A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-site, Parallel-group, Dose-finding Trial to Evaluate the Efficacy and Safety of Different Doses of Subcutaneously Administered LEO 138559 in Adult Subjects With Moderate-to-severe Atopic Dermatitis

The purpose of this trial is to test different doses of the trial medicine (LEO 138559) and see how well they work and how safe they are at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses.
The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks.
The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin.
At each visit the doctor will check the participants atopic dermatitis and if they have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life.
LEO 138559 is also called "Temtokibart".

Start Date20 Sep 2023

Sponsor / Collaborator

Leo Pharma, Inc.

NCT05470114

/ CompletedPhase 2

A Randomized, Double-blinded, Active Comparator-controlled, 16-week, Single-site, Exploratory, Mechanistic Trial to Assess the Effect of LEO 138559 on the Molecular Signature and Safety in Adults With Moderate to Severe Atopic Dermatitis.

This clinical trial will investigate the effectiveness and safety of a new active ingredient (LEO 138559) in the treatment of moderate to severe atopic dermatitis (AD). It is given by subcutaneous injection. Some people in the trial will instead receive Dupixent® which is an approved treatment for moderate to severe AD. Dupixent® is also given by subcutaneous injection.
The main aim of this clinical trial is to investigate which changes in biomarkers in the skin are caused by LEO 138559 and Dupixent®.
The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16 weeks, and a safety follow-up period of 16 weeks.

Start Date19 May 2022

Sponsor / Collaborator

Leo Pharma, Inc.

NCT05099133

/ CompletedPhase 1

A Phase 1, Single-center, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects

This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects.
The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85.
A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.

Start Date03 Nov 2021

Sponsor / Collaborator

Leo Pharma, Inc.

100 Clinical Results associated with Temtokibart

100 Translational Medicine associated with Temtokibart

100 Patents (Medical) associated with Temtokibart

Literatures (Medical) associated with Temtokibart

01 Mar 2026·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Targeting IL-22RA1 with temtokibart: A novel approach in atopic dermatitis: Phase 2a monotherapy study results

Article

Author: Lynde, Charles ; Thaçi, Diamant ; Blemings, Allan ; Worm, Margitta ; Gooderham, Melinda ; Sørensen, Ole E ; Olesen, Martin ; Martel, Britta C ; Litman, Thomas ; Reich, Adam ; Arlert, Petra ; Laquer, Vivian ; Soong, Weily

BACKGROUND:

Atopic dermatitis (AD) is a chronic inflammatory skin disease in which increased IL-22 expression contributes to epidermal hyperplasia and barrier defects. Temtokibart is a monoclonal antibody targeting IL-22RA1 (IL-22 receptor subunit alpha-1), blocking the signaling of IL-22 and potentially also of IL-20 and IL-24.

OBJECTIVE:

We evaluated the efficacy and safety of temtokibart in adults with moderate-to-severe AD.

METHODS:

In this phase 2a study (NCT04922021), 58 adults were randomized 1:1 to subcutaneous temtokibart 450 mg or placebo every 2 weeks for 16 weeks, with an additional dose (450 mg) at week 1, followed by additional 16 weeks of safety follow-up. The primary end point was change in Eczema Area Severity Index (EASI) from baseline to week 16. Biomarkers in serum, including IL-22, were analyzed as an exploratory end point.

RESULTS:

Mean change in EASI from baseline to week 16 was significantly greater for temtokibart compared to placebo (-15.3 vs -3.5; P = .003), corresponding to 65.4% and 19.7% improvement for temtokibart and placebo groups, respectively. At week 16, greater proportions of patients receiving temtokibart relative to placebo obtained EASI-75 (41.6% vs 13.7%; P = .011), EASI-90 (30.8% vs 3.5%; P = .003), and EASI-100 (20.9% vs 0%; P = .006). Treatment with temtokibart was well tolerated, and no safety signals were observed. Further, temtokibart treatment was associated with a general reduction of systemic inflammatory proteins.

CONCLUSIONS:

This proof-of-concept study demonstrates that targeting the IL-22 pathway with temtokibart is clinically effective with a favorable safety profile.

