NCT01300052

AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis

Completed Phase 2 Results posted Last updated 17 April 2017

What this trial tests

Phase 2 trial testing AN2728 ointment, 2% in Psoriasis in 68 participants. Completed in 6 June 2011.

Timeline

26 January 2011

Primary endpoint
6 June 2011

6 June 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	68
Start date	26 January 2011
Primary completion	6 June 2011
Estimated completion	6 June 2011
Sites	10 locations across United States

Drugs / interventions tested

• AN2728 ointment, 2% — full drug profile →
• Ointment Vehicle

Conditions studied

• Psoriasis — all drugs for Psoriasis →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Achieved Success in Physician's Global Assessment (PGA) of Disease Severity at Day 84 Primary · Day 84

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 define

Group	Value	95% CI
AN2728 Ointment, 2%	17.4	6.4 – 28.3
AN2728 Ointment, Vehicle	13.6	0.0 – 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 Secondary · Day 14, Day 28, Day 42, Day 56, Day 70

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 define

Day 14

Group	Value	95% CI
AN2728 Ointment, 2%	2.2	0.0 – 6.4
AN2728 Ointment, Vehicle	0	NA – NA

Day 28

Group	Value	95% CI
AN2728 Ointment, 2%	8.7	0.6 – 16.8
AN2728 Ointment, Vehicle	4.5	0.0 – 13.2

Day 42

Group	Value	95% CI
AN2728 Ointment, 2%	26.1	13.4 – 38.8
AN2728 Ointment, Vehicle	18.2	2.1 – 34.3

Day 56

Group	Value	95% CI
AN2728 Ointment, 2%	21.7	9.8 – 33.7
AN2728 Ointment, Vehicle	13.6	0.0 – 28.0

Day 70

Group	Value	95% CI
AN2728 Ointment, 2%	17.4	6.4 – 28.3
AN2728 Ointment, Vehicle	13.6	0.0 – 28.0

Change From Baseline in Percentage of Body Surface Area (%BSA) Involved With Psoriasis at Day 84 Secondary · Baseline (Day 1), Day 84

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.

Group	Value	95% CI
AN2728 Ointment, 2%	-2.1	± 3.20
AN2728 Ointment, Vehicle	-1.4	± 3.22

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Secondary · Baseline (Day 1) up to Day 84

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

AEs

Group	Value	95% CI
AN2728 Ointment, 2%	23
AN2728 Ointment, Vehicle	12

SAEs

Group	Value	95% CI
AN2728 Ointment, 2%	0
AN2728 Ointment, Vehicle	2

Number of Treatment-Emergent Adverse Events (TEAEs) by Severity Secondary · Baseline (Day 1) up to Day 84

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

Mild

Group	Value	95% CI
AN2728 Ointment, 2%	14
AN2728 Ointment, Vehicle	11

Moderate

Group	Value	95% CI
AN2728 Ointment, 2%	25
AN2728 Ointment, Vehicle	5

Severe

Group	Value	95% CI
AN2728 Ointment, 2%	5
AN2728 Ointment, Vehicle	5

Number of Participants With Local Tolerability Symptoms: Burning/Stinging Secondary · Baseline (Day 1) up to Day 84

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 symp

None

Group	Value	95% CI
AN2728 Ointment, 2%	31
AN2728 Ointment, Vehicle	18

Mild

Group	Value	95% CI
AN2728 Ointment, 2%	5
AN2728 Ointment, Vehicle	1

Moderate

Group	Value	95% CI
AN2728 Ointment, 2%	4
AN2728 Ointment, Vehicle	0

Severe

Group	Value	95% CI
AN2728 Ointment, 2%	0
AN2728 Ointment, Vehicle	0

Number of Participants With Local Tolerability Symptoms: Pruritus Secondary · Baseline (Day 1) up to Day 84

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 symptom

None

Group	Value	95% CI
AN2728 Ointment, 2%	23
AN2728 Ointment, Vehicle	13

Mild

Group	Value	95% CI
AN2728 Ointment, 2%	8
AN2728 Ointment, Vehicle	6

Moderate

Group	Value	95% CI
AN2728 Ointment, 2%	5
AN2728 Ointment, Vehicle	0

Severe

Group	Value	95% CI
AN2728 Ointment, 2%	4
AN2728 Ointment, Vehicle	0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AN2728 Ointment, 2%

Serious: 0/46 (0%)

Deaths: —

AN2728 Ointment, Vehicle

Serious: 2/22 (9%)

Deaths: —

Serious adverse events (2 terms)

Reaction	System	AN2728 Ointment, 2%	AN2728 Ointment, Vehicle
Cholecystitis infective	Infections and infestations	—	—
Convulsion	Nervous system disorders	—	—

Other adverse events (49 terms — click to expand)

Reaction	System	AN2728 Ointment, 2%	AN2728 Ointment, Vehicle
Nasopharyngitis	Infections and infestations	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—
Oedema peripheral	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Gastritis	Gastrointestinal disorders	—	—
Application site pain	General disorders	—	—
Application site pruritus	General disorders	—	—
Application site rash	General disorders	—	—
Medical device pain	General disorders	—	—
Cholecystitis	Hepatobiliary disorders	—	—
Cholelithiasis	Hepatobiliary disorders	—	—
Hypersensitivity	Immune system disorders	—	—
Seasonal allergy	Immune system disorders	—	—
Gastroenteritis viral	Infections and infestations	—	—
Herpes zoster	Infections and infestations	—	—
Influenza	Infections and infestations	—	—
Sinusitis	Infections and infestations	—	—
Tooth abscess	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Skeletal injury	Injury, poisoning and procedural complications	—	—
Alanine aminotransferase increased	Investigations	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—
Hypercholesterolaemia	Metabolism and nutrition disorders	—	—
Type 2 diabetes mellitus	Metabolism and nutrition disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Plantar fasciitis	Musculoskeletal and connective tissue disorders	—	—
Tendonitis	Musculoskeletal and connective tissue disorders	—	—
Brain cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Burning sensation	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Nephrolithiasis	Renal and urinary disorders	—	—

Most-reported serious reactions: Cholecystitis infective, Convulsion.

Data from ClinicalTrials.gov NCT01300052 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Overview of PDE4 Inhibitors in Clinical Trials: 2010 to Early 2022.
   Crocetti L, Floresta G, Cilibrizzi A, Giovannoni MP. · · 2022 · cited 85× · PMID 35956914 · DOI 10.3390/molecules27154964
2. Clinical Implication of Phosphodiesterase-4-Inhibition.
   Schick MA, Schlegel N. · · 2022 · cited 56× · PMID 35163131 · DOI 10.3390/ijms23031209
3. Personalized medicine-concepts, technologies, and applications in inflammatory skin diseases.
   Litman T. · · 2019 · cited 51× · PMID 31124204 · DOI 10.1111/apm.12934
4. Key Signaling Pathways in Psoriasis: Recent Insights from Antipsoriatic Therapeutics.
   Ben Abdallah H, Johansen C, Johansen C, Iversen L. · · 2021 · cited 48× · PMID 34235053 · DOI 10.2147/ptt.s294173
5. Phosphodiesterase-4 Inhibition in the Management of Psoriasis.
   Crowley EL, Gooderham MJ. · · 2023 · cited 24× · PMID 38258034 · DOI 10.3390/pharmaceutics16010023