Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase III Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients

This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Start Date01 Nov 2016

Sponsor / Collaborator

Amorepacific Corp.

NCT02748993 / CompletedPhase 1/2

A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis

This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.

Start Date01 Mar 2016

Sponsor / Collaborator

Amorepacific Corp.

NCT02757729 / CompletedPhase 2

Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase II Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients

This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Start Date01 Oct 2015

Sponsor / Collaborator

Amorepacific Corp.

100 Clinical Results associated with Asivatrep

100 Translational Medicine associated with Asivatrep

100 Patents (Medical) associated with Asivatrep

Literatures (Medical) associated with Asivatrep

01 Jun 2024·Allergy

Treatment of atopic dermatitis: Recently approved drugs and advanced clinical development programs

Review

Author: Maintz, Laura ; Müller, Svenja ; Bieber, Thomas

AbstractAtopic dermatitis (AD) represents the most common skin disease characterized by heterogeneous endophenotypes and a high disease burden. In Europe, six new systemic therapies for AD have been approved: the biologics dupilumab (anti‐interleukin‐4 receptor (IL‐4R) α in 2017), tralokinumab (anti‐IL‐13 in 2021), lebrikizumab (anti‐IL‐13 in 2023), and the oral janus kinase (JAK) inhibitors (JAKi) targeting JAK1/2 (baricitinib in 2020 in the EU) or JAK1 (upadacitinib in 2021 and abrocitinib in 2022). Herein, we give an update on new approvals, long‐term safety, and efficacy. Upadacitinib and abrocitinib have the highest short‐term efficacy among the approved systemic therapies. In responders, dupilumab and tralokinumab catch up regarding long‐term efficacy and incremental clinical benefit within continuous use. Recently, the European Medicines Agency has released recommendations for the use of JAKi in patients at risk (cardiovascular and thromboembolic diseases, malignancies, (former) smoking, and age ≥65 years). Furthermore, we give an overview on emerging therapies currently in Phase III trials. Among the topical therapies, tapinarof (aryl hydrocarbon receptor), ruxolitinib (JAK1/2i), delgocitinib (pan‐JAKi), asivatrep (anti‐transient receptor potential vanilloid), and phosphodiesterase‐4‐inhibitors (roflumilast, difamilast) are discussed. Among systemic therapies, current data on cord‐blood‐derived mesenchymal stem cells, CM310 (anti IL‐4Rα), nemolizumab (anti‐IL‐31RA), anti‐OX40/OX40L‐antibodies, neurokinin‐receptor‐1‐antagonists, and difelikefalin (κ‐opioid‐R) are reported.

01 May 2022·Annals of Translational Medicine

Study on the intervention effect and mechanism of bacillus Calmette-Guerin polysaccharide and nucleic acid injection on atopic dermatitis by targeting the transient receptor potential vanilloid subtype 1 pathway

Article

Author: Ding, Changrui ; Wu, Di ; Duan, Tingting ; Wang, Xiufen ; Lv, Shukun ; Liu, Ying ; Xu, Yulong ; Cui, Liran

