7%
1/15
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
20.0%
3/15
|
0.00%
0/16
|
|
General disorders
Device expulsion
|
0.00%
0/15
|
6.2%
1/16
|
|
General disorders
Fatigue
|
13.3%
2/15
|
0.00%
0/16
|
|
Vascular disorders
Hypertension
|
6.7%
1/15
|
6.2%
1/16
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
6.7%
1/15
|
6.2%
1/16
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
3/15
|
18.8%
3/16
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15
|
12.5%
2/16
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/15
|
6.2%
1/16
|
|
Infections and infestations
Influenza
|
6.7%
1/15
|
0.00%
0/16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place