A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.

Start Date22 Jun 2023

Sponsor / Collaborator

ACELYRIN, Inc.

CTIS2022-501362-22-00 / Not yet recruiting

22104: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis - 22104

Start Date25 Apr 2023

Sponsor / Collaborator

ACELYRIN, Inc.

NCT05623345 / TerminatedPhase 2/3

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Active Psoriatic Arthritis

Izokibep is a potent and selective inhibitor of interleukin (IL)-17A that is being developed for treatment of psoriatic arthritis (PsA).
This study will evaluate the efficacy of izokibep in subjects with PsA.

Start Date21 Nov 2022

Sponsor / Collaborator

ACELYRIN, Inc.

100 Clinical Results associated with Izokibep

100 Translational Medicine associated with Izokibep

100 Patents (Medical) associated with Izokibep

Literatures (Medical) associated with Izokibep

01 Jun 2024·Annals of the rheumatic diseases

Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis

Review

Author: Ferreira, Ricardo J O ; Gossec, Laure ; Esbensen, Bente Appel ; McInnes, Iain B ; Boehncke, Wolf-Henning ; van der Heijde, Désirée ; Kerschbaumer, Andreas ; Bertheussen, Heidi ; Smolen, Josef S ; Baraliakos, Xenofon ; McGonagle, Dennis G ; Schoones, Jan W ; Aletaha, Daniel ; Winthrop, Kevin L

Objectives:

To obtain an overview of recent evidence on efficacy and safety of pharmacological treatments in psoriatic arthritis (PsA).

Methods:

This systematic literature research (SLR) investigated the efficacy and safety of conventional synthetic (cs), biological (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) in patients with PsA. A systematic database search using Medline, EMBASE, Cochrane CENTRAL was conducted to identify relevant articles published since the previous update in 2019 until 28 December 2022. Efficacy was assessed in trials while for safety observational data were also considered. Adverse events of special interest were infections (including herpes zoster, influenza and tuberculosis), malignancies, major adverse cardiovascular events, venous thromboembolisms, liver disease, laboratory changes and psychiatric adverse events. No meta-analyses were performed.

Results:

For efficacy, of 3946 articles screened, 38 articles (30 trials) were analysed. The compounds investigated included csDMARDs (leflunomide, methotrexate), bDMARDs inhibiting IL17 (bimekizumab, brodalumab, ixekizumab, izokibep, secukinumab,), IL-23 (guselkumab, risankizumab, tildrakizumab), IL-12/23 (ustekinumab) as well as TNF (adalimumab, certolizumab-pegol, etanercept, infliximab, golimumab) and Janus Kinase inhibitors (JAKi) (brepocitinib, deucravacitinib, tofacitinib, upadacitinib). The compounds investigated were efficacious in improving signs and symptoms of PsA, improving physical functioning and quality of life. For safety, 2055 abstracts were screened, and 24 articles analysed: 15 observational studies and 9 long-term follow-ups of trials, assessing glucocorticoids, TNFi, IL-17i, JAKi, IL-12/23i and PDE4i (apremilast). Safety indicators were generally coherent with the previous SLR in 2019.

Conclusion:

The results of this SLR informed the task force responsible for the 2023 update of the European Alliance of Associations for Rheumatology recommendations for pharmacological management of PsA.

31 Dec 2023·mAbs

Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis

Article

Author: Gunneriusson, Elin ; Gudmundsdotter, Lindvi ; Klint, Susanne ; Kamboj, Amol P. ; Wennborg, Anders ; Höidén Guthenberg, Ingmarie ; Frejd, Fredrik Y. ; Bejker, David ; Feldwisch, Joachim ; Nyborg, Andrew C. ; Dillner Bergstedt, Karin ; Peloso, Paul M.

