Trial Outcomes & Findings for AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis (NCT NCT01300052)
NCT ID: NCT01300052
Last Updated: 2017-04-17
Results Overview
PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84.
COMPLETED
PHASE2
68 participants
Day 84
2017-04-17
Participant Flow
Participant milestones
| Measure |
AN2728 Ointment, 2%
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator
|
AN2728 Ointment, Vehicle
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
22
|
|
Overall Study
COMPLETED
|
40
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
AN2728 Ointment, 2%
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator
|
AN2728 Ointment, Vehicle
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis
Baseline characteristics by cohort
| Measure |
AN2728 Ointment, 2%
n=46 Participants
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=22 Participants
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 84Population: ITT population included all randomized participants who received the study medication. Missing data was imputed using last observation carried forward (LOCF) method.
PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 84.
Outcome measures
| Measure |
AN2728 Ointment, 2%
n=46 Participants
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=22 Participants
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84
|
17.4 percentage of participants
Interval 6.4 to 28.3
|
13.6 percentage of participants
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: Day 14, Day 28, Day 42, Day 56, Day 70Population: ITT population included all randomized participants who received the study medication.
PGA assessed severity of overall disease activity in participants. It was performed using a 6-point scale graded from 0 - 5, in which 0 = clear (no plaque elevation above normal skin level), 1 = almost clear (essentially flat with possible trace elevation), 2 = mild (slight but definite elevation of plaque above normal skin level), 3 = moderate (moderate elevation with rounded or sloped edges to plaque), 4 = severe (marked elevation with hard, sharp edges to plaque), 5 = very severe (very marked elevation with very hard, sharp edges to plaque). The success in PGA of disease severity was defined as a PGA score of '0 = clear' or '1 = almost clear', with at least 2-grade improvement in PGA from Baseline to Day 14, 28, 42, 56 and 70.
Outcome measures
| Measure |
AN2728 Ointment, 2%
n=46 Participants
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=22 Participants
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70
Day 14
|
2.2 percentage of participants
Interval 0.0 to 6.4
|
0 percentage of participants
95% Confidence Interval was not evaluable as there were no participants who achieved success in PGA at the specified time point
|
|
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70
Day 28
|
8.7 percentage of participants
Interval 0.6 to 16.8
|
4.5 percentage of participants
Interval 0.0 to 13.2
|
|
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70
Day 42
|
26.1 percentage of participants
Interval 13.4 to 38.8
|
18.2 percentage of participants
Interval 2.1 to 34.3
|
|
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70
Day 56
|
21.7 percentage of participants
Interval 9.8 to 33.7
|
13.6 percentage of participants
Interval 0.0 to 28.0
|
|
Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Days 14, 28, 42, 56, and 70
Day 70
|
17.4 percentage of participants
Interval 6.4 to 28.3
|
13.6 percentage of participants
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 84Population: ITT population included all randomized participants who received the study medication. Missing data was imputed using LOCF method.
Percentage of the total body surface area (BSA) involved with psoriasis was measured. Change from Baseline (Day 1) in percentage of BSA at Day 84 was reported.
Outcome measures
| Measure |
AN2728 Ointment, 2%
n=46 Participants
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=22 Participants
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84
|
-2.1 percentage of body surface area
Standard Deviation 3.20
|
-1.4 percentage of body surface area
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 84Population: Safety population included all randomized participants with confirmed usage of the study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.
Outcome measures
| Measure |
AN2728 Ointment, 2%
n=46 Participants
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=22 Participants
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
23 participants
|
12 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 84Population: Safety population included all randomized participants with confirmed usage of the study medication.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were classified according to the severity in 3 categories a) mild =AEs does not interfere with participant's usual function b) moderate =AEs interfered to some extent with participant's usual function c) severe =AEs interfered significantly with participant's usual function and required systemic drug therapy. Treatment-emergent were events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pretreatment state. In this outcome measure, number of mild, moderate and severe TEAEs were reported.
Outcome measures
| Measure |
AN2728 Ointment, 2%
n=46 Participants
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=22 Participants
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Moderate
|
25 adverse events
|
5 adverse events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Severe
|
5 adverse events
|
5 adverse events
|
|
Number of Treatment-Emergent Adverse Events (TEAEs) by Severity
Mild
|
14 adverse events
|
11 adverse events
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 84Population: Safety population included all randomized participants with confirmed usage of the study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Local tolerability in participants was evaluated in terms of presence and absence of burning/stinging symptom and its severity in the areas of body where medication was applied. Burning/stinging symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no stinging/ burning), 1 =mild (slight warm, tingling sensation), 2 = moderate (definite warm; tingling/stinging sensation), 3 = severe (hot, tingling/stinging sensation that caused definite discomfort). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe burning/stinging symptoms were reported.
Outcome measures
| Measure |
AN2728 Ointment, 2%
n=40 Participants
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=19 Participants
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Number of Participants With Local Tolerability Symptoms: Burning/Stinging
None
|
31 participants
|
18 participants
|
|
Number of Participants With Local Tolerability Symptoms: Burning/Stinging
Mild
|
5 participants
|
1 participants
|
|
Number of Participants With Local Tolerability Symptoms: Burning/Stinging
Moderate
|
4 participants
|
0 participants
|
|
Number of Participants With Local Tolerability Symptoms: Burning/Stinging
Severe
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) up to Day 84Population: Safety population included all randomized participants with confirmed usage of the study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
Local tolerability was evaluated in participants in terms of presence and absence of pruritus symptom and its severity in the areas of body where medication was applied. Pruritus symptoms were graded on a 4-point scale of 0 - 3 where 0 =none (no pruritus), 1 =mild (occasional, slight itching/scratching), 2 = moderate (constant or intermittent itching/scratching which was not disturbing sleep), 3 = severe (bothersome itching/scratching which was disturbing sleep). Higher scores=Severe symptoms. In this outcome measure, number of participants with none, mild, moderate and severe pruritus symptoms were reported.
Outcome measures
| Measure |
AN2728 Ointment, 2%
n=40 Participants
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=19 Participants
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Number of Participants With Local Tolerability Symptoms: Pruritus
None
|
23 participants
|
13 participants
|
|
Number of Participants With Local Tolerability Symptoms: Pruritus
Mild
|
8 participants
|
6 participants
|
|
Number of Participants With Local Tolerability Symptoms: Pruritus
Moderate
|
5 participants
|
0 participants
|
|
Number of Participants With Local Tolerability Symptoms: Pruritus
Severe
|
4 participants
|
0 participants
|
Adverse Events
AN2728 Ointment, 2%
AN2728 Ointment, Vehicle
Serious adverse events
| Measure |
AN2728 Ointment, 2%
n=46 participants at risk
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=22 participants at risk
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/46
|
4.5%
1/22
|
|
Nervous system disorders
Convulsion
|
0.00%
0/46
|
4.5%
1/22
|
Other adverse events
| Measure |
AN2728 Ointment, 2%
n=46 participants at risk
AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
AN2728 Ointment, Vehicle
n=22 participants at risk
AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
2.2%
1/46
|
0.00%
0/22
|
|
General disorders
Application site pain
|
2.2%
1/46
|
0.00%
0/22
|
|
General disorders
Application site pruritus
|
2.2%
1/46
|
0.00%
0/22
|
|
General disorders
Application site rash
|
2.2%
1/46
|
0.00%
0/22
|
|
General disorders
Medical device pain
|
2.2%
1/46
|
0.00%
0/22
|
|
General disorders
Oedema peripheral
|
4.3%
2/46
|
4.5%
1/22
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/46
|
4.5%
1/22
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/46
|
4.5%
1/22
|
|
Immune system disorders
Hypersensitivity
|
2.2%
1/46
|
0.00%
0/22
|
|
Immune system disorders
Seasonal allergy
|
2.2%
1/46
|
0.00%
0/22
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/46
|
4.5%
1/22
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/46
|
4.5%
1/22
|
|
Infections and infestations
Influenza
|
0.00%
0/46
|
4.5%
1/22
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
4/46
|
4.5%
1/22
|
|
Infections and infestations
Sinusitis
|
2.2%
1/46
|
0.00%
0/22
|
|
Infections and infestations
Tooth abscess
|
2.2%
1/46
|
0.00%
0/22
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/46
|
9.1%
2/22
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/46
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.2%
1/46
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.2%
1/46
|
0.00%
0/22
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.00%
0/46
|
4.5%
1/22
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
1/46
|
0.00%
0/22
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/46
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/46
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/46
|
4.5%
1/22
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/46
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
2.2%
1/46
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.2%
1/46
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
2.2%
1/46
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.2%
1/46
|
0.00%
0/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/46
|
4.5%
1/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/46
|
4.5%
1/22
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
2.2%
1/46
|
0.00%
0/22
|
|
Nervous system disorders
Burning sensation
|
2.2%
1/46
|
0.00%
0/22
|
|
Nervous system disorders
Dizziness
|
2.2%
1/46
|
0.00%
0/22
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.2%
1/46
|
0.00%
0/22
|
|
Renal and urinary disorders
Urinary tract pain
|
2.2%
1/46
|
0.00%
0/22
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/46
|
4.5%
1/22
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/46
|
4.5%
1/22
|
|
Skin and subcutaneous tissue disorders
Blister
|
2.2%
1/46
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.7%
4/46
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.3%
2/46
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Guttate psoriasis
|
2.2%
1/46
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
2/46
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
2.2%
1/46
|
0.00%
0/22
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/46
|
0.00%
0/22
|
|
Vascular disorders
Hypertension
|
2.2%
1/46
|
0.00%
0/22
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER