A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis

Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people.
This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart.
Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.

Start Date08 Oct 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT07133633

/ RecruitingPhase 2

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)

Researchers are looking for new ways to treat radiographic axial spondyloarthritis (r-axSpA). R-axSpA is a type of arthritis that causes pain, stiffness, and inflammation (swelling) in the spine and joints in the pelvis (hip bone). Radiographic means the damage it causes can be seen on X-rays.
This study will help find out if a study medicine called tulisokibart can treat symptoms of r-axSpA. Researchers will look at different doses of tulisokibart.
Researchers want to know if at least one of the study doses of tulisokibart works better than a placebo to improve r-axSpA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.

Start Date26 Sep 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06956235

/ Active, not recruitingPhase 2

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderate to Severe Hidradenitis Suppurativa

This is a phase 2b randomized, double-blind, placebo-controlled study of the safety and efficacy of tulisokibart in participants with moderate to severe hidradenitis suppurativa. The primary hypothesis is that at least 1 dose of tulisokibart is superior to placebo with respect to the proportion of participants achieving a 50% reduction in Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 16 (ie, at end of double-blind treatment).

Start Date09 Jun 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Tulisokibart

100 Translational Medicine associated with Tulisokibart

100 Patents (Medical) associated with Tulisokibart

Literatures (Medical) associated with Tulisokibart

01 Aug 2025·Lancet Gastroenterology & Hepatology

Tulisokibart shows promise for Crohn's disease

Article

Author: Lindsay, James

01 Aug 2025·Lancet Gastroenterology & Hepatology

Safety and efficacy of the anti-TL1A monoclonal antibody tulisokibart for Crohn's disease: a phase 2a induction trial

Article

Author: Llewellyn, Heather ; Al Kharrat, Houssam ; Longman, Randy S ; Jang, InSock ; Luo, Allison ; Sands, Bruce E ; Marchelletta, Ron ; Targan, Stephan R ; DuVall, Aaron ; McGovern, Dermot P B ; Siegel, Corey A ; Yen, Mark ; Wang, Yong ; Woynarowski, Marek ; Bilsborough, Janine ; Feagan, Brian G ; Anderson, Jaclyn K ; Towfic, Fadi ; Sabino, João ; Nguyen, Deanna D ; Lu, Jiandong ; Kierkus, Jaroslaw ; Laurent, Olivier ; Muñoz-Elias, Ernesto J ; Dubinsky, Marla C

BACKGROUND:

TNF-like cytokine 1A (TL1A) is a key mediator of inflammation and fibrosis. The efficacy and safety of the anti-TL1A monoclonal antibody tulisokibart as induction treatment was assessed in adults with moderately to severely active Crohn's disease with a history of insufficient response, loss of response, or intolerance to conventional or approved biological therapies.

METHODS:

In the phase 2a, multicentre, open-label APOLLO-CD study, participants aged 18 years or older with moderately to severely active Crohn's disease, as defined by a Crohn's Disease Activity Index (CDAI) of 220-450 and a Simple Endoscopy Score for Crohn's Disease (SES-CD) of at least 6 for ileocolonic or colonic disease or at least 4 for isolated ileal disease, received intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10). This Article reports the results of the primary analysis of the induction period. The primary endpoints were safety and the proportion of participants with endoscopic response at week 12, defined as a decrease in SES-CD of at least 50% from baseline. Safety was analysed in all participants treated with tulisokibart, and endoscopic response was analysed in the per-protocol analysis set, which included all participants treated with tulisokibart with baseline CDAI and SES-CD scores, except those with prespecified important protocol deviations. This trial is registered with ClinicalTrials.gov (NCT05013905) and is closed for recruitment; an open-label extension is ongoing.

FINDINGS:

Of 101 participants screened for eligibility, 55 eligible participants were enrolled and received tulisokibart. The mean age of participants was 39·1 years (SD 15·7), 34 (62%) were male, 21 (38%) were female, and 39 (71%) had received previous biological therapy. At week 12, endoscopic response was observed in 13 (26·0% [95% CI 15·9-39·6]) of 50 participants receiving tulisokibart in the per-protocol analysis set. Adverse events occurred in 43 (78%) of 55 participants, with most adverse events being mild to moderate in severity. The most frequently occurring adverse events (≥5% of participants) were COVID-19 (six [11%] participants), urinary tract infection (five [9%]), Crohn's disease (five [9%]), anaemia (four [7%]), nasopharyngitis (three [5%]), and fatigue (three [5%]). Eight (15%) participants had serious adverse events, none of which were considered related to the study drug by the investigator. There were no deaths.

INTERPRETATION:

This proof-of-concept study showed that tulisokibart is potentially efficacious in moderately to severely active Crohn's disease and is well tolerated. Randomised controlled trials with longer duration are needed to confirm these results; a double-blind, placebo-controlled, phase 3 trial is currently underway.

FUNDING:

Prometheus Biosciences, a subsidiary of Merck & Co, Rahway, NJ, USA.

01 Jun 2025·Pharmacology Research & Perspectives

Comparative Efficacy of Different Targeted Therapies in Patients With Moderate‐to‐Severe Ulcerative Colitis: Systematic Review/Network Meta‐Analysis and Mechanistic Overview

Review

Author: Xu, Li ; Sun, Yingzhe ; Hu, Suying ; Hu, Fang ; Pan, Pingting ; Dai, Youran ; Yang, Wenhui ; Li, Qiushuang ; Liu, Shan

ABSTRACT:

Ongoing evaluations of targeted therapies for moderate‐to‐severe ulcerative colitis (UC) continue to unfold, with the emergence of novel drugs. However, head‐to‐head trials comparing these therapies are still lacking. The aim of this study is to investigate the therapeutic effects of targeted therapies in moderate‐to‐severe UC. The Cochrane Library, Web of Science, PubMed, and Embase were searched from the inception to November 12, 2024. Statistical analyses included multivariate random effects models and Bayesian modeling. Stratified and sensitivity analyses were also performed. Publication bias was assessed using funnel plots. Outcomes such as clinical response/remission, endoscopic remission, mucosal healing, quality of life, adverse events (AEs), and serious adverse events (SAEs) were used to quantify the relative therapeutic effects. Thirty‐three studies (33 reported on the induction phase; 13 reported on the maintenance phase) were identified. In the induction phase, Upadacitinib 45 mg demonstrated the highest efficacy in achieving clinical remission (OR 10.03; 95% CI, 4.83–20.80), clinical response (OR 7.96; 95% CI, 3.89–16.28), and mucosal healing rate (OR 8.91; 95% CI, 3.36–23.62). Cobitolimod 250 mg was the first‐ranked treatment (SUCRA, 92.67%) in Endoscopic remission. Vedolizumab 108 mg was the best dosage in reducing Adverse Events (AEs). The optimal dosage for reducing Serious Adverse Events (SAEs) was found to be Tulisokibart 1000/500 mg. During the maintenance phase, Etrasimod 2 mg/kg ranked first in clinical remission (OR 9.58; 95% CI, 2.82–32.59), and Upadacitinib 45 mg was superior in endoscopic remission. Additionally, the most effective medication for raising quality of life was Guselkumab 200 mg (OR 3.04; 95% CI, 1.70–5.40). Consequently, there is a need for further high‐quality research to conclusively determine the best therapeutic option.

