Trial Outcomes & Findings for Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS) (NCT NCT04572997)
NCT ID: NCT04572997
Last Updated: 2021-09-24
Results Overview
The PPPASI assess palms of hands and soles of feet for psoriasis involvement. The PPPASI score range from 0-72, with higher scores indicating more severe disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
PPPASI Score at baseline and Week 20.
Results posted on
2021-09-24
Participant Flow
Participant milestones
| Measure |
Full Analysis Set (FAS)
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
Apremilast was taken orally twice daily (except Day 1). During the first 5 days, the dosage was up-titrated. The initial dose on day 1 was 10 mg in the morning; this was increased to 10 mg in the morning and evening on day 2. The evening dose was further increased by 10 mg (to 20 mg) on day 3. On day 4, the morning dose was increased to 20 mg, so that 20 mg was taken twice daily, and on day 5 the evening dose was increased to 30 mg. From Day 6 onwards, patients received the 30 mg dose twice a day.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Full Analysis Set (FAS)
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
Apremilast was taken orally twice daily (except Day 1). During the first 5 days, the dosage was up-titrated. The initial dose on day 1 was 10 mg in the morning; this was increased to 10 mg in the morning and evening on day 2. The evening dose was further increased by 10 mg (to 20 mg) on day 3. On day 4, the morning dose was increased to 20 mg, so that 20 mg was taken twice daily, and on day 5 the evening dose was increased to 30 mg. From Day 6 onwards, patients received the 30 mg dose twice a day.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Apremilast in Patients With Moderate to Severe Palmoplantar Pustulosis (PPP) (APLANTUS)
Baseline characteristics by cohort
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
|---|---|
|
Age, Continuous
|
59.76 years
STANDARD_DEVIATION 9.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other (Sinti)
|
1 Participants
n=5 Participants
|
|
Highest educational status
University degree
|
2 Participants
n=5 Participants
|
|
Highest educational status
Professional School
|
5 Participants
n=5 Participants
|
|
Highest educational status
Secondary school leaving certificate
|
14 Participants
n=5 Participants
|
|
Is the patient a smoker?
Non-smoker
|
2 Participants
n=5 Participants
|
|
Is the patient a smoker?
Ex-smoker
|
4 Participants
n=5 Participants
|
|
Is the patient a smoker?
Current smoker
|
15 Participants
n=5 Participants
|
|
Current involvement of scalp
No
|
20 Participants
n=5 Participants
|
|
Current involvement of scalp
Yes
|
1 Participants
n=5 Participants
|
|
Current involvement of nails
No
|
11 Participants
n=5 Participants
|
|
Current involvement of nails
Yes
|
9 Participants
n=5 Participants
|
|
Current involvement of nails
Unknown
|
1 Participants
n=5 Participants
|
|
Psoriatic arthritis
No
|
18 Participants
n=5 Participants
|
|
Psoriatic arthritis
Yes
|
3 Participants
n=5 Participants
|
|
Psoriasis erythrodermica
No
|
21 Participants
n=5 Participants
|
|
Psoriasis erythrodermica
Yes
|
0 Participants
n=5 Participants
|
|
Psoriasis inversa
No
|
19 Participants
n=5 Participants
|
|
Psoriasis inversa
Yes
|
2 Participants
n=5 Participants
|
|
Psoriasis pustulosa generalisata
No
|
21 Participants
n=5 Participants
|
|
Psoriasis pustulosa generalisata
Yes
|
0 Participants
n=5 Participants
|
|
Plaque Psoriasis
No
|
15 Participants
n=5 Participants
|
|
Plaque Psoriasis
Yes
|
6 Participants
n=5 Participants
|
|
Do you suffer from P. vulgaris?
No
|
15 Participants
n=5 Participants
|
|
Do you suffer from P. vulgaris?
Yes
|
6 Participants
n=5 Participants
|
|
Age at initial diagnosis of PPP
|
52.10 years
STANDARD_DEVIATION 13.58 • n=5 Participants
|
|
Number of involved Fingernails
|
1.22 nails
n=5 Participants
|
|
Number of involved Toenails
|
3.33 nails
n=5 Participants
|
PRIMARY outcome
Timeframe: PPPASI Score at baseline and Week 20.The PPPASI assess palms of hands and soles of feet for psoriasis involvement. The PPPASI score range from 0-72, with higher scores indicating more severe disease.
