A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

Start Date14 Apr 2022

Sponsor / Collaborator

Vanda Pharmaceuticals, Inc.

ACTRN12617000369325

/ CompletedPhase 1

A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANB019 in Healthy Subjects and Psoriasis Patients.

Start Date03 Apr 2017

Sponsor / Collaborator

AnaptysBio Pty Ltd.

[+1]

100 Clinical Results associated with Imsidolimab

100 Translational Medicine associated with Imsidolimab

100 Patents (Medical) associated with Imsidolimab

Literatures (Medical) associated with Imsidolimab

01 May 2024·American journal of clinical dermatology

Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis

Review

Author: Wu, Po-Chien ; Huang, Yu-Huei ; Huang, I-Hsin ; Chiu, Hsien-Yi

BACKGROUND:

The comparative efficacy of biologics and small-molecule inhibitors in treating palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP) remains uncertain.

OBJECTIVE:

The aim was to perform a systematic review and network meta-analysis (NMA) to compare the efficacy of biologics and small-molecule inhibitors for the treatment of PP and PPP.

METHODS:

MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched for eligible studies from inception to May 13, 2023. This NMA was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension Statement for Network Meta-Analyses guidelines. Frequentist random-effects models NMA was performed with the surface under the cumulative ranking curve calculated for ranking. Our primary outcome was the proportion of patients achieving a clear/minimal Palmoplantar Psoriasis/Pustulosis Physician Global Assessment score (PPPGA 0/1 or PPPPGA 0/1) response at 12-16 weeks. Secondary outcomes consisted of the percentage of overall improvement in palmoplantar score and of improvement ≥ 75%, at 12-16 weeks.

RESULTS:

The study comprised a total of 29 randomized controlled trials (RCTs), involving 4798 psoriasis patients with palmoplantar diseases. For PP, 16 RCTs with nine different treatments, including adalimumab, apremilast, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab were included for the analysis. In the NMA of PP, secukinumab 300 mg ranked highest (odds ratio [OR] 33.50, 95% confidence interval [CI] 4.37-256.86) in achieving PPPGA 0/1, followed by guselkumab 100 mg (OR 18.68, 95% CI 10.07-34.65). In the case of PPP, seven RCTs with six treatments, including apremilast, etanercept, guselkumab, imsidolimab, spesolimab, and ustekinumab, were included for the analysis. In the NMA of PPP, although no treatment demonstrated a significant difference compared to placebo in achieving PPPPGA 0/1, guselkumab 100 mg showed the greatest statistically significant improvement in the palmoplantar score (weighted mean difference 31.73, 95% CI 19.89-43.57) as a secondary outcome.

CONCLUSION:

Among all available biologics and small-molecule inhibitors, secukinumab 300 mg and guselkumab 100 mg had the most favorable efficacy in treating PP and PPP, respectively.

17 Jul 2023·The British journal of dermatology

Imsidolimab: an emerging biological therapy for generalized pustular psoriasis.

Communications

Author: Gleeson, David ; Mahil, Satveer K

17 Jul 2023·The British journal of dermatology

Imsidolimab, an anti-interleukin-36 receptor monoclonal antibody, for the treatment of generalized pustular psoriasis: results from the phase II GALLOP trial

Article

Author: Placek, Waldemar ; Zhou, Jihao ; Reich, Adam ; Kaszuba, Andrzej ; Warren, Richard B ; Gudjonsson, Johann E ; Griffiths, Christopher E M ; Randazzo, Bruce ; Lizzul, Paul

Abstract:

Background:

Generalized pustular psoriasis (GPP) is a systemic inflammatory disease that can be severe, debilitating and life threatening. Uncontrolled activation of interleukin (IL)-36 proinflammatory activity may underlie the pathogenesis of GPP. Currently, GPP-specific treatment options are limited.

Objectives:

To evaluate the efficacy and safety of the anti-IL-36 receptor antibody imsidolimab in patients with GPP.

Methods:

In an open-label, single-arm, multiple-dose study, patients with GPP were treated with imsidolimab to assess clinical efficacy, tolerability and safety. Patients received an intravenous dose of imsidolimab 750 mg on day 1, followed by three subcutaneous doses of imsidolimab 100 mg administered on days 29, 57 and 85. The primary efficacy endpoint was the proportion of patients who achieved a clinical response at weeks 4 and 16 following treatment with imsidolimab, as measured by the Clinical Global Impression scale.

Results:

Eight patients were enrolled and six completed the study. Responses were observed as early as day 3, most rapidly for pustulation relative to other manifestations of GPP, with continued and consistent improvement across multiple efficacy assessments at day 8, day 29 and through day 113. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. No patient discontinued the study owing to a nonserious TEAE. Two patients experienced serious adverse events (SAEs); no deaths were reported.

