Josh D. Woolley, MD, PhD, professor of psychiatry and behavioral sciences, University of California, San Francisco.

 Viewpoint, Josh D. Woolley, MD, PhD, of the University of California, San Francisco, and colleagues proposed the UMBRAA blinding framework for 

, which uses a multidrug comparator to mask the placebo.¹

UMBRAA (unidentifiable multidrug blinding with reduced, authorized awareness) proposes combining agents from distinct mechanistic classes for disclosure to address unmasking rates exceeding 90% in psilocybin trials. The framework includes a consent model called authorized incomplete disclosure.

, Woolley addressed concerns the comparator resembles induced delirium rather than a controlled placebo condition.

“I would call it intoxication [with] alerted sensory processing,” Woolley said. “I think that's what psilocybin does.”

Defending Multidrug Masking in Psilocybin Trials, With Josh Woolley, MD, PhD

Why the Multidrug Comparator Isn't Delirium

Woolley noted delirium is a nonspecific syndrome often caused by infection or metabolic abnormality, conditions carrying physiological risk independent of any drug effect. He separated this risk from the intoxication and altered sensory processing the comparator itself produces.

Woolley said reproducing a similar altered state through a different pharmacology, if the approach succeeds, would force investigators to rethink assumptions about the mechanisms behind psilocybin's effects. He described the pharmacological complexity of the multidrug comparator as a requirement for effective masking rather than a design flaw.

“Yes, it's a complex pharmacology, but I see that as [a] strength or required to achieve the goal of effective masking,” he said. “If there was something simpler, I’d happily use that, but it doesn't seem like there is.”

Comparative Efficacy Trials and IRB Feasibility

Woolley says the multidrug comparator produces intoxication and altered sensory processing comparable to psilocybin, not delirium.

He argues comparative efficacy designs still tend to unmask.

He acknowledges the approach is untested and may not succeed.

Woolley defended pursuing more aggressive masking instead of a shift to comparative efficacy trial designs. He said the field has not ruled it out through trial and error.

Some investigators have already moved toward comparative efficacy designs, arguing effective masking of high-dose psychedelics is not achievable. Woolley said this alternative, which compares psilocybin directly against another active treatment such as an SSRI, carries its own blinding problem, since masking still tends to fail and participants often learn which arm they are in.

He pointed to psychotherapy research on waitlist controls, where participants assigned to wait for treatment sometimes improve less than people who never enrolled in a study at all, a finding some investigators attribute to participants knowing they are not expected to improve. Woolley said this dynamic also appears in placebo response rates: sugar pills perform better in SSRI trials than in psilocybin trials because participants assigned to SSRI placebo remain uncertain of their assignment, and psilocybin trial participants who receive placebo typically know it.

“We're not sure that our approach is going to work,” Woolley said. “It may not be possible. You may throw everything at it, and people can still tell. That is possible, but no one's tried, so I think we're all just trying to figure out how to get reliable information.”

Watch parts 1 and 2 of the interview with Woolley here: 

UMBRAA Framework Aims to Fix Blinding Failures in Psychedelic Trials

UMBRAA Framework Targets Blinding Failures in Psilocybin Trials

Editor’s note: A reported disclosure for Woolley includes Eli Lilly and Company.

Yang KH, Heifets BD, Krystal A, et al. The case for more aggressive masking in psychedelic trials. 

Matvey M, Kelley DP, Bradley ER, Chiong W, O'Donovan A, Woolley J. Modifying informed consent to help address functional unmasking in psychedelic clinical trials. 

Videos

Woolley separates intoxication from delirium and defends aggressive masking instead of a shift to comparative efficacy trial designs.

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Joseph Selvanayagam, MBBS, is a professor of cardiovascular medicine at Flinders University and the director of cardiac imaging at SA Health.

The CMR GUIDE trial failed to achieve its primary endpoint, but managed to effectively reduce sudden cardiac death among younger patients with implantable cardioverter-defibrillators (ICDs) for 

Interpreting CMR GUIDE’s Mixed Results for ICD Implantation, With Joseph Selvanayagam, MBBS

European Society of Cardiology (ESC) Congress 2026

, in Munich, Germany, by Joseph Selvanayagam, MBBS, professor of cardiovascular medicine at Flinders University and director of cardiac imaging at SA Health. In an interview with 

, Selvanayagam discussed the trial’s final results – and how they influence the question of ICDs in patients with myocardial scarring.