Psoriasis, an immune-mediated inflammatory disease, affects nearly 125 million people globally. The interleukin (IL)-17A homodimer is a key driver of psoriasis and other autoimmune diseases, including psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, and uveitis. Treatment with monoclonal antibodies (mAbs) against IL-17A provides an improvement in the Psoriasis Area and Severity Index compared to conventional systemic agents. In this study, the Affibody^Ⓡ technology was used to identify and optimize a novel, small, biological molecule comprising three triple helical affinity domains, izokibep (previously ABY-035), for the inhibition of IL-17A signaling. Preclinical studies show that izokibep, a small 18.6 kDa IL-17 ligand trap comprising two IL-17A-specific Affibody domains and one albumin-binding domain, selectively inhibits human IL-17A in vitro and in vivo with superior potency and efficacy relative to anti-IL-17A mAbs. A Phase 1 first-in-human study was conducted to establish the safety, pharmacokinetics, and preliminary efficacy of izokibep, when administered intravenously and subcutaneously as single doses to healthy subjects, and as single intravenous and multiple subcutaneous doses to patients with psoriasis (NCT02690142; EudraCT No: 2015-004531-13). Izokibep was well tolerated with no meaningful safety concerns identified in healthy volunteers and patients with psoriasis. Rapid efficacy was seen in all psoriasis patients after one dose which further improved in patients receiving multiple doses. A therapeutic decrease in joint pain was also observed in a single patient with concurrent psoriatic arthritis. The study suggests that izokibep has the potential to safely treat IL17A-associated diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, and uveitis.

15 Sep 2023·The British journal of dermatology

Clinical trial results for treatment of psoriasis with izokibep.

Article

News (Medical) associated with Izokibep

13 Nov 2024

·www.globenewswire.com

ACELYRIN, INC. Reports Third Quarter 2024 Financial Results and Recent Highlights