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at Week 20 Compared With Baseline
Visit 2 - Baseline
|
16.50 PPPASI Score
Interval 14.0 to 19.5
|
15.85 PPPASI Score
Interval 13.95 to 19.85
|
16.50 PPPASI Score
Interval 14.0 to 19.5
|
|
Palmoplantar Pustulosis Psoriasis Area and Severity Index (PPPASI) at Week 20 Compared With Baseline
Visit 5 - End of Study - Week 20
|
7.65 PPPASI Score
Interval 4.45 to 10.6
|
7.65 PPPASI Score
Interval 4.45 to 10.6
|
8.10 PPPASI Score
Interval 4.5 to 11.2
|
SECONDARY outcome
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).PPPASI 50 response defined as a 50% decrease in PPPASI from baseline.
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Number of Participants With PPPASI 50 Response
Visit 3 - Week 4
|
7 Participants
|
7 Participants
|
—
|
|
Number of Participants With PPPASI 50 Response
Visit 4 - Week 12
|
12 Participants
|
12 Participants
|
—
|
|
Number of Participants With PPPASI 50 Response
Visit 5 - End of Study - Week 20
|
13 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (Week 20).PPPASI 75 response defined as a 75% decrease in PPPASI from baseline.
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Number of Participants With PPPASI 75 Response
Visit 3 - Week 4
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With PPPASI 75 Response
Visit 4 - Week 12
|
6 Participants
|
6 Participants
|
—
|
|
Number of Participants With PPPASI 75 Response
Visit 5 - End of Study - Week 20
|
3 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: At Visit 2 (Baseline), Visit 4 (Week 12) and Visit 5 (Week 20).Population: The number analyzed in one or more rows differs from the overall number of patients included in the FAS or PPS population as DLQI score was not available for all patients at all timepoints.
The DLQI is a dermatology-specific quality of life instrument designed to assess the impact of a disease on the patient's daily life which is also validated for PPP. It is a 10-item questionnaire and can be used to assess 6 different aspects: symptoms and feelings, leisure, daily activities, work or school performance, personal relationship and treatment. The DLQI was 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 was impaired. Meaning of DLQI scores: * 0 to 1 = No effect at all on patient's life * 2 to 5 = Small effect on patient's life * 6 to 10 = Moderate effect on patient's life * 11 to 20 = Very large effect on patient's life * 21 to 30 = Extremely large effect on patient's life
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Dermatology Life Quality Index (DLQI)
Visit 2 - Baseline
|
8.50 DLQI Score
Interval 5.0 to 15.5
|
8.00 DLQI Score
Interval 5.0 to 16.0
|
—
|
|
Dermatology Life Quality Index (DLQI)
Visit 4 - Week 12
|
2.50 DLQI Score
Interval 1.0 to 10.5
|
2.50 DLQI Score
Interval 1.0 to 10.5
|
—
|
|
Dermatology Life Quality Index (DLQI)
Visit 5 - End of Study - Week 20
|
2.00 DLQI Score
Interval 1.0 to 13.0
|
2.00 DLQI Score
Interval 1.0 to 13.0
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4) , Visit 4 (Week 12) and Visit 5 (Week 20).Population: In the FAS 20 participants were analyzed in all visits, except at Visit 2 (n=21).