“In totality, I think there is enough for informed decision-making in a clinical context for your individual patient,” Selvanayagam said. “Whether this shifts the needle on guidelines in the future based on CMR-GUIDE, that’s not for me to say. That is for the field to dissect and discuss.”

The CMR GUIDE trial investigated the efficacy of ICD implantation in patients with a left ventricular ejection fraction (LVEF) between 36 and 50%, as well as myocardial scar identified by cardiovascular magnetic resonance (CMR), to reduce sudden cardiac death or hemodynamically significant ventricular 

 (HSVA). Patients were randomly assigned in a 1:1 ratio to receive either an ICD or an implantable loop recorder (ILR).

The study’s primary outcome was a composite of HSVA and sudden cardiac death. HSVA was defined as a ventricular arrhythmia that either produced syncope or was associated with hypotension. Secondary outcomes included each component independently, as well as all-cause mortality, cardiovascular mortality, quality of life, and HF-related hospitalization.

Of the 352 patients ultimately enrolled in the trial, 159 received an ICD and 163 received an ILR. An additional 25 patients were enrolled in a concurrent observational registry. By the end of the trial, 131 patients in the ICD group and 118 in the ILR arm were still alive and still had functional implants. After a median follow-up of 6.3 years, the primary composite outcome occurred in 14 of 180 patients in the ICD arm and 16 of the 173 in the ILR arm. This difference was not statistically significant.

However, sudden cardiac death did indicate a potential reduction, as 3 ICD recipients and 10 ILR recipients exhibited this secondary outcome. Additionally, of the patients enrolled in the trial, 68% were <70 years old, and Selvanayagam and colleagues concluded that these patients were less likely to experience the composite primary outcome. This highlights a potentially protective effect, which Selvanayagam suggests as a focus of future studies.

Selvanayagam also discussed his impression of how these data should be reflected in the clinic. Although the data did not display overall efficacy in this population, it did display a reduction in sudden cardiac death; however, it also reflected a worse quality of life. Patients assigned to the ICD arm during the trial reported modestly lower health-related quality of life during follow-up, which is consistent with prior trials indicating that defibrillator therapy may be associated with increased treatment burden.

“What I think is worth more of a discussion with your patient based on our data is the reduced quality of life in the ICD arm compared with the ILR arm,” Selvanayagam said. “I think that you have to discuss with your patient the potential trade-off of risk versus benefit. You have to mention that the same trial that showed this reduction of sudden death also shows that you’re likely to feel worse, have a worse quality of life.”

Editors’ Note: Selvanayagam reports disclosures with AstraZeneca, Bayer, Biotronik, Boehringer-Ingelheim, Novartis, Pfizer, and others.

Selvanayagam JB, Cleland JGF, Hillis GS, et al. Cardiovascular Magnetic Resonance to Guide Defibrillator Implantation for LVEF of 36% to 50%: The CMR GUIDE Randomized Clinical Trial. JAMA. Published online August 28, 2026. 

Flinders University. Cardiac Magnetic Resonance GUIDEd Management of Mild-moderate Left Ventricular Systolic Dysfunction (CMR_GUIDE). ClinicalTrials.gov Identifier: NCT01918215. Updated July 8, 2026. Accessed September 18, 2026. 

https://clinicaltrials.gov/study/NCT01918215?id=NCT01918215&viewType=Card&rank=1

Selvanayagam shares his thoughts on whether ICDs’ improvements in sudden cardiac death are worth the reduced quality of life.

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Iliyan D. Iliev, PhD is a professor of immunology in medicine and co-director of the microbiome core laboratory at the Jill Roberts Institute for Research in Inflammatory Bowel Disease at Weill Cornell Medicine

Fluconazole treatment was associated with improved disease activity scores in patients with 

 (IBD) and oral thrush, while a topical antifungal used to clear the same infection was not.

The finding comes from a 53-patient prospective observational study at Weill Cornell Medicine, published in Nature Medicine, that compared systemic fluconazole with a nystatin rinse in patients already being treated for mild oral thrush as part of routine IBD care.

Antifungal Therapy Eased IBD Activity, With Iliyan D. Iliev, PhD

Disease Activity Improved With Fluconazole in Both Ulcerative Colitis and Crohn's Disease

Disease activity was tracked using the partial Mayo score in patients with 

 and the Harvey-Bradshaw Index in patients with Crohn's disease. 

Iliyan D. Iliev, PhD, professor of immunology in medicine and co-director of the microbiome core laboratory at the Jill Roberts Institute for Research in Inflammatory Bowel Disease at Weill Cornell Medicine, said both groups reported improved scores with fluconazole, alongside a decreased risk of disease progression over the 8-week follow-up period.