BackgroundThis study aimed to explore the mechanism of Bacillus Calmette-Guerin polysaccharide and nucleic acid injection (BCG-PSN) targeting the transient receptor potential vanilloid subtype 1 (TRPV1) pathway for atopic dermatitis (AD) in mice.MethodsExperiment 1: a total of 30 Kunming (KM) mice were randomized into blank control, model, BCG-PSN low-dose (25 g/kg), BCG-PSN medium-dose (75 g/kg), BCG-PSN high-dose (225 g/kg), and positive drug (hydrocortisone 25 mg/kg) control groups. The AD model mice were established by induction with 2,4-Dinitrochlorobenzene (DNCB). After treatment in groups, the symptom score and scratching frequency in skin lesions were observed. The levels of immunoglobulin E (IgE), interleukin (IL)-4, IL-31, and IL-13 in serum were detected, as well as the levels of tumor necrosis factor-α (TNF-α), TRPV1, and nuclear factor (NF)-κB p65 in skin lesions in each group. Experiment 2: the optimal dose of BCG-PSN in Experiment 1 was adopted. A total of 20 KM mice were randomized into blank control, model, BCG-PSN, and BCG-PSN + PAC (PAC-14028) groups. The symptom score and scratching frequency in skin lesions were observed. The levels of IgE, IL-4, IL-31, and IL-13 in serum were detected, as well as the levels of TNF-α and TRPV1 in skin lesions in each group.ResultsIn Experiment 1, compared with the blank control group, the ear tissues of mice in model groups developed AD, with increased symptom score, scratching frequency, levels of IgE, IL-4, IL-31, and IL-13 in serum and levels of TNF-α, TRPV1, and NF-κB p65 in skin lesions. Compared with the model group, BCG-PSN low-dose, BCG-PSN medium-dose, BCG-PSN high-dose, and positive drug control groups had reduced AD symptoms, decreased symptom score, and decreased scratching frequency, with declined expression of each inflammatory substance, including the greatest decrease in the medium-dose group. In Experiment 2, after BCG-PSN was combined with PAC, the inflammation indexes decreased compared with those in the model group, and increased compared with those in the BCG-PSN group.ConclusionsIntramuscular BCG-PSN can target the TRPV1 pathway, inhibit inflammation, and improve the symptoms of AD mice.

01 Apr 2022·Journal of Allergy and Clinical ImmunologyQ1 · MEDICINE

Asivatrep, a TRPV1 antagonist, for the topical treatment of atopic dermatitis: Phase 3, randomized, vehicle-controlled study (CAPTAIN-AD)

Q1 · MEDICINE

Article

Author: Lee, Dong Hun ; Nam, Hyun-Jin ; Lee, Yang Won ; Park, Chun Wook ; Won, Chonghyun ; Jung, Kyoungmi ; Park, Miyoung ; Park, Chang Ook ; Chung, Bo Young ; Kim, Kyu Han ; Park, Young-Ho ; Kim, Beom Joon ; Choi, Gyeyoung

BACKGROUNDAsivatrep is a potent and selective antagonist of transient receptor potential vanilloid subfamily V member 1 (TRPV1), which plays an important role in itch and inflammation in atopic dermatitis (AD).OBJECTIVEThis current study aimed to evaluate the efficacy and safety of asivatrep cream in patients with AD.METHODSFor this phase 3 double-blind, vehicle-controlled study, patients aged ≥12 years with mild to moderate AD were enrolled and randomly assigned 2:1 to the 1.0% asivatrep or vehicle group for 8 weeks of twice-daily application (n = 240). The primary end point was the proportion of patients with an Investigator's Global Assessment score (IGA) of 0 or 1 at week 8. Standard safety assessments were conducted.RESULTSAt week 8, significantly more patients in the asivatrep group (36.0%) than in the vehicle group (12.8%) had IGA scores of 0 or 1 (P < .001); significantly more had ≥2 points of improvement on the IGA from baseline score (20.3% vs 7.7%; P = .01). The mean percentage reduction in the Eczema Area and Severity Index (EASI) score was 44.3% for the asivatrep group and 21.4% for the vehicle group at week 8 (P < .001). Significantly more asivatrep-treated patients experienced an improvement of at least 50%, 75%, and 90% on the EASI than the vehicle group. The mean ± SD change in the pruritus visual analog scale score at week 8 was -2.3 ± 2.4 for the asivatrep group and -1.5 ± 2.4 for the vehicle group (P = .02). No significant safety issues were reported.CONCLUSIONAsivatrep improved clinical signs and symptoms of AD and was well tolerated.

100 Deals associated with Asivatrep

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB12428

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acne Vulgaris	Phase 3	-	Amorepacific Corp.	-
Pruritus	Phase 3	-	Amorepacific Corp.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis