A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease

Primary objective of the study is to evaluate the effect of abiprubart on an established systemic disease activity measure for Sjögren's Disease.

Start Date17 Jul 2024

Sponsor / Collaborator

Kiniksa Pharmaceuticals International Plc

[+1]

NCT05198310

/ CompletedPhase 2

A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of KPL-404 in Subjects With Moderate to Severe Active Rheumatoid Arthritis With Inadequate Response or Intolerance to at Least One Biologic Disease-modifying Anti-rheumatic Drug or a Janus Kinase Inhibitor

Phase 2 study of the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of KPL-404 in subjects with moderate to severe Rheumatoid Arthritis.

Start Date14 Dec 2021

Sponsor / Collaborator

Kiniksa Pharmaceuticals Ltd.

NCT04497662

/ CompletedPhase 1

A Phase 1 First-in-human Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of KPL-404 in Healthy Subjects

Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects

Start Date22 Oct 2019

Sponsor / Collaborator

Kiniksa Pharmaceuticals Ltd.

100 Clinical Results associated with Abiprubart

100 Translational Medicine associated with Abiprubart

100 Patents (Medical) associated with Abiprubart

Literatures (Medical) associated with Abiprubart

01 Dec 2023·The Journal of pharmacology and experimental therapeutics

First-in-Human Phase 1 Randomized Trial with the Anti-CD40 Monoclonal Antibody KPL-404: Safety, Tolerability, Receptor Occupancy, and Suppression of T-Cell–Dependent Antibody Response

Article

Author: Ziemniak, John ; Samant, Manoj ; Paolini, John F

Blockade of the cluster of differentiation 40 (CD40)-CD40L interaction has potential for treating autoimmune diseases and preventing graft rejection. This first-in-human, randomized, double-blind, placebo-controlled study (NCT04497662) evaluated safety, pharmacokinetics, receptor occupancy, and pharmacodynamics of the humanized anti-CD40 monoclonal antibody KPL-404. Healthy volunteers were randomized to one of two single-ascending-dose groups: single intravenous KPL-404 dose 0.03, 0.3, 1, 3, or 10 mg/kg or single subcutaneous KPL-404 dose 1 or 5 mg/kg. There were no dose-limiting or dose-related safety findings. Nonlinear dose-dependent changes in various pharmacokinetic parameters were identified following the range of intravenous doses. At the 10 mg/kg intravenous dose level, the t_1/2 was approximately 7 days, and full receptor occupancy was observed through Day 71, with complete suppression of T-cell-dependent antibody response (TDAR) to keyhole limpet hemocyanin (KLH) challenge on Day 1 and rechallenge on Day 29 through Day 57. With KPL-404 5 mg/kg subcutaneously, full receptor occupancy was observed through Day 43, with complete suppression of TDAR through at least Day 29. Antidrug antibodies to KPL-404 were suppressed for 57 days with 10 mg/kg intravenously and for 50 days with 5 mg/kg subcutaneously, further confirming prolonged target engagement and pharmacodynamics. These findings support continued investigation of KPL-404 intravenous and subcutaneous administration in a broad range of indications. SIGNIFICANCE STATEMENT: This first-in-human clinical trial of KPL-404, a fully humanized IgG4 monoclonal antibody, was designed with two independent (by route of administration) placebo-controlled single-ascending-dose-level groups, one with four intravenous single-dose cohorts and another with two subcutaneous single-dose cohorts. The pharmacokinetic profile, duration of full CD40 receptor occupancy, and magnitude and duration of memory immune response suppression observed confirm pharmacodynamic activity regardless of administration route. These data provide evidence that chronic KPL-404 dosing regimens (intravenous or subcutaneous) could be practical.

01 Apr 2022·The Journal of pharmacology and experimental therapeuticsQ3 · MEDICINE

Preclinical Immunopharmacologic Assessment of KPL-404, a Novel, Humanized, Non-Depleting Antagonistic Anti-CD40 Monoclonal Antibody

Q3 · MEDICINE

Article

Author: Muralidharan, Sujatha ; Garron, Tracy ; Njenga, Moses ; Paolini, John F ; Bondensgaard, Kent