Iliev said the team could not obtain colonoscopy or biopsy data in such a short window, so clinical indices were the best available measure. He described the 53-patient cohort as an important first step rather than a conclusive result, noting that a placebo-controlled trial would be needed to confirm any clinical benefit.

A Placebo-Controlled Trial Is Needed Before Antifungal Cotherapy Becomes Standard of Care

"If you use them very long term, some of them can lead to liver toxicity and so on. They can lead to resistance," Iliev said of antifungal drugs, explaining why his team would not recommend extended use even if the approach is validated in a larger trial.

Iliev said the next step is a placebo-controlled study with longer follow-up and colonoscopy data, to determine whether the effect is durable and clinically meaningful. He described treatment aimed at the specific windows when Candida expands, rather than continuous antifungal use, as the more realistic model, with the goal of learning whether short antifungal courses could become standard of care for the subset of patients with IBD who experience fungal overgrowth.

"There is a very fine line. People call it dysbiosis; I would call it expansion of those populations. They find an environment where they will actually grow uncontrollably, and then the immune system reacts to that," Iliev said, describing the broader balance between commensal fungi and disease. 

He added that fungal and bacterial species also play an important role in normal immune development, beyond their role in IBD.

Editor's Note: Iliev reported no relevant disclosures. 

Pan X, Conroy A, Ngima TS, et al. Antifungal therapy improves microbiome dynamics in inflammatory bowel disease. 

. Published online September 1, 2026. doi:10.1038/s41591-026-04616-y

Antifungal therapy shows potential for IBD patients with candida overgrowth. News release. Weill Cornell Medicine. EurekAlert! September 1, 2026. 

https://www.eurekalert.org/news-releases/1142314

Fluconazole was linked to improved Mayo and Harvey-Bradshaw scores; Iliev outlines the placebo-controlled trial needed next.

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, IBS and IBD, Crohn's disease, and more.

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Chovatiya said scalp, nail, and hand psoriasis can carry heavy burden even when disease extent is limited.

He said zasocitinib does not appear slow to act, with responses that may keep improving over time.

He said a once-daily pill may help patients move beyond topical therapy.

Zasocitinib, an investigational oral tyrosine kinase 2 (TYK2) inhibitor under 

US Food and Drug Administration (FDA) priority review

 for moderate to severe plaque psoriasis, produced high levels of skin clearance in hard-to-treat and high-impact regions of the body in phase 3 trials.¹˒²

Raj Chovatiya, MD, PhD, clinical associate professor of medicine at Rosalind Franklin University Chicago Medical School and founder and director of the Center for Medical Dermatology + Immunology Research in Chicago, Illinois, spoke with the 

What Zasocitinib Data Mean for Scalp, Nail, and Hand Psoriasis

Why Are Special Sites Like the Scalp, Nails, and Hands Hard to Treat in Psoriasis?

Chovatiya said special sites are challenging for two reasons. Drug penetration may be somewhat harder in these areas, raising hope the right targeted agent could deliver better efficacy. Individuals with involvement in such areas may also have limited disease extent despite feeling a burden comparable with individuals who have reported having head-to-toe plaque psoriasis.

He pointed to the scalp as part of the head and neck region patients present to others each day, and to hands used for handshakes and work. Nails and the genital region also carry undue burden, he noted. At Week 16, scalp-specific PGA scores of 0 or 1 reached 77% and 74% with zasocitinib in the two trials, and 71% and 69% of patients evaluated for palmoplantar involvement reached a hands and/or feet PGA of 0 or 1.¹

Chovatiya also highlighted an open scientific question: whether a pathogenic or target-related reason, such as the role of TYK2 in other immune signaling pathways, might help to explain differing clearance rates observed in these sites compared with biologics. The answer is not yet known, he noted.

How Quickly Could Patients See Visible Skin Changes With Zasocitinib?

About 70% of patients in the pair of phase 3 trials reached clear or almost clear skin by Week 16.¹ Chovatiya said data cuts so far suggest zasocitinib is not slow to act, and he expects patients to notice meaningful differences early. Responses also continue to improve beyond the primary period, he added, and Takeda reported clearance as early as Week 4, rising through Week 52.¹

Compared with earlier oral therapies, particularly first-generation TYK2 inhibitors, Chovatiya noted clinicians may be able to discuss a balance of speed, effectiveness, and durability.

