- |||||||||| AQ280 / LEO Pharma, Aqilion
Trial completion date, Trial primary completion date: SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects (clinicaltrials.gov) - Jan 17, 2023
P1, N=64, Recruiting,
Active, not recruiting --> Completed Trial completion date: Jan 2023 --> Apr 2023 | Trial primary completion date: Jan 2023 --> Apr 2023
- |||||||||| Dovonex (calcipotriol) / LEO Pharma, Novartis
Journal: Involucrin modulates vitamin D receptor activity in the epidermis. (Pubmed Central) - Jan 16, 2023
Coinciding with the dampened MC903-mediated inflammation, skin microbiota of Ivl -/- mice was more stable compared to WT mice, which exhibited a MC903-responsive increase in Bacteroidetes and decrease in Firmicutes. Together, our studies in Ivl -/- mice identify a functional role for Involucrin to positively impact Vdr activity and suggest an emerging IVL/VDR paradigm for adaptation in the human epidermis.
- |||||||||| orismilast oral (LEO 32731) / UNION Therap
Trial completion: IASOS: Study to Assess the Efficacy and Safety of Orismilast in Psoriasis (clinicaltrials.gov) - Jan 11, 2023
P2b, N=202, Completed,
Active, not recruiting --> Completed | N=240 --> 113 | Trial completion date: Mar 2024 --> Dec 2022 | Trial primary completion date: Jul 2023 --> Sep 2022 Active, not recruiting --> Completed
- |||||||||| LP0200 / LEO Pharma
Trial completion, Trial completion date, Trial primary completion date: A Single and Multiple Ascending-dose Trial of LEO 153339 in Healthy Adults (clinicaltrials.gov) - Jan 11, 2023
P1, N=108, Completed,
Active, not recruiting --> Completed Recruiting --> Completed | Trial completion date: Nov 2022 --> Jul 2022 | Trial primary completion date: Nov 2022 --> Jul 2022
- |||||||||| Dovonex (calcipotriol) / LEO Pharma, Novartis
Preclinical, Journal: Topical Skullcapflavone II attenuates atopic dermatitis in a mouse model by directly inhibiting associated cytokines in different cell types. (Pubmed Central) - Jan 7, 2023
We aimed to validate SFII for atopic dermatitis (AD) therapy by demonstrating the anti-inflammatory effects of SFII in an AD mouse model produced by the topical application of the vitamin D3 analog MC903...Lastly, we demonstrated that topical SFII more effectively suppressed serum IgE levels, the production of IL-4 and thymic stromal lymphopoietin (TSLP), and infiltration of CD4 T cells and Gr-1 cells (neutrophils) into lesion skin compared to topical baicalein (a flavonoid derived from Scutellaria baicalensis), which has anti-inflammatory effects. Taken together, our findings suggest that SFII may have promising therapeutic potential for this complex disease via the regulation of multiple AD-associated targets.
- |||||||||| izuforant (JWP1601) / LEO Pharma
Trial completion: A Trial to Evaluate the Effect of LEO 152020 on the Heart of Healthy People (clinicaltrials.gov) - Jan 6, 2023
P1, N=28, Completed,
Taken together, our findings suggest that SFII may have promising therapeutic potential for this complex disease via the regulation of multiple AD-associated targets. Recruiting --> Completed
- |||||||||| Dupixent (dupilumab) / Sanofi, Regeneron, Dovonex (calcipotriol) / LEO Pharma, Novartis
Journal: IL-4Rα signalling in B cells and T cells play differential roles in acute and chronic atopic dermatitis. (Pubmed Central) - Jan 5, 2023
Targeting interleukin 4 receptor alpha (IL-4Rα), an IL-4/IL-13 signalling axis, with dupilumab shows efficacy in AD...We used House dust mite (HDM) and Ovalbumin (OVA) in chronic models and a low-calcemic analog of vitamin D (MC903) for acute models of AD...IL-4Rα-responsive T cells were essential in epidermal thickening in the pan-T cell, but not CD4 or CD8 T cells suggesting the importance of γδT cells during acute AD. Our results suggest that IL-4Rα responsiveness on innate T cells regulates acute atopic dermatitis, while on B cells it regulates IgE.