Conclusions:

Imsidolimab demonstrated a rapid and sustained resolution of symptoms and pustular eruptions in patients with GPP. It was generally well tolerated, with an acceptable safety profile, and is advancing to phase III trials. These data support the targeting of IL-36 signalling with a specific antibody – imsidolimab – as a therapeutic option for this severely debilitating condition.

News (Medical) associated with Imsidolimab

14 Oct 2025

·www.globenewswire.com

Anaptys Announces Late-Breaking Oral Presentation of Complete Phase 2b Data for Rosnilimab in Rheumatoid Arthritis at Upcoming ACR Convergence 2025

Oct. 13, 2025 -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that complete data from the Phase 2b trial of rosnilimab, a pathogenic T cell depleter, in rheumatoid arthritis (RA), was accepted for a late-breaking oral presentation at American College of Rheumatology (ACR) Convergence 2025 in Chicago, IL, Oct. 24 – 29, 2025. “We are honored to be selected by ACR to present our late-breaking Phase 2b data for rosnilimab in RA,” said Paul Lizzul, chief medical officer of Anaptys. “Being selected reinforces the transformational potential of rosnilimab, which delivered a compelling safety and tolerability profile and JAK-like efficacy through six months that was durable for at least three months off-drug. We look forward to Professor Emery’s presentation later this month.” Abstract Title – Rosnilimab, a Selective and Potent Depleter of Pathogenic T Cells, Demonstrates Efficacy, Safety, and Translational Proof of Mechanism in a Rheumatoid Arthritis Phase 2b Trial Abstract ID - 2215555 Session Date and Time - Wednesday, Oct. 29 from 8:00am – 9:30am CT Paul Emery, M.D., professor, Rheumatology, University of Leeds, Leeds Biomedical Research Centre, U.K., will be the presenting author. The presentation will be available for download on the Anaptys website after the session here. Rosnilimab is a novel therapeutic antibody that directly targets pathogenic T cells, such as activated Tph/Tfh and T effector cells, in the periphery or inflamed tissue. When activated, these T cells proliferate and migrate and secrete inflammatory cytokines that are the drivers of autoimmune and inflammatory diseases. Rosnilimab is designed to selectively and potently deplete pathogenic T cells in both inflamed tissue and the periphery while sparing nonpathogenic T cells, including naïve T cells, to preserve overall immune function and restore immune homeostasis. This drives specific immunological outcomes, such as a reduction in T cell proliferation, migration and cytokine secretion, and a reduction of plasma cell generation and autoantibody levels. Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases. Its lead program, rosnilimab, a pathogenic T cell depleter, completed a Phase 2b trial for the treatment of rheumatoid arthritis and is in a Phase 2 trial for the treatment of ulcerative colitis. The company’s pipeline also includes ANB033, a CD122 antagonist, being studied in celiac disease and ANB101, a BDCA2 modulator, both in Phase 1 trials. Anaptys has also discovered and out-licensed in financial collaborations multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli (dostarlimab-gxly)) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals. To learn more, visit www.AnaptysBio.com or follow us on LinkedIn. Anaptys recently announced the intent to separate its biopharma operations from its substantial royalty assets by year-end 2026, enabling investors to align their investment philosophies and portfolio allocation with the strategic opportunities and financial objectives of each company. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyClinical Result

01 Oct 2025

·www.biospace.com

AnaptysBio Plans Business Split To Sharpen Focus on Asset Value

iStock, SvetaZi The business separation, expected to be completed by the end of 2026, will result in two new companies, one focused on biopharma operations and the other on royalty management. AnaptysBio will split its current business into two publicly traded entities: one focused on biopharma operations, including advancing the original company’s clinical pipeline, and the other on royalty management. The business separation, according to analysts at Leerink Partners, will help AnaptysBio crystallize the value of its royalties and highlight the worth of its other assets. “We believe this separation will sharpen investor focus on the company’s asset values by distinguishing between a royalty-backed cash flow vehicle and a clinical-stage pipeline company,” the analysts wrote in an investor note on Tuesday. After the split, much of the work of the royalty-focused company will revolve around Jemperli , GSK’s PD-1 blocker indicated for endometrial cancer and solid tumors. Jemperli was discovered by AnaptysBio, which licensed it out to TESARO in March 2014 under a worldwide immuno-oncology antibody partnership. GSK acquired TESARO in December 2018 for $5.1 billion . According to AnaptysBio’s Tuesday release, GSK has maintained a guidance of around $2.7 billion in peak Jemperli sales and has continued to assess the drug in other indications, including rectal cancer, colon cancer and head-and-neck squamous cell carcinoma. The royalty arrangement over Jemperli will extend “at least through expiration” of related patents, according to AnaptysBio’s statement. The royalty entity will also manage payments from Vanda Pharmaceuticals for the IL-36 receptor inhibitor imsidolimab, being developed for generalized pustular psoriasis under a February 2025 contract . This new royalty spinout will be eligible for $35 million in milestone payments plus a 10% royalty on net sales, according to AnaptysBio. Meanwhile, the resulting biopharma company will be dedicated to the development of its CD122 antagonist ANB033, being tested in a Phase Ib trial for celiac disease, and the BDCA2 modulator ANB101, which is currently being studied in healthy volunteers in a Phase Ia trial. At its launch, this new biopharma spinout will have enough money to keep it running for “at least two years,” the release stated. Leading this new entity’s pipeline is the T cell depleter rosnilimab, which in May this year cleared the Phase IIb RENOIR study in rheumatoid arthritis. The asset is currently in a Phase IIb trial of ulcerative colitis, with data expected by the end of the year. AnaptysBio is currently reviewing its strategic options for rosnilimab, the company said on Tuesday, the results of which will determine how the value of the asset will be allocated between the two companies. AnaptysBio has yet to disclose names for these two new entities, though current CEO Daniel Faga will lead the biopharma spinout. The company expects to complete this business split by the end of 2026.

