Trial Outcomes & Findings for Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV) (NCT NCT04525157)
NCT ID: NCT04525157
Last Updated: 2023-09-22
Results Overview
A decrease in VASI over time indicates a reduction of the body surface area affected by vitiligo and/ or a reduction in the body sites' degree of depigmentation (possible range 1-100)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
From Day 0 to Day 196
Results posted on
2023-09-22
Participant Flow
18 participants were enrolled in the Arm Afamelanotide and NB-UVB (pooled analysis)
Participant milestones
| Measure |
Afamelanotide and NB-UVB (Pooled Analysis)
The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.
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|---|---|
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Overall Study
STARTED
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18
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Overall Study
COMPLETED
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15
|
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Overall Study
NOT COMPLETED
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3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)
Baseline characteristics by cohort
| Measure |
Afamelanotide and NB-UVB (Pooled Analysis)
n=18 Participants
The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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18 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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14 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From Day 0 to Day 196A decrease in VASI over time indicates a reduction of the body surface area affected by vitiligo and/ or a reduction in the body sites' degree of depigmentation (possible range 1-100)
Outcome measures
| Measure |
Afamelanotide and NB-UVB (Pooled Analysis)
n=15 Participants
The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.
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|---|---|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Total Day 28
|
0.00 Change in VASI score from baseline
Interval -0.63 to 0.25
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Head and Neck Day 28
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0.00 Change in VASI score from baseline
Interval -0.63 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Hands Day 28
|
0.00 Change in VASI score from baseline
Interval 0.0 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Upper Extremities Day 28
|
0.00 Change in VASI score from baseline
Interval 0.0 to 0.25
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Trunk Day 28
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0.00 Change in VASI score from baseline
Interval 0.0 to 0.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Lower Extremities Day 28
|
0.00 Change in VASI score from baseline
Interval 0.0 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Feet Day 28
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0.00 Change in VASI score from baseline
Interval 0.0 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Total Day 56
|
-0.05 Change in VASI score from baseline
Interval -2.25 to 1.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Head and Neck Day 56
|
0.00 Change in VASI score from baseline
Interval -0.88 to 1.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Hands Day 56
|
0.00 Change in VASI score from baseline
Interval -0.25 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Upper Extremities Day 56
|
0.00 Change in VASI score from baseline
Interval -1.5 to 0.25
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Trunk Day 56
|
0.00 Change in VASI score from baseline
Interval -1.0 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Lower Extremities Day 56
|
0.00 Change in VASI score from baseline
Interval -2.25 to 0.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Feet Day 56
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0.00 Change in VASI score from baseline
Interval -0.2 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Total Day 84
|
-0.70 Change in VASI score from baseline
Interval -12.38 to 0.25
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Head and neck Day 84
|
0.00 Change in VASI score from baseline
Interval -0.88 to 1.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Hands Day 84
|
0.00 Change in VASI score from baseline
Interval -0.5 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Upper Extremities Day 84
|
0.00 Change in VASI score from baseline
Interval -1.5 to 0.25
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Trunk Day 84
|
0.00 Change in VASI score from baseline
Interval -7.75 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Lower Extremities Day 84
|
0.00 Change in VASI score from baseline
Interval -4.5 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Feet Day 84
|
0.00 Change in VASI score from baseline
Interval -0.2 to 0.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Total Day 112
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-1.13 Change in VASI score from baseline
Interval -12.38 to 0.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Head and Neck Day 112
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-0.10 Change in VASI score from baseline
Interval -1.0 to 0.5
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Hands Day 112
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0.00 Change in VASI score from baseline
Interval -0.5 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Upper Extremities Day 112
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0.00 Change in VASI score from baseline
Interval -3.0 to 0.25
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Trunk Day 112
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-0.13 Change in VASI score from baseline
Interval -7.75 to 0.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Lower Extremities Day 112
|
0.00 Change in VASI score from baseline
Interval -4.5 to 0.38
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|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Feet Day 112
|
0.00 Change in VASI score from baseline
Interval -0.5 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Total Day 140
|
-2.56 Change in VASI score from baseline
Interval -15.15 to 0.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Head and Neck Day 140
|
-0.11 Change in VASI score from baseline
Interval -1.0 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Hands Day 140
|
0.00 Change in VASI score from baseline
Interval -1.0 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Upper Extremities Day 140
|
-0.50 Change in VASI score from baseline
Interval -6.0 to 0.13
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Trunk Day 140
|
-0.50 Change in VASI score from baseline
Interval -7.75 to 0.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Lower Extremities Day 140
|
-0.50 Change in VASI score from baseline
Interval -5.85 to 0.38
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Feet Day 140
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0.00 Change in VASI score from baseline
Interval -0.5 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Total Day 168
|
-2.86 Change in VASI score from baseline
Interval -15.15 to 0.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Head and Neck Day 168
|
-0.13 Change in VASI score from baseline
Interval -1.0 to 0.0
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Hands Day 168
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0.00 Change in VASI score from baseline
Interval -1.0 to 0.0
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|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Upper Extremities Day 168
|
-0.50 Change in VASI score from baseline
Interval -6.0 to 1.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Trunk Day 168
|
-1.00 Change in VASI score from baseline
Interval -7.75 to 0.0
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|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Lower Extremities Day 168
|
-0.75 Change in VASI score from baseline
Interval -5.85 to 0.38
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Feet Day 168
|
0.00 Change in VASI score from baseline
Interval -0.5 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Total Day 196
|
-3.70 Change in VASI score from baseline
Interval -15.65 to 1.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Head and Neck Day 196
|
-0.13 Change in VASI score from baseline
Interval -1.0 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Hands Day 196
|
0.00 Change in VASI score from baseline
Interval -1.0 to 0.0
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Upper Extremities Day 196
|
-1.00 Change in VASI score from baseline
Interval -6.0 to 1.0
|
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Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Trunk Day 196
|
-1.13 Change in VASI score from baseline
Interval -7.75 to 0.75
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Lower Extremities Day 196
|
-0.60 Change in VASI score from baseline
Interval -5.85 to 0.38
|
|
Change in Pigmentation (Total and Individual Body Parts) Using the Vitiligo Area Scoring Index (VASI)
Feet Day 196
|
0.00 Change in VASI score from baseline
Interval -0.5 to 0.0
|
Adverse Events
Afamelanotide and NB-UVB (Pooled Analysis)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Afamelanotide and NB-UVB (Pooled Analysis)
n=18 participants at risk
The study design was modified from a randomised controlled (Afamelanotide plus NB-UVB versus placebo plus NB-UVB) to an open label study (afamelanotide plus NB-UVB). A pooled analysis of all patients who received afamelanotide plus NB-UVB was undertaken and the results are presented.
|
|---|---|
|
General disorders
Fatigue
|
5.6%
1/18
|
|
Investigations
Glomerular filtration rate decreased
|
5.6%
1/18
|
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Investigations
Urinary casts
|
5.6%
1/18
|
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Nervous system disorders
Lethargy
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5.6%
1/18
|
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Skin and subcutaneous tissue disorders
Nail pigmentation
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11.1%
2/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place