The H\&F PGA describes the severity of psoriasis on the hands and/or feet using five categories ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 2 - Baseline · 0 clear
|
0 Participants
|
0 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 2 - Baseline · 1 almost clear
|
0 Participants
|
0 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 2 - Baseline · 2 mild
|
2 Participants
|
2 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 2 - Baseline · 3 moderate
|
19 Participants
|
18 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 2 - Baseline · 4 severe
|
0 Participants
|
0 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 3 - Week 4 · 0 clear
|
0 Participants
|
0 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 3 - Week 4 · 1 almost clear
|
1 Participants
|
1 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 3 - Week 4 · 2 mild
|
10 Participants
|
10 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 3 - Week 4 · 3 moderate
|
9 Participants
|
9 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 3 - Week 4 · 4 severe
|
0 Participants
|
0 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 4 - Week 12 · 0 clear
|
0 Participants
|
0 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 4 - Week 12 · 1 almost clear
|
3 Participants
|
3 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 4 - Week 12 · 2 mild
|
9 Participants
|
9 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 4 - Week 12 · 3 moderate
|
8 Participants
|
8 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 4 - Week 12 · 4 severe
|
0 Participants
|
0 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 5 - End of Study - Week 20 · 0 clear
|
1 Participants
|
1 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 5 - End of Study - Week 20 · 1 almost clear
|
1 Participants
|
1 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 5 - End of Study - Week 20 · 2 mild
|
10 Participants
|
10 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 5 - End of Study - Week 20 · 3 moderate
|
8 Participants
|
8 Participants
|
—
|
|
Hand and Feet Physician Global Assessment (H&F PGA)
Visit 5 - End of Study - Week 20 · 4 severe
|
0 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Visit 2 (Baseline) and Visit 5 (End of Study - Week 20)Percentage change from baseline in Pustules count after 20 weeks of treatment with Apremilast
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Pustules Count Percent Change From Baseline
|
-76.3 Percent change
Interval -100.0 to -53.4
|
-79.82 Percent change
Interval -100.0 to -57.33
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study-Week 20).Patients experiencing a 50% and 75% decrease in Pustules count from baseline
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Number of Participants With Pustules Count 50 and 75 Response
Pustules count 50: Visit 3 - Week 4
|
13 Participants
|
14 Participants
|
—
|
|
Number of Participants With Pustules Count 50 and 75 Response
Pustules count 50: Visit 4 - Week 12
|
18 Participants
|
17 Participants
|
—
|
|
Number of Participants With Pustules Count 50 and 75 Response
Pustules count 50: Visit 5-End of Study- Week 20
|
16 Participants
|
16 Participants
|
—
|
|
Number of Participants With Pustules Count 50 and 75 Response
Pustules count 75: Visit 3 - Week 4
|
8 Participants
|
9 Participants
|
—
|
|
Number of Participants With Pustules Count 50 and 75 Response
Pustules count 75: Visit 4 - Week 12
|
14 Participants
|
14 Participants
|
—
|
|
Number of Participants With Pustules Count 50 and 75 Response
Pustules count 75: Visit 5-End of Study- Week 20
|
12 Participants
|
12 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).VAS was used to assess discomfort/pain. The patient was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary represented no discomfort/pain (at 0 mm), and the right-hand boundary (at 100 mm) represented discomfort/pain as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded, with higher values indicating more discomfort/pain (worse conditions).
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) Discomfort/Pain
Visit 2 - Baseline
|
44.0 Units on a scale
Interval 11.0 to 67.0
|
37.5 Units on a scale
Interval 9.0 to 61.0
|
—
|
|
Visual Analogue Scale (VAS) Discomfort/Pain
Visit 3 - Week 4
|
4.0 Units on a scale
Interval 0.0 to 19.0
|
3.0 Units on a scale
Interval 0.0 to 19.0
|
—
|
|
Visual Analogue Scale (VAS) Discomfort/Pain
Visit 4 - Week 12
|
2.0 Units on a scale
Interval 0.0 to 27.0
|
1.5 Units on a scale
Interval 0.0 to 21.0
|
—
|
|
Visual Analogue Scale (VAS) Discomfort/Pain
Visit 5 - End of Study - Week 20
|
9.0 Units on a scale
Interval 3.0 to 61.0
|
7.5 Units on a scale
Interval 2.5 to 29.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).VAS was used to assess pruritus/itch. The patient was asked to place a vertical stroke on a 100 mm VAS on which the left-hand boundary (at 0 mm) represented no pruritus/itch, and the right-hand boundary (at 100 mm) represented pruritus/itch as severe as can be imagined. The distance from the mark to the left-hand boundary was recorded, with higher values indicating more pruritus/itch (worse outcomes).
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=21 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
n=20 Participants
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) Pruritus/Itch
Visit 2 - Baseline
|
31.0 Units on a scale
Interval 16.0 to 55.0
|
29.5 Units on a scale
Interval 12.5 to 49.0
|
—
|
|
Visual Analogue Scale (VAS) Pruritus/Itch
Visit 3 - Week 4
|
2.0 Units on a scale
Interval 2.0 to 48.0
|
11.0 Units on a scale
Interval 2.0 to 39.75
|
—
|
|
Visual Analogue Scale (VAS) Pruritus/Itch
Visit 4 - Week 12
|
25.0 Units on a scale
Interval 4.0 to 44.0
|
24.0 Units on a scale
Interval 3.5 to 37.25
|
—
|
|
Visual Analogue Scale (VAS) Pruritus/Itch
Visit 5 - End of Study - Week 20
|
12.0 Units on a scale
Interval 6.0 to 49.0
|
11.5 Units on a scale
Interval 5.25 to 30.25
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Visit 2 (Baseline), Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).Population: PASI score was available only for 6 patients included in the PPS population at all assessment times.