Topline data from Phase 2b/3 trial of izokibep as a treatment for non-infectious non-anterior uveitis expected in December 2024 Positive lonigutamab EOP2 FDA interaction completed and initiation of subcutaneous Phase 3 development program in thyroid eye disease (TED) expected in Q1 2025 Cash, cash equivalents, and short-term marketable securities at September 30, 2024 of $562.4 million projected to provide cash runway to mid-2027 Company to hold webcast and conference call at 4:30pm ET today LOS ANGELES, Nov. 13, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today reported financial results for the third quarter ended September 30, 2024 and highlighted other corporate updates and milestones. “We are executing on our refocused pipeline strategy and are excited by the near-term catalysts ahead for ACELYRIN, particularly as we advance subcutaneous lonigutamab into Phase 3 development as the next generation IGF-1R inhibitor for thyroid eye disease. We recently concluded a positive end of phase 2 interaction with the FDA, established a world-class scientific and patient advisory board, and remain on track to initiate our Phase 3 development program in TED next quarter,” said Mina Kim, Chief Executive Officer of ACELYRIN. “We are also looking forward to announcing topline results from our Phase 2b/3 trial of izokibep in uveitis in December 2024 and hosting a lonigutamab investor event in early 2025.” Recent Pipeline Updates and Upcoming Milestones LonigutamabLonigutamab is a subcutaneously (SC) delivered humanized IgG1 monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), a validated mechanism of action (MoA) for the treatment for thyroid eye disease (TED). ACELYRIN recently completed a positive end of Phase 2 (EOP2) interaction with the U.S. Food and Drug Administration (FDA), achieving alignment on important elements of the Phase 3 registrational program design including size, primary and secondary endpoints, and proposed dose selection. The Company will host a webcast event in early 2025 to review the Phase 2 data, FDA feedback and Phase 3 program design. Earlier this year, ACELYRIN reported the first positive proof of concept data for an anti-IGF-1R in TED patients, which showed that lonigutamab was well-tolerated and demonstrated rapid improvements in proptosis and clinical activity score (CAS) – within three weeks after the first dose. Additional data from the ongoing Phase 2 trial has been recently presented by leading clinicians at international medical congresses including those of the American Society of Ophthalmic Plastic and Reconstructive Surgery, the European Society of Ophthalmic Plastic and Reconstructive Surgery, and the American Academy of Ophthalmology. These presentations can be found on the “Presentations and Publications” section of ACELYRIN’s website at www.acelyrin.com. The Phase 2 dose exploration trial is continuing with additional cohorts to establish both a minimum eﬀective and optimal dose level and dose regimen for the Phase 3 registrational program. Cohort 3 testing 50mg of lonigutamab administered every four weeks has been completed and Cohort 4 testing 70-100mg of lonigutamab administered every four weeks is ongoing. Finally, ACELYRIN established a scientific and patient advisory board convening world class clinicians and advocates to provide important strategic input, clinical expertise and patient perspectives as the Company prepares to advance lonigutamab into Phase 3 clinical development for TED. IzokibepIzokibep is a small protein therapeutic designed to inhibit IL-17A with high potency and small molecular size, approximately 1/10th the size of a monoclonal antibody. ACELYRIN previously announced that enrollment in a Phase 2b/3 trial evaluating 160mg of izokibep administered weekly as a treatment for non-infectious, non-interior uveitis had been completed in May 2024 with 96 patients. The Company expects to report topline data from the trial in December 2024. Third Quarter 2024 Financial Highlights Cash Position: Cash, cash equivalents and short-term marketable securities totaled $562.4 million at September 30, 2024. The Company expects these to fund operations to mid-2027. R&D Expenses: Research and development expenses were $31.6 million for the third quarter ended September 30, 2024, as compared to $74.6 million for the same period in 2023. The decreases were primarily a result of reduced clinical development activity as the Phase 3 trials for izokibep move toward completion. G&A Expenses: For the third quarter ended September 30, 2024, general and administrative expenses were $12.3 million, compared to $19.9 million for the same period in 2023. The decreases were primarily a result of lower stock-based compensation expenses. Net Loss: Net loss for the third quarter ended September 30, 2024 totaled $48.5 million, compared to $83.9 million for the same period in 2023. The net loss for the third quarter ended September 30, 2024 includes non-recurring restructuring expenses of $10.8 million related to the August 2024 announcement of a refocused pipeline strategy that prioritizes development of lonigutamab in thyroid eye disease. These restructuring expenses are net of a $35.7 million credit voucher that can be used to offset cash obligations for manufacturing costs including those for the lonigutamab program. Webcast and Conference Call InformationACELYRIN will host a conference call and webcast today, November 13, 2024, at 4:30pm ET to discuss these recent corporate updates. A live webcast of the conference call can be accessed in the “Events & Presentations” section of ACELYRIN’s website at www.acelyrin.com. A recording of the webcast will be available and archived on the Company’s website for approximately 30 days. Upcoming Investor PresentationACELYRIN management will attend the Jefferies London Healthcare Conference 2024 taking place from November 19-21, 2024, holding 1x1 meetings and a webcasted fireside chat on November 20, 2024. An archive of the webcast will be available in the “Events & Presentations” section of ACELYRIN’s website at www.acelyrin.com. About ACELYRINACELYRIN, INC. (Nasdaq: SLRN) is focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN’s lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease. For more information about ACELYRIN, visit us at www.acelyrin.com or follow us on LinkedIn and X. Forward Looking StatementsThis press release contains forward-looking statements including, but not limited to, statements related to ACELYRIN’s expectations regarding its cash runway and ability to fund several key milestones; the advancement of ACELYRIN’s programs and ability to accelerate the development and delivery of transformative medicines; anticipated development activities including the planned initiation of Phase 3 clinical trial of lonigutamab, establishment of proof of concept and/or the availability of clinical data; the therapeutic potential of ACELYRIN’s product candidates; the potential commercial launch of ACELYRIN’s product candidates; and other statements that are not historical fact. These forward-looking statements are based on ACELYRIN’s current plans, objectives and projections, and are inherently subject to risks and uncertainties that may cause ACELYRIN’s actual results to materially differ from those anticipated in such forward-looking statements. Such risks and uncertainties include, without limitation, those associated with the successful completion of development and regulatory activities with respect to ACELYRIN’s product candidates; maintaining and defending intellectual property protection; delays or failures to secure adequate supply of its product candidates; ACELYRIN’s failure to realize the expected benefits of its acquisition of additional programs; legal proceedings, government investigations or other actions; macroeconomic conditions; market volatility; and other risks and uncertainties affecting ACELYRIN including those described from time to time under the caption “Risk Factors” and elsewhere in ACELYRIN’s current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. Forward-looking statements contained in this press release are made as of this date, and ACELYRIN undertakes no duty to update such information except as required under applicable law. ACELYRIN, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Operating expenses: Research and development$31,612 $74,562 $166,026 $272,512 General and administrative 12,326 19,861 53,711 44,440 Restructuring 10,809 - 10,809 - Total operating expenses 54,747 94,423 230,546 316,952 Loss from operations (54,747) (94,423) (230,546) (316,952) Change in fair value of derivative tranche liability - - - 10,291 Interest income 7,535 10,502 25,132 20,486 Other income (expense), net (1,336) (19) 36,221 (254)Net loss $(48,548) $(83,940) $(169,193) $(286,429)Other comprehensive gain (loss) Unrealized gain (loss) on short-term marketable securities, net 551 (94) 222 36 Total other comprehensive gain (loss)$551 $(94) $222 $36 Net loss and other comprehensive loss$(47,997) $(84,034) $(168,971) $(286,393)Net loss per share attributable to common stockholders, basic and diluted$(0.49) $(0.87) $(1.71) $(4.68)Weighted-average common shares outstanding, basic and diluted 99,835,707 96,872,747 98,973,518 61,138,105 ACELYRIN, INC.Selected Consolidated Balance Sheet Data(unaudited)(in thousands) September 30, December 31, 2024 2023 Cash and cash equivalents$216,326 $218,097 Short-term marketable securities 346,047 503,229 Total assets 618,310 742,690 Total liabilities 90,029 86,353 Accumulated deficit (657,912) (488,719) ACELYRIN Contacts:Tyler MarciniakVice President of Investor Relations and Corporate Affairsinvestors@acelyrin.commedia@acelyrin.com