01 Mar 2026·JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY

Neutralizing IL-22RA1 improves histologic and molecular alterations associated with atopic dermatitis pathogenesis

Article

Author: Mortensen, Mette Sidsel ; Jargosch, Manja ; Pilz, Anna Caroline ; Skak-Nielsen, Tine ; Lauffer, Felix ; Wasserer, Sophia ; Hillig, Christina ; Bertelsen, Malene ; Ursoe, Birgitte ; Menden, Michael ; Garzorz-Stark, Natalie ; Eyerich, Kilian ; Eyerich, Stefanie ; Blanchetot, Christophe ; Martel, Britta C ; Litman, Thomas ; Biedermann, Tilo ; Hebsgaard, Josephine

BACKGROUND:

Disease of a subgroup of patients with atopic dermatitis (AD) does not show sufficient improvement with current systemic therapies, highlighting the heterogeneity of the chronic inflammatory skin disease and the need for novel treatments.

OBJECTIVE:

In this study, we investigated the pathogenic contribution of the IL-22/IL-22 receptor (IL-22RA1) axis to AD skin inflammation in in vitro, ex vivo, and in vivo models to evaluate the therapeutic potential of blocking this axis.

METHODS:

IL22RA1 expression in AD skin was assessed by in situ hybridization. Inhibition of the IL-22/IL-22R signaling cascade was evaluated in a human AD in vitro model (3-D skin equivalents) and a phorbol 12-myristate 13-acetate (aka TPA) mouse model using temtokibart, a humanized antibody directed against IL-22RA1.

RESULTS:

IL22RA1 was highly expressed in the epidermis of lesional AD skin versus nonlesional control skin; expression correlated positively with epidermal thickness and negatively with the barrier integrity marker loricrin. IL-22 stimulation in 3-D skin equivalents induced a specific molecular signature associated with lack of terminal differentiation, altered lipid metabolism, and increased immune response. Inhibition of IL-22RA1 with temtokibart showed significant improvements in skin barrier integrity at the histologic and molecular levels. IL-22RA1 inhibition in a skin inflammation mouse model with Zymo, a surrogate murine anti-IL-22RA1 monoclonal antibody for temtokibart, reduced local expression of Cxcl1 and S100a9.

CONCLUSIONS:

These findings suggest that the IL-22/IL-22RA1 axis functionally contributes to AD pathogenesis. Thus, blocking IL-22RA1 represents a potentially valuable new therapeutic option.

01 Dec 2024·POULTRY SCIENCE

Optimal glycine allowance levels in low-protein diets and the dynamic requirement model for broilers

Article

Author: Gong, Lu ; Gao, Xuyang ; Ma, Jiran ; Wang, Bin ; Zhao, Yizhu ; Lv, Zengpeng ; Liu, Yongfa ; Guo, Yuming ; Guo, Siyan

This study aimed to investigate the effects of different glycine levels in low-protein diets on the growth, nitrogen deposition, and expression of intestinal amino acid and glucose transporters in broilers from 29 to 42 d of age, in order to determine the optimal glycine supplementation level. A total of 240 male broilers at 29 days old were randomly assigned to 5 groups: the control group with a crude protein level of 20%, and experimental groups with low-protein diets (LP130) containing 18% crude protein, supplemented with glycine to achieve standardized ileal digestible (SID) glycine + serine to lysine ratios of 134% (LP134), 140% (LP140), and 145% (LP145). The results showed that the LP134 group had similar growth performance and slaughter performance compared to the control group (P > 0.05), whereas other low-protein diet groups had significantly lower growth performance (P < 0.05). Regression analysis determined that the optimal ratio for SID glycine + serine to lysine was 137%. A dynamic model for glycine + serine requirements was established through binary regression analysis: y = 599.051 × BW^{^0.75} + 8.381 × ADG (R² = 0.998, P < 0.001). Feeding LP134, LP140, and LP145 diets significantly improved nitrogen deposition rates in broilers (P < 0.05). Low-protein diets significantly upregulated mRNA levels of b^0,+AT, EAAT3, and SGLT1 genes in the duodenum (P < 0.05). In conclusion, appropriate glycine supplementation in low-protein diets can enhance growth performance, and nitrogen deposition efficiency, and regulate the expression of intestinal amino acid and glucose transporters. The optimal ratio of SID glycine + serine to lysine in low-protein diets for broilers aged 29 to 42 d is 137%.

News (Medical) associated with Temtokibart

17 Sep 2025

·www.businesswire.com

LEO Pharma presents two late-breaking abstracts for temtokibart reporting positive Phase 2b efficacy, safety and biomarker results in moderate-to-severe atopic dermatitis at the 2025 EADV Annual Meeting in Paris

Results presented at EADV 2025 demonstrated that investigational agent temtokibart met its primary endpoint of percentage change in the Eczema Area and Severity Index (EASI) compared with placebo for the three highest doses (600 mg, 450 mg, and 300 mg) 1 Significantly greater improvements in EASI were reported as early as Week 1 for temtokibart 450mg and 300mg, and Week 2 for 600mg, vs placebo; these results were maintained up to Week 32 in 600mg and 300mg arms, despite no treatment after Week 14 1 Safety analyses revealed that temtokibart was well-tolerated with no dose-dependent AEs, a low incidence of conjunctivitis, and no signal for herpes 1 BALLERUP, Denmark--(BUSINESS WIRE)--NOT FOR UK USE – NOT INTENDED FOR UK MEDIA LEO Pharma A/S, a global leader in medical dermatology, today presented two late-breaking presentations showcasing the results of a Phase 2b dose finding trial evaluating the efficacy and safety of investigational agent temtokibart in adults with moderate-to-severe atopic dermatitis (AD). The trial met its primary endpoint for the three highest doses, further supported by biomarker results showing broad dampening of markers for activated immune pathways in AD. Results were shared in two LEO Pharma late breaker oral presentations at the 2025 European Academy of Dermatology and Venereology (EADV) Annual Meeting.1,2 Temtokibart (also called LEO 138559) is an investigational agent that is not approved by any health authority. It’s safety and efficacy have not yet been established and are subject to further larger trials. The Phase 2b study was a randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart, in adult subjects with moderate-to-severe AD.1,3 Temtokibart is an investigational monoclonal antibody for the treatment of moderate-to-severe AD, which blocks the IL-22RA1 receptor subunit thereby inhibiting the effect of the interleukin-22 (IL-22) cytokine (known to be elevated in pathway with atopic dermatitis), and also the effects of IL-20 and IL-24 signaling.4–6 Phase 2b efficacy and safety late breaking abstract presented by Professor Stephan Weidinger The results from the Phase 2b trial in 262 adult patients showed that temtokibart demonstrated significant improvement in the primary endpoint of percentage change in EASI from baseline for 600 mg (−61.2%, p<0.01), 450 mg (−57.1%, p<0.05), and 300 mg (−64.3%, p<0.01) treatment arms compared with placebo (−41.7%) at Week 16.1 Significant improvement was observed in percentage change in EASI as early as Week 1 for 450 mg (−22.3%; p<0.01) and 300 mg arms (−19.6%; p<0.05), and as early as Week 2 with 600 mg (−35.0%; p<0.05) compared with placebo (Week 1: −8.0%, Week 2: (−22.7%).1 These significant improvements were maintained up to Week 32 in 600 mg (−59.1%; p<0.05) and 300 mg (−60.6%; p<0.05) arms, despite no treatment used after Week 14.1 Temtokibart was well-tolerated with no dose-dependent AEs, low incidence of conjunctivitis, and no signal for herpes.1 AEs leading to permanent drug discontinuation or withdrawal were reported in 2.4% and 3.8% of patients in the temtokibart and placebo groups, respectively.1 “These results are promising, as they provide further evidence of the value of targeting the IL-22 pathway in AD, via IL-22RA1 , offering a potential novel approach to the currently existing therapies used to treat atopic dermatitis,” said Professor Stephan Weidinger, Professor and Chair for Dermatology at the Christian-Albrechts-University, Director of the Department of Dermatology and Allergy at the University Hospital Schleswig-Holstein, Germany, and the International Coordinating Investigator for the Phase 2b trial. “Patients with moderate-to-severe atopic dermatitis still face numerous unmet needs, so we welcome any new options that could improve their disease while limiting burdensome side effects.” Phase 2b biomarker late breaking abstract, presented by Professor Emma Guttman-Yassky Biomarker results from the Phase 2b trial were also presented as a late breaker at EADV 2025 which showed that temtokibart-treated patients (pooled-temtokibart data; n=22 at baseline, n=14 at Week 16) demonstrated an overall 97% improvement in immune gene expression by Week 16.2 Expression of epidermal barrier-related genes were significantly restored by Week 16.2 Correlation analysis revealed that reductions in EASI and SCORAD were significantly associated with reductions in Th2 and Th17/22 markers (p≤ 0.05), and DLQI and POEM correlated with reductions of key T-cell, Th2, Th17/Th22 markers (p≤ 0.05).2 “Atopic dermatitis is a complex and heterogenous disease, and there remains a significant need for further understanding the effect of targeting different pathways. By investigating biomarkers in the clinical programs we are increasing our understanding of the disease, moving us closer to a more tailored approach of treating AD via different mechanisms of action,” said Professor Emma Guttman-Yassky, Waldman Professor of Dermatology and Immunology and the Health System Chair of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, USA, Investigator and senior author of the Phase 2b biomarker abstract. “These results provide further evidence that the IL-22 pathway is a key driver of disease activity in AD and that there is a strong correlation between clinical effects and dampening of several immune pathways of importance in AD, when targeting the IL-22RA1 subunit.” “We are encouraged by these Phase 2b results which further add to the potential clinical value of temtokibart in moderate-to-severe atopic dermatitis,” said Professor Jacob Pontoppidan Thyssen, Chief Scientific Officer & Executive Vice President, Science, Search & Innovation at LEO Pharma. About the Phase 2b trial The temtokibart phase 2b trial (NCT05923099) is a randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial, evaluating efficacy and safety of different doses of subcutaneously administered temtokibart in adult patients with moderate-to-severe atopic dermatitits.1 Patients were randomized to receive one of four doses of temtokibart or placebo.1 The primary endpoint is percent change in EASI from baseline to Week 16.3 The key secondary endpoint is number of treatment-emergent adverse events from baseline to Week 16 per subject.3 About atopic dermatitis Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions.7 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.8 Type 2 and IL-22 pathways play an important role in the key aspects of atopic dermatitis pathophysiology.9–12 About investigational temtokibart Temtokibart is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in Phase 2 development for the potential treatment of moderate-to-severe atopic dermatitis.3,4 It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and also the effects of IL-20 and IL-24 signaling.5,6 Temtokibart does not bind to the IL-22 cytokine itself.5,6 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com. About argenx LEO Pharma and argenx, a global immunology company, formed a strategic alliance in 2015 to develop innovative antibody-based solutions for the treatment of chronic inflammation that underlies many skin conditions. LEO Pharma and argenx jointly developed temtokibart under this research agreement and LEO Pharma has subsequently obtained the exclusive license to develop and commercialize temtokibart. References: Weidinger S, et al. Presented at European Academy of Dermatology and Venereology 2025 Annual Meeting, Paris, September 17–20. Del Duca E, et al. Presented at European Academy of Dermatology and Venereology 2025 Annual Meeting, Paris, September 17–20. NCT05923099. Available at: clinicaltrials.gov/study/NCT05923099. Accessed September 2025. Bangert C, et al. Presented at European Academy of Dermatology & Venereology (EADV) 2024 Annual Meeting, Amsterdam, 25–28 September 2024. Thaçi D, et al. Presented at American Academy of Dermatology (AAD) 2023 Annual Meeting, New Orleans, 17–21 March 2023. Thaçi D, et al. Presented at European Academy of Dermatology and Venereology (EADV) 2023 Annual Meeting, Berlin, 11–13 October 2023. Weidinger S, et al. Lancet 2016;387:1109–1122. Boguniewicz M, et al. Immunol Rev 2011;242:233–246. Tubau C, Puig L. Immunotherapy 2021;13:327–344. Bieber T. Allergy 2020;75:54–62. Gittler JK, et al. J Allergy Clin Immunol 2012;130:1344–1354. Nograles K, et al. J Allergy Clin Immunol 2009;123:1244–1252. MAT- 85573 September 2025