The CD40/CD40L pathway plays a major role in multiple inflammatory processes involving different immune and stromal cells. Abnormal activation of this pathway has been implicated in pathogenesis of complex autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, Graves' disease, and Sjogren's Syndrome. We completed in vitro and in vivo preclinical characterization of KPL-404, a novel humanized anti-CD40 IgG4 monoclonal antibody, to demonstrate its potency, efficacy, and pharmacokinetic profile; safety was also assessed. In vitro, KPL-404 bound recombinant human and cynomolgus monkey CD40 with comparable affinity in the nanomolar range. KPL-404 binding to cell surface CD40 did not induce antibody- or complement-mediated cytotoxicity of CD40-expressing cells. Pharmacological antagonistic activity of KPL-404 was demonstrated in vitro by inhibition of CD40-mediated downstream NF-kB activation. In the in vivo study with cynomolgus monkeys, KPL-404, administered intravenously as a single dose (10 mg/kg) or two monthly doses of 1 or 5 mg/kg, did not elicit observable safety findings, including thrombocytopenia over 8 weeks. KPL-404 engaged CD40 expressed on peripheral B cells for 2 and 4 weeks after a single administration of 5 or 10 mg/kg IV, respectively, without depletion of peripheral B cells. At 5 mg/kg IV, KPL-404 blocked both primary and secondary responses to T-cell dependent antibody responses to test antigens, KLH, and tetanus toxoid. These data illustrated the relationship between KPL-404 serum concentration and pharmacodynamic effects of CD40-targeting in circulation and in lymphoid tissues. These data support clinical development of KPL-404 in autoimmune diseases. SIGNIFICANCE STATEMENT: We aimed to develop a potent and efficacious CD40 antagonist. In vitro and in vivo findings show that KPL-404 blocks the anti-CD40 antibody that potently inhibits primary and secondary antibody responses at pharmacologically relevant concentrations, has a favorable pharmacokinetic profile, and does not deplete B cells by antibody-dependent cellular cytotoxicity or apoptosis ("nondepleting"). These findings support clinical development of KPL-404 as a potential therapeutic in autoimmune diseases.

01 Dec 2021·Arthritis research & therapy

Correction to: Anti-CD40 antibody KPL-404 inhibits T cell-mediated activation of B cells from healthy donors and autoimmune patients

Author: Giltiay, Natalia V ; Marken, John ; Muralidharan, Sujatha

An amendment to this paper has been published and can be accessed via the original article.

News (Medical) associated with Abiprubart

26 Feb 2025

·www.biospace.com

Kiniksa Axes Sjögren’s Program, AstraZeneca-Licensed Antibody in Cardio Pivot

iStock, cagkansayin Kiniksa will now focus its development efforts on the IL-1 blocker KPL-387, which it is testing for recurrent pericarditis with Phase II/III trials planned for mid-2025. Kiniksa Pharmaceuticals will no longer move forward with its Sjögren’s syndrome drug development program and will walk away from an investigational antibody licensed from AstraZeneca, the London-based biotech announced on Tuesday. In Sjögren’s, Kiniksa was testing abiprubart, a monoclonal antibody that targets the CD40 protein, which is highly expressed in specific types of immune cells. In autoimmune diseases such as Sjögren’s, this mode of action could potentially disrupt pathological pathways that would otherwise culminate in a defective immune response that attacks healthy cells. Before being shelved, abiprubart was one of Kiniksa’s most mature assets. In July 2024, the biotech kicked off its Phase IIb study for the asset, testing biweekly and monthly dosing schedules in approximately 200 patients. The decision to discontinue abiprubart is in line with Kiniksa’s “strategic reprioritization of its portfolio and certain capital allocation considerations,” the biotech wrote in an SEC filing dated Feb. 21. The company will “immediately” stop enrollment into abiprubart’s mid-stage study and start winding down activities linked to the asset, while looking for strategic alternatives. Abiprubart’s termination has already cost Kiniksa $19 million, and the biotech expects to incur around $14 million to $17 million more in discontinuation expenses, mostly attributed to “contract termination costs” for existing supply agreements. Kiniksa expects to wrap up wind-down activities for abiprubart by the end of the year. Other players in the Sjögren’s syndrome space include J&J and Horizon Therapeutics , which reported respective mid-stage wins in June 2024 and January 2023. Also on Tuesday, Kiniksa announced it is terminating its licensing deal with AstraZeneca’s MedImmune for the GM-CSF blocker mavrilimumab. The asset, also a monoclonal antibody, was being tested for the chronic autoimmune disease giant cell arteritis and COVID-19-related acute respiratory distress syndrome. Kiniksa entered its licensing deal with MedImmune in December 2017, paying $23 million in upfront, pass-through and certain clinical milestone payments. At the time, the London biotech also promised up to $57.5 million in future milestones for the first two programs covered by the contract, plus up to $15 million for additional indications. In January 2024, however, Kiniksa announced it had slowed down investment into mavrilimumab and was in the process of looking for potential development partners for the asset. With abiprubart and mavrilimumab discontinued, Kiniksa is down to a completely cardiovascular pipeline —though the indication for its most immature candidate, the IL-1 antagonist KPL-1161, has yet to be disclosed. As per its Tuesday press release, Kiniksa will now focus its development efforts on KPL-387, also an IL-1 blocker, for recurrent pericarditis. The biotech is gearing up for a Phase II/III trial of the asset in mid-2025.