Phase 3Clinical ResultPhase 2Financial StatementPhase 1

23 Oct 2024

·www.biospace.com

Alto Depression Therapy Fails Mid-Stage Trial, 9 Months After IPO

iStock, wildpixel Alto Neuroscience’s depression treatment failed to beat placebo just nine months after the biotech went public. The stunning failure called to mind Acelyrin, which faced a similar fate last year. Alto Neuroscience’s Phase IIb therapy has failed to improve symptoms of major depressive disorder compared to placebo, sending the biotech’s shares down 60% in after-market trading Tuesday evening. The clinical failure comes nine months after Alto became one of the earliest biotechs of 2024 to IPO , raising $128.6 million in early February. The stunning failure of ALTO-100 brings back echoes of Acelyrin last year; it was one of the few biotechs to test the IPO waters in 2023, raising a massive $540 million, only to fail a clinical trial a few months later. Alto revealed the failure in an after-market release Tuesday evening. ALTO-100 did not beat placebo in the Phase IIb trial of patients with MDD, however safety and tolerability were as expected. Alto will now conduct a full analysis of the data set to determine next steps. “We are disheartened by the results from this study as the unmet need in this patient population is immense,” said Alto CEO Amit Etkin in a statement. William Blair analysts called the results “a clear miss” for Alto, pointing out that the study was well conducted and the placebo performed according to historical precedent. Stifel similarly said the drug “simply didn’t succeed.” “The press release is light on data details but quite firm in that the trial was a failure, and there (commendably) isn’t any data dredging or overreaching post-hoc analyses in an attempt to salvage the asset,” Stifel noted in a note Tuesday evening. Platform in Question The treatment was developed with Alto’s precision psychiatry platform, which has been touted as a way to develop highly personalized and effective psychiatry therapies. Analysts from Jefferies, William Blair and Stifel wondered what the read-through would be for Alto’s deeper portfolio of neuropsychiatry treatments. “The clear top-line miss of ALTO-100 in MDD undoubtedly will cast investor doubt on Alto’s Precision Neuropsychiatry approach to pair specific mechanisms of action to patient biomarkers of drug response,” William Blair’s team wrote. Alto used a memory-based biomarker to sort patients before randomizing them into treatment and placebo arms. The main endpoint was a rating on the standard Montgomery-Åsberg Depression Rating Scale (MADRS) compared to placebo at the end of the six-week treatment period. The study was conducted in the U.S. with 301 adults. Patients who were in the biomarker-defined group did not demonstrate a statistically significant improvement in depression symptoms compared to placebo. The treatment also did not spur improvement on other pre-specified key secondary endpoints. “While the results are surprising and disappointing, I am proud of our team for conducting a first-of-its-kind precision biomarker-based study in psychiatry. We will move quickly to evaluate the full data set to better understand these findings and incorporate learnings from this large data set across our platform,” Etkin said. ALTO-100 is also being studied in a Phase IIb trial of patients with bipolar disorder. While Alto was taking an innovative approach, William Blair contends the biotech took on one of the toughest challenges: depression itself. “While today’s data points draw increased scrutiny on the biomarker stratification approach, historically placebo-controlled MDD studies have been high-risk, and this one appears no different,” the firm wrote. Sage Therapeutics is one recent example. While the company achieved FDA clearance for Zurzuvae in postpartum depression, the drug was not cleared in MDD because the FDA found the company had failed to provide “substantial evidence of effectiveness” to support approval. Investors will now shift focus to Alto’s next pipeline asset, ALTO-300, which is also in development for MDD with a readout expected in the first half of 2025. The drug, also known as agomelatine, is approved in Europe and Australia for depression. Alto has already completed a Phase IIa study verifying the EEG-based biomarker to be used. William Blair analysts suggested this asset is slightly more de-risked than ALTO-100, given its existing approvals elsewhere in the world. “We still think the Alto precision psych approach has merit, and we do note that all drugs within the pipeline operate by fundamentally different mechanisms-of-action,” Stifel analysts wrote. “In our view, better patient selection, and ‘homogenizing’ trial populations, is still a winning strategy in CNS, and for this reason we do think Alto’s other shots-on-goal for fundamentally different assets should not be written off.” Alto has plenty of cash to operate on despite the failure, Etkin said in the release. The company reported $193.6 million as of June 30 , which will extend its cash runway into 2027 through multiple upcoming readouts. Besides the ALTO-300 readout next year, the company is also expecting one for ALTO-203, also in MDD. Echoes of 2023 Alto’s failure calls to mind a similar stumble last year from Acelyrin, which raised a massive $540 million in an IPO to fuel its immunology aspirations. But just months later, it reported that lead asset izokibep had failed in a Phase IIb/III trial in patients with hidradenitis suppurativa. Acelyrin’s shares tumbled by more than half and sent a chill through the markets that had already been lukewarm to biotech public debuts. Alto’s shares fell 60% to $5.70 in after-market trading Tuesday evening, compared to $14.53 at close just hours before. The company’s shares began trading on February 2 at $22 apiece. Just like Alto, Acelyrin had another arrow in its quiver with izokibep, which later met the primary endpoint of a Phase IIb/III psoriatic arthritis trial. The therapy was also retested in hidradenitis suppurativa, meeting the main goal of a Phase III trial, the company reported in August. Despite the success, Acelyrin has suspended investment in both indications for izokibep and will focus on thyroid eye disease therapy lonigutamab.