News (Medical) associated with Tulisokibart

03 Feb 2026

·firstwordpharma.com

Merck & Co. signals confidence in defending Keytruda beyond 2028 cliff

Merck & Co. CEO Rob Davis is signalling growing confidence that Keytruda's US market protection could extend beyond the widely modeled 2028 loss-of-exclusivity (LOE) date.Speaking on Merck's fourth-quarter earnings call on Tuesday, Davis laid out the structure of Keytruda's patent estate, noting that while the core compound patent expires in December 2028, two other patents – a method-of-making patent running to May 2029 and a method-of-use patent extending to November 2029 – could delay biosimilar entry of the blockbuster cancer immunotherapy.Emerging case law"As we looked at this initially, we were conservative in our assumptions and always based off the compound patent…with the intent [though] that we would defend the entire patent estate," Davis said. "What has evolved over time is that, as case law has emerged, our confidence that we will be able to defend those additional two patents has grown, and thus there is a potential that you're going to see protection actually make it through either May or November of 2029."Still, Davis said Merck continues to model a 2028 LOE "because I think that's the conservative assumption and we'll have to see where it goes."He also reminded analysts that Keytruda faces Inflation Reduction Act (IRA) pricing pressure as of the beginning in 2029. The company previously suggested that Keytruda could find itself selected for the IRA "price setting" process as early as this year with negotiated prices taking effect in early 2028. The drug was not on the list released by the Centers for Medicare & Medicaid Services for the third round of price negotiations last week (see – Vital Signs: The bark may be gone from IRA, but can it still bite?).Shift to QlexFourth-quarter sales of the intravenous PD-1 inhibitor, along with its recently approved subcutaneous formulation, Keytruda Qlex, totalled close to $8.4 billion, up 7% year over year.Qlex alone brought in $35 million, though that's likely to climb substantially as time goes on, with nearly 40% of clinicians telling FirstWord in a recent poll that they've already started weaving it into routine practice (see – Physician Views Results: Oncologists begin integrating SC Keytruda Qlex, expect meaningful uptake within a year).Davis said Merck continues to push adoption of Keytruda Qlex, which the company expects to reach 30-40% penetration by 2028. "We have priced this to drive for the adoption from Keytruda IV to Qlex," Davis said, "and frankly, whether [the Keytruda LOE is] '28 or '29 does not change the strategy we're following."Other Q4 resultsIn other financial results, Merck said total sales during the fourth quarter of 2025 reached $16.4 billion, an increase of 5% over the same time in 2024. The company saw triple-digit growth with its pulmonary arterial hypertension treatment Winrevair ($467 million, +133%) and 21-valent pneumococcal vaccine Capvaxive ($279 million, +460%), though its Gardasil HPV vaccine continues to experience significant decline ($1 billion, -35%) as driven by lower demand in China and Japan.Enflonsia, Merck's respiratory syncytial virus (RSV) mAb to protect infants, generated $21 million in the fourth quarter, reflecting a "lower-than-expected" infant passive immunisation rate and high levels of total RSV mAb inventory on the market. Still, doctors appear to like what they've seen so far in the roughly half a year it has been on the market (see – Physician Views Results: Enflonsia picks up steam but Beyfortus boasts crown as regulators probe safety of RSV antibodies).Overall group sales in 2025 were up 1% to $65 billion. The company expects sales between $65.5 billion and $67 billion this year, though the higher end of the range falls short of the $67.6 billion analysts were expecting. Merck said it expects a $2.5-billion revenue headwind this year, including from generic competition and IRA price-setting for Januvia, as well as weaker sales of its COVID-19 therapy Lagevrio.While the fourth-quarter results "build a reasonable foundation for Merck heading into 2026," BMO Capital analyst Evan Seigerman said a lower-than-expected revenue outlook may temper expectations for the year.Meanwhile, Davis reiterated the $70-billion commercial opportunity he sees for Merck over the next decade, highlighting near-term programmes such as islatravir plus lenacapavir in HIV, long-acting antiviral candidate MK-1406 (CD388) derived from its $9.2-billion Cidara Therapeutics buyout, eye disease drug MK-3000 and TL1A mAb tulisokibart for inflammatory diseases. (see – JPM26: Merck & Co. targets $70B in revenues by mid-2030s).

VaccineAcquisitionFinancial Statement

13 Jan 2026

·firstwordpharma.com

JPM26: Merck & Co. targets $70B in revenues by mid-2030s

Merck & Co.'s impending patent 'hill' from blockbuster cancer drug Keytruda (pembrolizumab) is increasingly looking summitable. Given its efforts to offset the PD-1 inhibitor's loss of exclusivity (LOE) in 2028, the pharma now sees $70 billion in commercial opportunity by mid-2030, CEO Rob Davis said at the JP Morgan Healthcare conference on Monday (see – Vital Signs: Merck & Co.'s cliff jumping raises stakes for biotech buyers)."That will be more than double what Keytruda will be at its peak sales based on consensus estimates in 2028," he said. "Importantly, that $70 billion is $20 billion more than where we were this time last year, due to what we've added through business development and our increasing confidence in some of our internal assets."10 key assetsThe company highlighted the breadth of its pipeline, including 20 growth drivers and 80 Phase III studies under way, though the majority of its $70-billion target — about 70% — is expected to come from 10 key assets with blockbuster potential. The suite includes commercial assets Winrevair (sotatercept-csrk), Ohtuvayre (ensifentrine) — gained from its $10-billion buyout of Verona Pharma in July — and Enflonsia (clesrovimab-cfor). Other programmes are enlicitide decanoate, ifinatamab deruxtecan, sacituzumab tirumotecan (sac-TMT), tulisokibart, MK-1405, MK-3000, and a weekly HIV regimen incorporating islatravir.Nearly all of the programmes are first-in-class molecules, and enlicitide and sac-TMT have received a Commissioner's National Priority Voucher. By the end of 2026, Davis expects to have clinically de-risked $35 billion of the $70 billion goal thanks to upcoming Phase III readouts, with a "big portion" materially de-risked in the next two years. Given the updated growth outlook, Davis said he was "quite confident that we will be in a position, at a minimum, to go through a very shallow period post-LOE, returning in a few years to growth. But we aspire for more. We aspire to grow through it," though he acknowledged that Merck is "not there yet."External opportunitiesSo how can Merck achieve growth while climbing its Keytruda patent hill? M&A could certainly be a key source. Davis noted that of its $70-billion goal, half of the revenues are expected to come from external opportunities, with internal projects responsible for the other half. "We've now invested over $60 billion since 2021 in business development," he said. "But importantly, we're not done. We have more to do."Merck will continue to focus on three disease areas — oncology, cardiometabolic and cardiopulmonary — and is open to clinical assets from Phase I through Phase III. Davis noted that as the LOE approaches, the pharma has been more focused on later-stage assets. And while its takeout sweet spot is in the $15-billion range, Davis said the company "has been very clear we're willing to go larger than that" — an important disclaimer as Merck is reportedly circling a potentially $20-billion takeout of cancer drug developer Revolution Medicines, though a highly anticipated JPM deal has not yet come to fruition (see – Vital Signs: The biggest buyers ahead of JPM)."If we see an opportunity that brings the science, where we see value will move, we have the capacity, I think, to do pretty much anything we would want to do," Davis concluded.

AcquisitionPhase 3Phase 1Phase 2

04 Nov 2025

·www.fiercepharma.com

Merck writes tale of 2 checks, bagging $700M from Blackstone and spending $150M to regain asset

A deal with Blackstone Life Sciences gives some idea of how big a bet Merck is making on sac-TMT. Merck & Co. began Tuesday with back-to-back deals, revealing separate agreements to pay $150 million upfront for full control of an early-phase asset and pocket $700 million to support an expansive pivotal oncology push.The influx of cash comes from Blackstone Life Sciences, which has agreed to fund a portion of the cost of developing sacituzumab tirumotecan (sac-TMT) throughout 2026. Merck recently started its 15th global phase 3 trial of the antibody-drug conjugate (ADC). That broad bet reflects a belief that the TROP2-directed ADC can become a “workhorse” for Merck as it prepares for the arrival of biosimilar Keytruda copies, Marjorie Green, M.D., Merck’s senior vice president and head of oncology global clinical development, recently told Fierce Pharma.Teaming up with Blackstone allows Merck to share the burden of validating sac-TMT in a wide range of settings. In exchange, the drugmaker has agreed to pay Blackstone low- to mid-single-digit royalties on net sales of sac-TMT across all approved indications in its marketing territories, provided the ADC wins FDA approval in first-line triple-negative-breast cancer (TNBC) based on findings of the TroFuse-011 trial.Merck secured ex-China rights to sac-TMT from Kelun-Biotech for $47 million upfront and up to $1.4 billion in milestones in 2022. The agreement gave Merck a rival to Gilead Sciences' Trodelvy and AstraZeneca and Daiichi Sankyo’s Datroway, TROP2-directed ADCs that are approved in the U.S. The rivalry between Trodelvy and Datroway is set to expand to the first-line TNBC market referenced in Merck’s deal with Blackstone. The Blackstone deal gives some idea of how big a bet Merck is making on sac-TMT—and the opportunity that awaits the ADC if it lives up to the company’s expectations. Merck said the $700 million will only fund a portion of its sac-TMT development costs. At a 4% royalty rate, total sac-TMT sales would need to reach $17.5 billion before Blackstone’s returns exceeded its $700 million upfront outlay. Another deal unveiled Tuesday showed one way Blackstone could accelerate the timeline for making a return on its investment. Royalty Pharma has paid funds managed by Blackstone $310 million for royalty interest in Alnylam’s Amvuttra. Blackstone secured the interest in 2020 by committing up to $150 million to support a phase 3 trial of Amvuttra, much like it is now doing for Merck’s sac-TMT. Five minutes before disclosing the Blackstone agreement, Merck revealed that it has struck a deal with Dr. Falk Pharma for MK-8690. Merck acquired the anti-CD30 antibody in 2023 in its $10.8 billion takeover of Prometheus Biosciences, a deal that primarily focused on the anti-TL1A candidate PRA023. In 2020, Prometheus accepted a “low seven figures” upfront payment from Falk to form a co-development pact.The outlay, plus R&D funding and other commitments, secured Falk rights to the candidate in Europe, Australia and New Zealand. Merck has retaken control by offering Falk $150 million upfront to end the collaboration. Falk is eligible to receive a payment associated with a development milestone and royalties on sales in certain territories. Merck’s outlay represents a show of confidence in a candidate that has largely flown under the radar to date. Dean Li, M.D., Ph.D., president of Merck Research Laboratories, commented on the CD30 program at a Goldman Sachs event in June 2024, telling attendees to expect more details “in the next year or so.” The forecast was tied to a phase 2 program that, based on information on ClinicalTrials.gov, is yet to get underway.