License out/inPhase 2Phase 1

25 Feb 2025

·www.fiercebiotech.com

Kiniksa adds to Sjögren\'s exodus with trial termination, axes AstraZeneca asset

In the wake of its recent pipeline decisions, Kiniksa is evaluating strategic alternatives for abiprubart.\n Kiniksa Pharmaceuticals is stopping development of a midphase autoimmune asset and returning a drug candidate to AstraZeneca as it doubles down on its cardiovascular disease pipeline.The asset licensed from AstraZeneca, GM-CSF antagonist mavrilimumab, was already on the back-burner, but the termination of the midphase autoimmune program comes as more of a shock. Six weeks ago, Kiniksa chief medical officer John Paolini, M.D., told investors the company was “certainly very excited” about a phase 2b trial of abiprubart in Sjögren’s syndrome. Today, Kiniksa said it is stopping the study.Kiniksa, which is evaluating strategic alternatives for abiprubart, framed the decision to end the trial as a result of a “strategic reprioritization of its portfolio and certain capital allocation considerations.” The action will cost $33 million to $37 million, Kiniksa said, but will free the biotech from the cost of funding a study that was scheduled to run into 2027.Abiprubart, an antibody that inhibits the signaling between CD40 and CD154, was in development in a competitive niche but Kiniksa had previously presented that as a positive. Last month, Kiniksa CEO Sanj Patel told investors “there has been some external derisking of the mechanism through other assets,” but he said abiprubart was differentiated through its monthly subcutaneous dosing.Amgen’s CD40L antagonist fusion protein, dazodalibep, is ahead of abiprubart in the race to market, with the big biotech starting phase 3 trials in Sjögren’s last year. But that drug is given intravenously.The high-concentration liquid formulation of abiprubart opened up the option of subcutaneous dosing. The list of rivals that Kiniksa believed may be able to offer subcutaneous dosing has thinned in recent years. Novartis axed its rival subcutaneous anti-CD40 antibody in Sjögren’s last month after assessing the risks and benefits of the molecule. Sanofi reached a similar decision in April, when it crossed Sjögren’s off the list of potential indications for its anti-CD40L prospect. Bristol Myers Squibb terminated a phase 1 trial of its CD40 candidate in Sjögren’s in 2023 because of “insufficient enrollment.” Kiniksa disclosed the winddown of its Sjögren’s trial, which it expects to complete by the end of the year, alongside the news that it is terminating development of mavrilimumab. The biotech licensed the asset from AstraZeneca’s MedImmune in 2017, paying $23 million in upfront and subsequent payments. But by early last year, the company was evaluating potential partnership opportunities to advance the molecule.The hunt for a partner ended last week, when Kiniksa told MedImmune it was stopping development of the asset and terminating the license agreement. Kiniksa’s actions leave it focused on a cardiovascular disease pipeline led by the IL-1 antagonist KPL-387. The program is targeting recurrent pericarditis, the same indication as Kiniksa’s approved drug Arcalyst, and a phase 2/3 trial is set to start this year.