Phase 2Drug ApprovalIPOClinical Result

21 Sep 2024

·www.globenewswire.com

ACELYRIN, INC. Announces Positive Results from Global Phase 3 Clinical Trial of Izokibep in Hidradenitis Suppurativa to be Highlighted in Late-Breaking Oral Presentation at EADV 2024

Sept. 19, 2024 -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive results from the company’s global Phase 3 clinical trial of izokibep in moderate-to-severe hidradenitis suppurativa (HS) patients will be shared as a late-breaking oral presentation at the 2024 European Academy of Dermatology and Venereology taking place September 25-28, 2024 in Amsterdam, Netherlands. Presentation details are as follows: Title: Efficacy and Safety of Izokibep, a Novel IL-17A Inhibitor, in Moderate-to-Severe Hidradenitis Suppurativa: Week 12 Results from a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study Session Type: Late-breaking Oral Presentation Abstract ID: 7995 Date/Time: Wednesday, September 25, 2024; 4:00 – 4:15PM CEST Presenter: Kim Papp, M.D., Ph.D., President and Director of Research, Probity Medical Research, Inc. “The global Phase 3 clinical trial of izokibep as a treatment for HS demonstrated statistically signiﬁcant and clinically meaningful responses across multiple eﬃcacy endpoints – particularly in higher order responses such as HiSCR90 and HiSCR100 – by 12 weeks,” said Shephard (Shep) Mpofu, M.D., Chief Medical Officer of ACELYRIN. “We believe these data could support a path to regulatory approval in this indication and look forward to having the data presented in this important dermatology forum.” Izokibep is a small protein therapeutic designed to inhibit IL-17A with high potency through tight binding aﬃnity, the potential for robust tissue penetration due to its small molecular size – about one-tenth the size of a monoclonal antibody – and an albumin binding domain that extends half-life. It is currently being evaluated in multiple late-stage trials in moderate-to-severe Hidradenitis Suppurativa (HS), moderate-to-severe psoriatic arthritis (PsA), and noninfectious uveitis. Phase 3 HS and PsA data presented to date have demonstrated levels of clinical response comparable with next generation approaches to IL-17 inhibition. ACELYRIN previously announced that it would discontinue internal development of izokibep in HS and PsA. ACELYRIN, INC. (Nasdaq: SLRN) is focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN’s lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