- |||||||||| Dovonex (calcipotriol) / LEO Pharma, Novartis
Journal: A role for age-associated alterations in esophageal epithelium in eosinophilic esophagitis-associated fibrosis. (Pubmed Central) - Jan 3, 2023
We find that induction of EoE inflammation in young and aged mice using the MC903/Ovalbumin protocol for the same time period results in increased lamina propria thickness uniquely in aged animals...Finally, to identify potential mechanisms through which aged esophageal epithelial cells may stimulate fibrotic remodeling, we perform cytokine array experiments in young and aged mice. These studies are significant as identification of age-associated factors that contribute to fibrotic remodeling may aid in the design of strategies toward early detection, prevention, and therapy of fibrostenotic EoE.
- |||||||||| Journal: English version of Japanese guidance for use of biologics for psoriasis (the 2022 version). (Pubmed Central) - Dec 31, 2022
Furthermore, after 2018, the anti-IL23p19 antibody preparations guselkumab and risankizumab, the TNF inhibitor certolizumab pegol, the IL-23 inhibitor tildrakizumab, and the anti-IL-17A/F antibody bimekizumab were marketed...The followings can be listed as points to be considered for the selection of biologics: drug effects (e.g., strength of effectiveness, time to onset of effectiveness, effectiveness against arthritis, primary failure, secondary failure), safety (e.g., infections, administration-related reactions, and relationships with other comorbidities), convenience for patients (e.g., hospital visit intervals, self-injection, maintenance therapy at clinics, feasibility of drug discontinuation/re-administration), and payment (medical costs) borne by patients. This guidance has been prepared with the aim of allowing dermatologists experienced in the treatment of psoriasis to use biologics appropriately according to the circumstances of individual patients after consideration of the above-mentioned factors.
- |||||||||| Review, Journal: Monoclonal antibodies in the management of asthma: Dead ends, current status and future perspectives. (Pubmed Central) - Dec 24, 2022
In addition, as available monoclonal antibody treatments have shown little benefit among patients with T-low asthma, research continues in this area, with several antibodies in development. This article summarizes the available pre-clinical and clinical data on new and emerging drugs for treating severe asthma, discusses discontinued treatments and outlines future directions in this area.
- |||||||||| Olumiant (baricitinib) / Incyte, Eli Lilly, Dupixent (dupilumab) / Sanofi, Regeneron, Corectim (delgocitinib) / Japan Tobacco, LEO Pharma, Rohto Pharma
Journal: THE BRIEF COMMENTARY ON GUIDELINES FOR THE MANAGEMENT OF ATOPIC DERMATITIS 2021 (Pubmed Central) - Dec 22, 2022
This article summarizes the available pre-clinical and clinical data on new and emerging drugs for treating severe asthma, discusses discontinued treatments and outlines future directions in this area. No abstract available
- |||||||||| U012 - Practical Considerations for Systemic Treatment of Atopic Dermatitis in Adults (Room 344) - Dec 22, 2022 - Abstract #AAD2023AAD_53;
Differentiate the advantages and disadvantages of available systemic treatment options for atopic dermatitis in special populations of adults, including older adults and adults with comorbidities. Recognize adverse events associated with systemic treatments for atopic dermatitis and how to monitor for and manage them.
- |||||||||| Review, Journal: Modern Interventions for Pediatric Atopic Dermatitis: An Updated Pharmacologic Approach. (Pubmed Central) - Dec 20, 2022
In this review, we discuss emerging topical and systemic (oral and injectable) treatments in pediatric AD, including topical PDE4 inhibitors and tapinarof, oral JAK inhibitors, and injected biologics including IL-4Rα inhibitor dupilumab, IL-13 inhibitor tralokinumab, IL-13Rα inhibitor lebrikizumab, IL-31Rα inhibitor nemolizumab, and IL-5Rα inhibitor benralizumab...Finally, we propose a therapeutic approach for pediatric AD that incorporates newer therapies including dupilumab and JAK inhibitors, recognizing that these agents may not be universally available or approved. Further trials that include pediatric patients, especially head-to-head studies among therapeutic classes, are needed to clarify the role of emerging treatments.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Dovonex (calcipotriol) / LEO Pharma, Novartis
Journal: CD1a promotes systemic manifestations of skin inflammation. (Pubmed Central) - Dec 9, 2022
Similar systemic escalation is shown in MC903-induced skin inflammation...The beneficial effect is epitope dependent, and we further characterise the five best-performing antibodies for their capacity to modulate CD1a-expressing cells and ameliorate CD1a-dependent systemic inflammatory responses. In summary, we show that a therapeutically targetable CD1a-dependent pathway may play a role in the systemic spread of cutaneous inflammation.
- |||||||||| Corectim (delgocitinib) / Japan Tobacco, LEO Pharma, Rohto Pharma
Enrollment closed: A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia (clinicaltrials.gov) - Dec 9, 2022
P2a, N=35, Active, not recruiting,
In summary, we show that a therapeutically targetable CD1a-dependent pathway may play a role in the systemic spread of cutaneous inflammation. Recruiting --> Active, not recruiting
- |||||||||| Adbry (tralokinumab) / LEO Pharma, AstraZeneca
3101 Atopic Dermatitis: New Insights from Bench to Bedside to Populations (Convention Center, Lobby Level, Hall 2) - Dec 5, 2022 - Abstract #AAAAI2023AAAAI_27;
It also includes clinical advances including novel therapeutics recently approved and soon to be approved, such as 3 oral JAK inhibitors and tralokinumab. Finally, it presents recommendations and new meta analytic data from a Joint Task Force on Practice Parameters workgroup which has nearly completed the Atopic Dermatitis practice parameter update, using a systematic review and Grading of Recommendations, Assessment, Development Evaluation (GRADE) analysis.
- |||||||||| Corectim (delgocitinib) / Japan Tobacco, LEO Pharma, Rohto Pharma
Enrollment closed: Pharmacokinetics of Delgocitinib 20 mg/g Cream in Subjects With Chronic Hand Eczema (clinicaltrials.gov) - Dec 1, 2022
P1, N=15, Active, not recruiting,
Finally, it presents recommendations and new meta analytic data from a Joint Task Force on Practice Parameters workgroup which has nearly completed the Atopic Dermatitis practice parameter update, using a systematic review and Grading of Recommendations, Assessment, Development Evaluation (GRADE) analysis. Recruiting --> Active, not recruiting
- |||||||||| patidegib topical (IPI-926 topical) / Bridge Biotherap, LEO Pharma
Review, Journal: Topical Delivery of Hedgehog Inhibitors: Current Status and Perspectives. (Pubmed Central) - Nov 27, 2022
In clinical trials, only topical patidegib and sonidegib led to at least a partial response in 26/86 BCCs and 30/34 patients, respectively...In conclusion, the incomplete clinical response could be due to poor HHi uptake, biodistribution or biological response over time. Novel topical delivery techniques may improve HHi delivery, but additional research on cutaneous pharmacokinetics and biological response is needed.
- |||||||||| rivaroxaban / Generic mfg.
Trial completion: SECRET: Study of Rivaroxaban for CeREbral Venous Thrombosis (clinicaltrials.gov) - Nov 23, 2022
P2, N=55, Completed,
Finally, this work can be helpful to design and synthesize new vitiligo treatments and other disease drugs. Recruiting --> Completed
- |||||||||| Fragmin (dalteparin sodium) / Pfizer, Eisai, Innohep (tinzaparin) / LEO Pharma
Low-Molecular-Weight Heparin Versus Standard Pregnancy Care for Women with Recurrent Miscarriage and Inherited Thrombophilia (ALIFE2): An Open-Label, Phase III Randomized Controlled Trial (ENMCC - Hall E) - Nov 23, 2022 - Abstract #ASH2022ASH_6837;
P3
Randomisation and intervention: Women were randomly assigned (1:1) to use subcutaneous LMWH once daily (enoxaparin 40 mg, dalteparin 5,000 IU, tinzaparin 4,500 IU or nadroparin 3,800 IU) versus standard pregnancy surveillance once they had a positive urine pregnancy test...Aspirin was used as co medication in 11%...Interpretation Compared with standard surveillance, the use of LMWH did not result in higher live birth rates in women who had two or more pregnancy losses and confirmed inherited thrombophilia. On the basis of our findings, we do not advise routine use of LMWH in women with recurrent pregnancy loss and confirmed inherited thrombophilia, and we advise against routine testing for inherited thrombophilia in women with recurrent pregnancy loss.
- |||||||||| Innohep (tinzaparin) / LEO Pharma
Enrollment change, Trial termination, Metastases: Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE) (clinicaltrials.gov) - Nov 17, 2022
P3, N=59, Terminated,
59 patients were included, and their data will not meet the research objectives. The sponsor has decided to prematurely stop inclusions on January 13, 2022.
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