License out/inPhase 2Phase 3Clinical Trial Termination

25 Feb 2025

·investors.kiniksa.com

Kiniksa Pharmaceuticals Announces Development of KPL-387 in Recurrent Pericarditis and Updates Corporate Strategy

– Kiniksa plans to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025 – – KPL-387 Phase 1 single ascending dose data support potential monthly dosing – – Kiniksa continues to focus development on diseases with unmet need, prioritizing cardiovascular indications – – Kiniksa to discontinue abiprubart development in Sjögren’s Disease – LONDON, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today announced the development program for KPL-387 in recurrent pericarditis and provided an update on its corporate strategy. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines interleukin-1α (IL-1α) and interleukin-1β (IL-1β). “Through the successful development and commercialization of ARCALYST, Kiniksa has helped thousands of patients suffering from recurrent pericarditis. Since the launch in 2021, we have generated over $800 million in product revenue and have become cash flow positive on an annual basis. We plan to further increase our penetration into the recurrent pericarditis population with ARCALYST,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “We also continue to focus development on novel therapies for diseases with unmet need, prioritizing cardiovascular indications. Today, we are excited to extend our leadership in the recurrent pericarditis market through the development of KPL-387. We believe KPL-387 could expand the treatment options for recurrent pericarditis patients by providing a single monthly subcutaneous injection in a liquid formulation.” “KPL-387 could provide a meaningful addition to the therapeutic options available to patients suffering from recurrent pericarditis. Data generated from the single ascending dose portion of the ongoing Phase 1 study support our belief that KPL-387 could enable dosing with a single monthly subcutaneous injection in a liquid formulation,” said John F. Paolini, M.D., Ph.D., FACC, Chief Medical Officer of Kiniksa. “We have interacted with the FDA, and we plan to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026.” Corporate Update Kiniksa continues to focus development on diseases with unmet need, prioritizing cardiovascular indications. Kiniksa is developing KPL-387, a fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β, in recurrent pericarditis with a target profile of monthly subcutaneous (SC) dosing. Kiniksa is conducting a single ascending dose (SAD) and multiple ascending dose Phase 1 clinical trial of KPL-387 in healthy volunteers. Topline data from the SAD portion of the Phase 1 trial of KPL-387 support potential monthly SC dosing in recurrent pericarditis. Kiniksa has interacted with the U.S. Food and Drug Administration (FDA) and expects to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026. Kiniksa is advancing KPL-1161, an Fc-modified IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β, towards clinical development with a target profile of quarterly SC dosing. Kiniksa plans to discontinue the development of abiprubart in Sjögren’s Disease. The company will explore strategic alternatives for the asset. Kiniksa has exercised its right to terminate its exclusive license agreement for mavrilimumab with MedImmune. Kiniksa is conducting a single ascending dose (SAD) and multiple ascending dose Phase 1 clinical trial of KPL-387 in healthy volunteers. Topline data from the SAD portion of the Phase 1 trial of KPL-387 support potential monthly SC dosing in recurrent pericarditis. Kiniksa has interacted with the U.S. Food and Drug Administration (FDA) and expects to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026. Topline data from the SAD portion of the Phase 1 trial of KPL-387 support potential monthly SC dosing in recurrent pericarditis. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit www.kiniksa.com. About ARCALYSTARCALYST® (rilonacept) is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and children 12 years and older. ARCALYST is also approved by the FDA for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 years and older, and the maintenance of remission of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and pediatric patients weighing 10 kg or more. The FDA granted Orphan Drug Exclusivity to ARCALYST upon its approval for recurrent pericarditis in 2021. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021. IMPORTANT SAFETY INFORMATION ABOUT ARCALYST ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection). While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection. Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST. Medicines that affect the immune system may increase the risk of getting cancer. Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction. Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides. Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose. For more information about ARCALYST, talk to your doctor and see the Product Information. About KPL-387KPL-387 is an independently developed, investigational, fully human IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β. Kiniksa believes KPL-387 could expand the treatment options for recurrent pericarditis patients by enabling dosing with a single monthly SC injection in a liquid formulation. About KPL-1161KPL-1161 is an independently developed, investigational, Fc-modified IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β, with a target profile of quarterly SC dosing. Kiniksa is currently engaging in IND-enabling development activities for KPL-1161. About AbiprubartAbiprubart is an investigational humanized monoclonal antibody that binds to CD40 and is designed to inhibit the CD40-CD154 (CD40 ligand) interaction, a key T-cell co-stimulatory signal critical for B-cell maturation and immunoglobulin class switching and Type 1 immune responses. Kiniksa believes disrupting the CD40-CD154 co-stimulatory interaction is an attractive approach to addressing multiple autoimmune disease pathologies. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify forward- looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our plan to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026; our plan to discontinue the development of abiprubart in Sjögren’s Disease and explore strategic alternatives for the asset; our plan to prioritize development in cardiovascular indications; our plan to further increase our penetration into the recurrent pericarditis market with ARCALYST; our belief that KPL-387 could expand the treatment options for recurrent pericarditis patients by providing a single monthly SC injection in a liquid formulation; our target profile of monthly and quarterly SC dosing for KPL-387 and KPL-1161, respectively; our beliefs about the mechanisms of our assets and potential impact of their approach; and our belief that our portfolio of assets offers the potential for differentiation. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; business development activities and their impact on our financial performance and strategy; changes in our operating plan, business development strategy or funding requirements; and existing or new competition. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc. Every Second Counts!® Kiniksa Investor ContactJonathan Kirshenbaum(781) 829-3949jkirshenbaum@kiniksa.com Kiniksa Media ContactTyler Gagnon (781) 431-9100tgagnon@kiniksa.com

Phase 1Orphan DrugDrug ApprovalLicense out/in

100 Deals associated with Abiprubart

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Sjogren's Syndrome	Phase 2	-	Kiniksa Pharmaceuticals Ltd.	09 Jul 2024
Rheumatoid Arthritis	Phase 2	United States	Kiniksa Pharmaceuticals Ltd.	14 Dec 2021
Rheumatoid Arthritis	Phase 2	Bulgaria	Kiniksa Pharmaceuticals Ltd.	14 Dec 2021
Rheumatoid Arthritis	Phase 2	Czechia	Kiniksa Pharmaceuticals Ltd.	14 Dec 2021
Rheumatoid Arthritis	Phase 2	Georgia	Kiniksa Pharmaceuticals Ltd.	14 Dec 2021
Rheumatoid Arthritis	Phase 2	Hungary	Kiniksa Pharmaceuticals Ltd.	14 Dec 2021
Rheumatoid Arthritis	Phase 2	Poland	Kiniksa Pharmaceuticals Ltd.	14 Dec 2021
Rheumatoid Arthritis	Phase 2	South Africa	Kiniksa Pharmaceuticals Ltd.	14 Dec 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05198310 (EULAR 12024 \| EULAR 22024) Manual	Phase 2	Rheumatoid Arthritis	78	Abiprubart 5mg/kg SC qwk	nnpybsoyjf(ehzslidwmo) = qckvwoaato mglilzbifu (lyknkvukdj, -2.62 to -1.80)	Positive	12 Jun 2024
				Abiprubart 5mg/kg SC q2wk	nnpybsoyjf(ehzslidwmo) = tmqjfhkhru mglilzbifu (lyknkvukdj, -2.43 to -1.58)
GlobeNewswire Manual	Phase 2	Rheumatoid Arthritis	51	Abiprubart (Cohort 4:400 mg SC monthly dose group)	jjwbfcvrwa(lmqdydlhyr) = wfwljqurbi romyqypwbk (ewahlasrpj, -2.54 to -1.21)	Positive	02 Apr 2024
				Placebo	jjwbfcvrwa(lmqdydlhyr) = uivvytbitu romyqypwbk (ewahlasrpj, -1.98 to -0.62)
GlobeNewswire Manual	Phase 2	Rheumatoid Arthritis	129	Abiprubart (pooled group)	zniwdqvaam(oprccagbpl) = qgdwmgaces mgoodlxvkr (maplhtenkv, -2.34 to -1.74)	Positive	02 Apr 2024
				Placebo	zniwdqvaam(oprccagbpl) = dbcfssdnbd mgoodlxvkr (maplhtenkv, -1.88 to -1.16)
GlobeNewswire Manual	Phase 2	Rheumatoid Arthritis	-	Abiprubart (Cohort 1)	-	Positive	02 Apr 2024
				Abiprubart (Cohort 2)
Biospace Manual	Phase 2	Rheumatoid Arthritis Rheumatoid Factor	-	Abiprubart 2 mg/kg SC biweekly dosing (Cohort 1)	cwesyeaaak(tesfvokcbt) = pxagusvlim dhgdsnzbxs (fgxzhuyykp ) View more	Positive	04 Jan 2024
				Abiprubart 5 mg/kg SC biweekly dosing (Cohort 2)	cwesyeaaak(tesfvokcbt) = cmrpfppldm dhgdsnzbxs (fgxzhuyykp ) View more

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