100 Deals associated with Izokibep

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Indication	Highest Phase	Country/Location	Organization	Date
Hidradenitis Suppurativa	Phase 3	US	ACELYRIN, Inc.	22 Jun 2023
Hidradenitis Suppurativa	Phase 3	JP	ACELYRIN, Inc.	22 Jun 2023
Hidradenitis Suppurativa	Phase 3	CA	ACELYRIN, Inc.	22 Jun 2023
Hidradenitis Suppurativa	Phase 3	FR	ACELYRIN, Inc.	22 Jun 2023
Hidradenitis Suppurativa	Phase 3	DE	ACELYRIN, Inc.	22 Jun 2023
Hidradenitis Suppurativa	Phase 3	HU	ACELYRIN, Inc.	22 Jun 2023
Hidradenitis Suppurativa	Phase 3	PL	ACELYRIN, Inc.	22 Jun 2023
Hidradenitis Suppurativa	Phase 3	ES	ACELYRIN, Inc.	22 Jun 2023
Arthritis, Psoriatic	Phase 3	US	ACELYRIN, Inc.	21 Nov 2022
Arthritis, Psoriatic	Phase 3	BG	ACELYRIN, Inc.	21 Nov 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05355805 (CTgov)	Phase 2	Hidradenitis Suppurativa	205	Izokibep (Part A Izokibep 160 mg QW)	utbaxfyyak(tfqblrknod) = jigadusbal lnjlpihiwd (ieedqjbcer, cyxoobyaez - palzfczqyj) View more	-	25 Sep 2024
				Placebo (Part B Placebo QW/Q2W)	azugcolhht(ythkguiyxe) = svjfananuu hkrbxbbsua (obblpushmg, skvgtpnhao - stlclcxcgx) View more
NCT05623345 (22104, EULAR2024) Manual	Phase 2/3	Arthritis, Psoriatic	343	IZO 160 mg Q2W	nevfswuufz(kswdozylte) = oqzosjzdzm rrtoejlhse (fcpgmufpxy ) View more	Positive	12 Jun 2024
				IZO 160 mg QW	nevfswuufz(kswdozylte) = xunlyqdkaf rrtoejlhse (fcpgmufpxy ) View more
NCT05623345 (GlobeNewswire) Manual	Phase 2/3	Arthritis, Psoriatic	351	izokibep	xbqmriaivk(ehbbyykpwg) = Study met primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance enkcqyooyv (jmsviglenw ) Met View more	Positive	11 Mar 2024
				placebo
NCT05623345 (GlobeNewswire) Manual	Phase 2/3	Hidradenitis Suppurativa	175	Izokibep 160 mg QW (Part B NRI)	dqscpsooek(esgriloxob) = kimlgvjqhw cedfyotefw (umezltwodb ) View more	Negative	11 Sep 2023
				Izokibep 160 mg Q2W (Part B NRI)	dqscpsooek(esgriloxob) = vhbxwvhmmv cedfyotefw (umezltwodb ) View more
Phase 2b/3 Study (EADV2023)	Phase 2/3	Hidradenitis Suppurativa	-	Izokibep 160mg	ltjdsshfiy(acvwjxpdvi) = 3 SAEs were observed in 2 subjects: inflammatory bowel disease, an exclusionary criterion, in 1 subject with pre-existing symptoms; and peri-colonic abscess/sepsis in another subject with pre-existing symptoms and known diverticulosis srohvuneba (houighltpn ) View more	-	18 May 2023
NCT04713072 (ABY-035-202, PRNewswire) Manual	Phase 2	Arthritis, Psoriatic	-	Izokibep 80 mg Q2W	xsidyzjcbs(zfofmjbgso) = ifwbruycip mtcdkrizft (ryjzwwwmql ) View more	Positive	11 Apr 2023
				Izokibep 40 mg Q2W	xsidyzjcbs(zfofmjbgso) = sguvyoueeh mtcdkrizft (ryjzwwwmql ) View more
NCT04713072 (ACR2022) Manual	Phase 2	Arthritis, Psoriatic	135	Izokibep 40mg	sobdaztall(zhubuvfgfd) = eydogfxwir oarhjvstqi (awyqnwlnag ) View more	Positive	13 Nov 2022
				Izokibep 80mg	sobdaztall(zhubuvfgfd) = azcfuatuow oarhjvstqi (awyqnwlnag ) View more
NCT04713072 (EULAR2022)	Phase 2	Arthritis, Psoriatic IL-17	135	Izokibep 80mg	kbzfcuryrn(ykundvnets) = eixlmxzcvd iujgoxtvxq (luusdqnwps )	Positive	01 Jun 2022
				Izokibep 40mg	kbzfcuryrn(ykundvnets) = nutklczrne iujgoxtvxq (luusdqnwps )

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