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. These values for each anatomic region are summed to yield the PASI score.
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=6 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI)
Visit 2 - Baseline
|
3.85 PASI Score
Interval 1.93 to 5.18
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI)
Visit 3 - Week 4
|
2.27 PASI Score
Interval 0.3 to 3.65
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI)
Visit 4 - Week 12
|
0.5 PASI Score
Interval 0.0 to 2.35
|
—
|
—
|
|
Psoriasis Area and Severity Index (PASI)
Visit 5-End of Study-Week 20
|
0.95 PASI Score
Interval 0.0 to 2.28
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Visit 3 (Week 4), Visit 4 (Week 12) and Visit 5 (End of Study - Week 20).The dynamic H\&F PGA describes the global improvement compared with baseline. It relies on the physician's memory of the baseline severity to evaluate the level of alteration. The categories vary between 0 (cleared) and 6 (worse).
Outcome measures
| Measure |
Full Analysis Set (FAS)
n=20 Participants
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
Per Protocol Set (PPS)
The per protocol set (PPS) consisted of all patients who received at least one dose of study drug who completed the study with no major protocol violations.
|
Full Analysis Set - LOCF
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug. Missing values were imputed by the Last Observation Carried Forward (LOCF) method.
|
|---|---|---|---|
|
Dynamic H&F PGA
Visit 3 - Week 4 · 0 cleared
|
0 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 3 - Week 4 · 1 excellent
|
2 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 3 - Week 4 · 2 good
|
4 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 3 - Week 4 · 3 slight
|
3 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 3 - Week 4 · 4 unchanged
|
4 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 3 - Week 4 · 5 fair
|
7 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 3 - Week 4 · 6 worse
|
0 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 4 - Week 12 · 0 cleared
|
0 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 4 - Week 12 · 1 excellent
|
5 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 4 - Week 12 · 2 good
|
5 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 4 - Week 12 · 3 slight
|
2 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 4 - Week 12 · 4 unchanged
|
2 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 4 - Week 12 · 5 fair
|
6 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 4 - Week 12 · 6 worse
|
0 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 5 - End of Study - Week 20 · 0 cleared
|
0 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 5 - End of Study - Week 20 · 1 excellent
|
5 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 5 - End of Study - Week 20 · 2 good
|
7 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 5 - End of Study - Week 20 · 3 slight
|
2 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 5 - End of Study - Week 20 · 4 unchanged
|
2 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 5 - End of Study - Week 20 · 5 fair
|
4 Participants
|
—
|
—
|
|
Dynamic H&F PGA
Visit 5 - End of Study - Week 20 · 6 worse
|
0 Participants
|
—
|
—
|
Adverse Events
Full Analysis Set (FAS)
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Full Analysis Set (FAS)
n=21 participants at risk
The full analysis set (FAS) consisted of all patients who received at least one dose of study drug.
|
|---|---|
|
Injury, poisoning and procedural complications
Arthropod bite
|
14.3%
3/21 • Number of events 3 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Surgical and medical procedures
Artificial crown procedure
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Surgical and medical procedures
Endodontic procedure
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Cardiac disorders
Tachycardia
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Nervous system disorders
Headache
|
23.8%
5/21 • Number of events 7 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Nervous system disorders
Nerve compression
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Nervous system disorders
Tension headache
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
General disorders
Chest discomfort
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Psychiatric disorders
Anxiety disorder
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
6/21 • Number of events 6 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.8%
5/21 • Number of events 6 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
2/21 • Number of events 2 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.5%
2/21 • Number of events 2 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Epulis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Toothache
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Infections and infestations
Nasopharyngitis
|
23.8%
5/21 • Number of events 6 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Infections and infestations
Cystitis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Infections and infestations
Gastrointestinal infection
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Infections and infestations
Influenza
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Infections and infestations
Respiratory tract infection
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Infections and infestations
Sinusitis
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • All AEs were monitored/assessed from baseline (Visit 2, onset of treatment) until the patient's last study visit (i.e., up to 20 weeks). All SAEs were monitored/assessed upon ICF signature (Visit 1) until 30 days after the patient had stopped study participation (i.e., up to 24 weeks plus 30 days).
The date of onset, intensity, relationship of the AE to study drug, action(s) taken, seriousness, time course, duration and outcome were recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place