Clinical ResultPhase 2License out/in

17 Sep 2025

·endpoints.news

Leo Pharma details mid-stage win for IL-22 targeting antibody in atopic dermatitis

Months after Leo Pharma said its drug candidate for atopic dermatitis delivered positive results in a Phase 2b trial, the company finally revealed details of its success. The highest three doses of the company’s temtokibart significantly improved patients’ Eczema Area and Severity Index (EASI) score from baseline at 16 weeks versus placebo in the study’s primary endpoint, according to results presented Wednesday at the European Academy of Dermatology and Venereology’s annual meeting in Paris. In the highest 600 mg dose cohort, the average EASI score improved about 62% compared with 42% for placebo. Meanwhile, the 450 mg dose led to a 57% improvement in the score. But patients who received the 300 mg dose did best, achieving an average 64% reduction in the same metric. Further, those treated with the 600 mg and 300 mg doses of temtokibart maintained significant improvements in their scores up to 32 weeks, even though they stopped receiving treatment at around 14 weeks. The Phase 2b trial enrolled 262 adults with moderate-to-severe eczema. Although Leo said the trial was positive in May, this is the first time the company reported data. Chief scientific officer Jacob Pontoppidan Thyssen told Endpoints News in an interview that Leo is currently evaluating the best temtokibart dose to advance into a potential Phase 3 study. The company believes the drug’s safety profile could differentiate it from Sanofi and Regeneron’s blockbuster Dupixent. Temtokibart was generally well tolerated in the Phase 2b, with fewer discontinuations or withdrawals due to side effects (2.4%) compared with the placebo group (3.8%). “We did not see conjunctivitis, which you see with Dupixent,” Thyssen said. “We did not see vomiting or nausea to a high degree, or acne, which has been associated with JAK inhibitor use,” he added. Temtokibart works by blocking a subunit of the IL-22 receptor called IL-22RA1. This inhibits the effect of several inflammatory cytokines, including IL-22, IL-20 and IL-24, according to Leo. IL-22 receptors are only found on a type of skin cell called keratinocytes, Thyssen said. “We do not target or hit any of the immune cells, and that’s why we see such a beautiful safety profile at this point.” Dupixent, which targets the IL-4 and IL-13 cytokines, has dominated the atopic dermatitis market to date. The drug reached €3.8 billion ($4.5 billion) in second-quarter sales. But not all patients respond well to the treatment, Thyssen said. Pfizer also tried to develop an IL-22 antibody called fezakinumab, but it failed a mid-stage trial in atopic dermatitis. Fezakinumab targets the free cytokine, whereas temtokibart acts on the receptor, Thyssen said. “What we’ve shown [with the Phase 2b data] is that when you target the receptor, you actually get very good efficacy, which is meaningful for patients,” he added. Leo obtained exclusive rights to temtokibart from Dutch drugmaker argenx in 2022. The partners had previously developed the drug together as part of an exclusive option and research agreement. Editor’s note: This article was updated to clarify that Leo Pharma is headquartered in Denmark.

Clinical ResultPhase 2License out/in

09 May 2025

·pipelinereview.com

LEO Pharma announces Positive Topline Phase 2b Results for Temtokibart in Moderate-to-Severe Atopic Dermatitis

BALLERUP, Denmark I May 09, 2025 I LEO Pharma A/S, a global leader in medical dermatology, today announced positive topline results of the phase 2b trial with temtokibart, an investigational IL-22RA1 antagonist, for the potential treatment of adults with moderate-to-severe atopic dermatitis (AD). The study was a phase 2b, randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose-finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart, also called LEO 138559, in adult subjects with moderate-to-severe AD. 1 The phase 2b trial achieved positive results for the primary endpoint based on percentage change in EASI (Eczema Area and Severity Index) from baseline to Week 16 for 3 highest doses in adults with moderate-to-severe AD. The treatment was generally well-tolerated, with no dose dependency, and the majority of adverse events observed were non-serious, mild or moderate in severity, and not considered treatment related. “ Atopic dermatitis is a complex immunological condition, and patients living with this debilitating disease still face unmet needs. LEO Pharma is committed to making a fundamental difference for these patients, and we are encouraged by the results of this phase 2b trial, which has explored how to target the disease from a different angle with a different mechanism of action, compared to what is commonly used today to treat AD ,” said Dr Jacob Pontoppidan Thyssen, Chief Scientific Officer & Executive Vice President, Science, Search & Innovation at LEO Pharma. “ These results further add to the understanding of the mode of action of temtokibart and its potential abilities to address unmet needs in diseases where the IL-22 pathway is known to play a key role – in medical dermatology and beyond.” Temtokibart is an investigational monoclonal antibody for the treatment of moderate-to-severe AD, which blocks the IL-22RA1 receptor subunit thereby inhibiting the effect of the interleukin-22 (IL-22) cytokine – known to be elevated in patients with atopic dermatitis. 2-4 LEO Pharma and argenx, a global immunology company, formed a strategic alliance in 2015 to develop innovative antibody-based solutions for the treatment of chronic inflammation that underlies many skin conditions. LEO Pharma and argenx jointly developed temtokibart under this research agreement and LEO Pharma has subsequently obtained the exclusive license to develop and commercialize temtokibart. LEO Pharma is currently collecting and evaluating the full data set. Detailed results from the phase 2b trial are planned to be submitted for scientific presentation and publication at a later date. For more information on the trial (NCT05923099) go to clinicaltrials.gov . About the Phase 2b trial The temtokibart phase 2b trial (NCT05923099) is a randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered temtokibart in adult patients with moderate-to-severe atopic dermatitits. 1 Patients were randomized to receive one of four doses of temtokibart or placebo. 1 The primary endpoint is percent change in EASI from baseline to Week 16. 1 The key secondary endpoint is number of treatment-emergent adverse events from baseline to Week 16 per subject. 1 About atopic dermatitis Atopic dermatitis is a chronic, inflammatory skin disease characterized by intense itch and eczematous lesions. 5 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation. 6 Type 2 cytokines, including IL-13, play an important role in the key aspects of atopic dermatitis pathophysiology. 7,8 Excessive IL-22 production is also known to contribute to the pathogenesis of AD. 9,10 About investigational temtokibart Temtokibart is an investigational monoclonal antibody that targets the IL-22RA1 receptor subunit, currently in phase 2 development for the potential treatment of moderate-to-severe atopic dermatitis. 3,4 It blocks the IL-22RA1 subunit and thereby inhibits the effects of the IL-22 cytokine, and also the effects of IL-20 and IL-24 signaling. 3,4 Temtokibart does not bind to the IL-22 cytokine itself. 3,4 LEO Pharma has obtained a worldwide exclusive license to develop and commercialize temtokibart from argenx. About LEO Pharma LEO Pharma is a global leader in medical dermatology. We deliver innovative solutions for skin health, building on a century of experience with breakthrough medicines in healthcare. We are committed to making a fundamental difference in people’s lives, and our broad portfolio of treatments serves close to 100 million patients in over 70 countries annually. Headquartered in Denmark, LEO Pharma has a team of 4,000 people worldwide. LEO Pharma is co-owned by majority shareholder the LEO Foundation and, since 2021, Nordic Capital. For more information, visit www.leo-pharma.com . References SOURCE: LEO Pharma