How Could a Once-Daily Oral Option Change the Conversation About Visible Psoriasis?

For patients willing to move beyond a cream, Chovatiya said a once-daily pill resonates with how people have long thought about medications, such as antibiotics, analgesics, and cold remedies. Zasocitinib would be a chronic medication, he noted, but a daily pill remains an important part of how people view treatment.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Chovatiya previously reported serving as an advisor, consultant, speaker, and/or investigator for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Argenx, ASLAN Pharmaceuticals, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Dermavant, Eli Lilly and Company, FIDE, Formation Bio, Galderma, Genentech, GSK, Incyte, LEO Pharma, L’Oréal, Nektar Therapeutics, Novartis, Opsidio, Pfizer Inc., Regeneron, RAPT, Sanofi, Sitryx, and UCB.

Takeda. U.S. FDA accepts new drug application under priority review for Takeda's zasocitinib in moderate-to-severe plaque psoriasis. News release. September 14, 2026. Accessed September 18, 2026. 

https://www.takeda.com/newsroom/newsreleases/2026/fda-priority-review-zasocitinib-psoriasis/

Smith T. FDA priority review granted to zasocitinib for moderate to severe psoriasis. HCPLive. September 14, 2026. Accessed September 18, 2026. 

https://www.hcplive.com/view/fda-priority-review-granted-zasocitinib-moderate-severe-psoriasis

Raj Chovatiya, MD, PhD, discusses how oral TYK2 inhibitor zasocitinib may affect scalp, nail, and hand psoriasis, clearance speed, and once-daily dosing.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Although it failed to achieve its primary endpoint of reducing sudden cardiovascular death or ventricular 

, the CMR GUIDE trial did indicate a patient population that may benefit more from implantable cardioverter-defibrillators (ICDs).

CMR GUIDE Misses Primary Endpoint, Indicates Possible Cardiac Death Reduction With ICDs

 in Munich, Germany, by Joseph Selvanayagam, MBBS, professor of cardiovascular medicine at Flinders University and director of cardiac imaging at SA Health. In an interview with 

, Selvanayagam discussed the impetus for the trial and the success the investigators found despite the program’s overall failure.

“Guidelines currently do not recommend an ICD in patients with EF 36-50%, yet there is a treatment paradox there,” Selvanayagam told 

. “We treat the patients below 35%, who numerically have fewer sudden cardiac deaths, but we don’t treat the ones above 35%, where the numerical events are high. We need better risk stratifiers.”

CMR GUIDE was a multicenter randomized controlled trial investigating the efficacy of ICD implantation in patients with a left ventricular ejection fraction (LVEF) of 36-50% and cardiovascular magnetic resonance (CMR)-identified myocardial scar to reduce sudden cardiac death or hemodynamically significant ventricular arrhythmia (HSVA). Patients were eligible for inclusion if they had an LVEF within the established range attributable to 

 and evidence of ventricular scar on CMR. Patients were excluded if they had a history of cardiac arrest, cardiomyopathy related to sarcoidosis, or an established indication for an ICD, among other criteria.

Eligible patients were randomly assigned in a 1:1 ratio to either a single-chamber ICD or an implantable loop recorder (ILR). The primary outcome was a composite of sudden cardiac death or HSVA – the latter was defined as a ventricular arrhythmia that produced syncope or was associated with hypotension. Prespecified secondary outcomes included the individual components of sudden cardiac death and HSVA, all-cause mortality, cardiovascular mortality, quality of life, and HF-related hospitalization.

A total of 352 patients were enrolled and randomized; of these, 159 patients received an ICD and 163 received an ILR. The median age between groups was 65 years (interquartile range [IQR], 57-71 years), and 72% of patients had ischemic etiology. Another 25 patients without myocardial scar were also enrolled in a concurrent observational registry.

By the end of the trial, 131 patients in the ICD group and 118 in the ILR group were still alive with active implants. Median follow-up was 6.3 years (IQR, 4.8-7.6 years) – in this time, the primary composite outcome occurred in 14 of 180 patients in the ICD arm and 16 of 173 patients in the ILR arm (unadjusted HR, 0.76; 95% CI, 0.37-1.58; adjusted HR, 0.77; 95% CI, 0.37-1.59). The latter hazard ratio was adjusted for age, sex, cardiomyopathy etiology, and baseline LVEF. Neither endpoint was statistically significant.