License out/inPhase 3AcquisitionADC

100 Deals associated with Tulisokibart

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	Phase 3	United States	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	China	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Japan	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Australia	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Austria	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Belgium	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Brazil	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Canada	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Chile	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Colombia	Merck Sharp & Dohme LLC	05 Jun 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	Colitis, Ulcerative	-	Tulisokibart 100 mg	ojhhfzrjjm(vgylfagwgw) = Through week 50, AEs occurred in 63% and 77% of patients receiving tulisokibart 250 mg and 100 mg, respectively; most were mild to moderate in severity. Serious AEs occurred in 1 patient (3%) and two patients (7%) in the tulisokibart 250 mg and 100 mg groups, respectively. weaitpxwga (buekjwnldr )	-	13 Oct 2024
				Tulisokibart 250 mg
NCT04996797 (ARTEMIS-UC, Pubmed \| N Engl J Med) Manual	Phase 2	Colitis, Ulcerative	135	Tulisokibart	llzokmavlg(ighlsxctjl) = preqhdwzko kstdfxwrjt (jsxbptsqxn )	Positive	26 Sep 2024
				Placebo	llzokmavlg(ighlsxctjl) = ikyjtvcfyr kstdfxwrjt (jsxbptsqxn )
NCT04996797 (ARTEMIS-UC, CTgov)	Phase 2	Colitis, Ulcerative	178	Tulisokibart (Cohort 1 Tulisokibart)	cijgvyyeoa = iuvnqbczzq dljjfcsrey (qzfwtbtqoa, qtcvzcjvpv - udpizbniuk) View more	-	27 Jun 2024
				Placebo (Cohort 1 Placebo)	cijgvyyeoa = jewwrszuhe dljjfcsrey (qzfwtbtqoa, wapnluptkz - beqkvzdtdo) View more
NCT05013905 (APOLLO-CD, CTgov)	Phase 2	Crohn Disease	55	Companion diagnostic (CDx)+PRA023 IV	xutcgcwrim = bkofilibqc ittjyrmfju (renxfyoept, kkoiyiwqcr - ewuqxqxikh) View more	-	01 Nov 2023
NCT04996797 (ARTEMIS-UC, UEGW2023)	Phase 2	Ulcerative colitis, active moderate eosinophils \| neutrophils	135	PRA023	qluszbstko(nrkofzejgk) = wpburetfhm oqvmrmqxpt (ujqlqqmkfm ) View more	Positive	15 Oct 2023
				Placebo	qluszbstko(nrkofzejgk) = suekxmvyin oqvmrmqxpt (ujqlqqmkfm ) View more
UEGW2023	Not Applicable	Ulcerative colitis, active moderate	-	PRA023	arvrnfvkcq(fkxkqjyidr) = gmfccnjrxs wdkwtklshb (zqouglgiml, 34.85) View more	-	15 Oct 2023
				Placebo	arvrnfvkcq(fkxkqjyidr) = qlmfumtafs wdkwtklshb (zqouglgiml, 37.59) View more
ARTEMIS-UC \| COHORT 1 (UEGW2023)	Phase 2	Ulcerative colitis, active moderate TL1A	135	PRA023	xnnwyiytej(oqcvbytotf) = ggpcivwviw litbtixqmz (wnafonzfve ) View more	Positive	15 Oct 2023
				Placebo	xnnwyiytej(oqcvbytotf) = bjziafwror litbtixqmz (wnafonzfve ) View more

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