Phase 2License out/inClinical Result

100 Deals associated with Temtokibart

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dermatitis, Atopic	Phase 2	United States	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	Japan	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	Canada	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	Czechia	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	France	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	Germany	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	Hungary	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	Poland	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	Romania	LEO Pharma A/S	06 Nov 2023
Dermatitis, Atopic	Phase 2	Spain	LEO Pharma A/S	06 Nov 2023

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05923099 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	262	LEO 138559 (Dose Regimen 1)	mlcfnuiktk(hxkalxocqm) = pqekoxrdfm hnipsuxlst (ustqnzyoil, yzgttsndxi - xuqvurqqch) View more	-	12 Feb 2026
				LEO 138559 (Dose Regimen 2)	mlcfnuiktk(hxkalxocqm) = zgdjdtadmy hnipsuxlst (ustqnzyoil, sxhkbvsdqw - htwyvlicus) View more
NCT05923099 (BusinessWire) Manual	Phase 2	Dermatitis, Atopic	-	Temtokibart	lfqzyqseac(qhzulhsyxy) = achieved positive results for the primary endpoint. yfcoutaueo (ndrsaypofz ) View more	Positive	09 May 2025
				Placebo
NCT05470114 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	13	LEO 138559 (LEO 138559)	kzdwwmaqrr(ujvwloiibn) = srwayevkno hxribmxjsp (glwimtpled, 7.692) View more	-	14 Feb 2025
				Dupixent® (Dupixent®)	kzdwwmaqrr(ujvwloiibn) = oewkmbuwkq hxribmxjsp (glwimtpled, 8.899) View more
NCT05470114 (PipelineReview) Manual	Phase 2	Dermatitis, Atopic	12	temtokibart	qpxryujfqx(ljpvjhxeoa): P-Value = <0.0001 View more	Positive	30 Sep 2024
				dupilumab
NCT04922021 (EADV2023)	Phase 2	Moderate Atopic Dermatitis	-	LEO 138559	iiawxuelfk(gavoojgofc) = jijwiweouf gzbipuslch (qegqkbxnwd ) View more	Positive	11 Oct 2023
				Placebo	wkihudlbxy(jniryvgiqd) = bvmahnzgjh gmzakmirtr (skyrvpcdkz ) View more
NCT04922021 (CTgov)	Phase 2	Moderate Atopic Dermatitis \| Severe Atopic Dermatitis	58	LEO 138559 (LEO 138559)	gcslheqrwv(xpeeuhnang) = xyvrjdeneq iqqtcwrupb (cncoirhkry, 2.64) View more	-	24 Jul 2023
				LEO 138559 placebo (Placebo)	gcslheqrwv(xpeeuhnang) = zvnrjdoyfx iqqtcwrupb (cncoirhkry, 2.91) View more

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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