Phase 2Phase 1AcquisitionDrug ApprovalLicense out/in

30 Sep 2025

·endpoints.news

AnaptysBio plans to split its pipeline from its royalty assets into two publicly traded companies

AnaptysBio wants to split into two companies to see if its pipeline and royalty assets will get more appreciation from investors if they stand alone. The San Diego biotech said Monday that it will start by exploring separating its business into two publicly traded companies. With three clinical-stage assets, including one on the verge of Phase 3, the company will need hefty funds to advance those experimental medicines. The company’s lead drug, a T cell depleter known as rosnilimab, is slated to have a Phase 2 readout in ulcerative colitis by the end of the year. AnaptysBio wants to find a global partner for the drug in UC, rheumatoid arthritis and other indications, though it can take the drug into Phase 3 in UC on its own. “Management was clear that the move was in no way a reflection on their confidence in the topline data readout of rosnilimab in UC,” TD Cowen analysts wrote in a Monday note. AnaptysBio’s pipeline also contains a CD122 antagonist called ANB033 that is in Phase 1b for celiac disease and is set to enter studies for inflammatory disease next year. A healthy volunteer trial is currently assessing the BDCA2 modulator known as ANB101 in inflammatory disease. Meanwhile, AnaptysBio wants to unlock the full value of its royalties at a time when the royalty business has picked up steam . The company receives royalties from GSK via their cancer drug Jemperli. AnaptysBio currently transfers the royalties from GSK to the royalty aggregator Sagard. Once Sagard gets $600 million from the royalty arrangement, AnaptysBio no longer has to fork over the royalties. The biotech anticipates that will happen between mid-2027 and the second quarter of 2028. GSK continues to test Jemperli in additional indications, meaning its sales could go up in the future and provide more royalties for AnaptysBio. The drug racked up £196 million (about $260 million) in revenue in the second quarter of this year. AnaptysBio also hopes to get milestone payments and royalties from Vanda regarding imsidolimab. The drug failed a trio of trials in 2021 and 2022 , leading to the AnaptysBio CEO’s resignation , but eventually cleared a Phase 3 in a rare form of psoriasis in 2023. The drug was transferred to Vanda, which is expected to submit an application to the FDA in the second half of this year. An approval in the US would trigger a $5 million milestone for AnaptysBio, up to another $30 million in milestones, and 10% royalty on sales.

Phase 3Phase 2Drug ApprovalPhase 1Accelerated Approval

100 Deals associated with Imsidolimab

External Link

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D11892	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Generalized Pustular Psoriasis	Phase 3	China	Ppc China Corp. Ltd.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	China	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Australia	Ppc China Corp. Ltd.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Australia	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Malaysia	Ppc China Corp. Ltd.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Malaysia	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	South Korea	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	South Korea	Ppc China Corp. Ltd.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Taiwan Province	AnaptysBio, Inc.	25 May 2023
Generalized Pustular Psoriasis	Phase 3	Taiwan Province	Ppc China Corp. Ltd.	25 May 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05352893 (GEMINI1, GlobeNewswire) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab 750mg (GEMINI-1)	iftycthans(vqfgrlekrj) = xgfrpzbgki krxqskysmg (igfjdfumdz )	Positive	09 May 2024
				Imsidolimab 300mg (GEMINI-1)	iftycthans(vqfgrlekrj) = bsprrrgizm krxqskysmg (igfjdfumdz )
NCT05352893 (GEMINI1, Corporate Publications) Manual	Phase 3	Generalized Pustular Psoriasis	45	Imsidolimab	xaqlzstluf(ihpbmocggh) = tuncaadpks fzqogjrsnh (ehyvjeknjq ) Met View more	Positive	09 Oct 2023
				Placebo	xaqlzstluf(ihpbmocggh) = invvtrhttf fzqogjrsnh (ehyvjeknjq ) Met

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