Sudden cardiac death occurred in 3 ICD recipients and 10 ILR recipients (HR, 0.26; 95% CI, 0.07-0.95), while HSVA occurred in 12 ICD recipients and 6 ILR recipients (HR, 1.77; 95% CI, 0.65-4.81). Rates were similar for all-cause mortality, cardiovascular mortality, and HF-related hospitalization, regardless of the assigned intervention group. Among the enrolled patients, 68% were <70 years old. These patients were less likely to experience the primary outcome (HR, 0.28; 95% CI, 0.09-0.89; 

 = .01) compared to those ≥70 years (HR, 2.33; 95% CI, 0.75-7.26).

Although the primary endpoint was not achieved, Selvanayagam and colleagues noted the potential reduction in sudden cardiac death found in younger patients with low competing risk from other causes of death. Selvanayagam highlighted this in the interview, suggesting future research into this area to corroborate these findings.

“This was not an overall neutral trial,” Selvanayagam said. “The primary outcome was neutral, but there were certainly enough signals in the deep dive of the data to suggest that we need to think carefully about the design of future trials. That’s the good news – the more challenging news is that this is going to take a long time, as this is a difficult population to enroll.”

Selvanayagam JB, Cleland JGF, Hillis GS, et al. Cardiovascular Magnetic Resonance to Guide Defibrillator Implantation for LVEF of 36% to 50%: The CMR GUIDE Randomized Clinical Trial. 

Joseph Selvanayagam, MBBS, discusses the potential of implantable cardioverter-defibrillators to reduce sudden cardiac death among younger patients.

Weill Cornell investigator Iliyan D. Iliev, PhD, explains why fluconazole, not nystatin, cleared gut Candida in IBD.

How Candida Moves From Mouth to Gut in IBD, With Iliyan D. Iliev, PhD

Josh Woolley, MD, PhD, says active placebos fail to mask high-dose psilocybin and propose combining drug classes with authorized incomplete disclosure.

PTSD

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

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Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA's recent approval of Bayer's finerenone in concomitant CKD and T1D.

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The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


Type 1 Diabetes

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Diabetes Dialogue: Finerenone Approved for CKD in Type 1 Diabetes

Raj Chovatiya, MD, PhD, explains where oral TYK2 inhibitor zasocitinib may fit in psoriasis treatment after the FDA accepted its NDA under priority review.

Zasocitinib NDA Acceptance: What It Means for Psoriasis Treatment

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Articles

The FDA has granted Priority Review to dersimelagon for EPP and XLP, setting a PDUFA date for late February 2027 as LEO Pharma completes its acquisition from Tanabe Pharma.

FDA News

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Dersimelagon Gains FDA Priority Review for EPP, XLP

Atrial fibrillation (AFib) is common in patients with hypertrophic cardiomyopathy (HCM) and, once identified, raises immediate questions about how aggressively to pursue rhythm control. In this segment, Mariko Harper, MD, MS, FACC, director of the Hypertrophic Cardiomyopathy Center of Excellence at Virginia Mason Franciscan Health, and James MacNamara, MD, a non-invasive cardiologist and HCM specialist at UVA Health, compare their screening habits and management philosophies before turning to what the pivotal cardiac myosin inhibitor (CMI) trials showed about AFib risk.

Video Series

Screening and Management Approaches for AFib in HCM

Atrial fibrillation (AFib) has long shadowed hypertrophic cardiomyopathy (HCM), but the arrival of cardiac myosin inhibitor (CMI) therapy has sharpened the question of what that relationship really means. As real-world experience with mavacamten and aficamten accumulates alongside pivotal trial data and new adolescent findings from SCOUT-HCM, clinicians are working to reconcile a safety signal that looks different depending on where they look.

AFib and HCM: Setting the Stage for Safety

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

What lonvo-z is, how it works, and what a Priority Review designation means for the HAE gene-editing therapy.

Allergy

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What CRISPR Gene Therapy Means for HAE: FAQ on This 1-Time Treatment

Neal Bhatia, MD, weighs the newly approved Ameluz PDT regimen for sBCC against Mohs surgery, citing its 66% composite response rate.

Q&A: What the First FDA-Approved PDT for Skin Cancer Means for sBCC Care

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

Read 6 late-breaking updates from ERS Congress 2026 that clinicians managing respiratory disease should know.

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Latest News

Defending Multidrug Masking in Psilocybin Trials, With Josh Woolley, MD, PhD

Interpreting CMR GUIDE’s Mixed Results for ICD Implantation, With Joseph Selvanayagam, MBBS

Antifungal Therapy Eased IBD Activity, With Iliyan D. Iliev, PhD

What Zasocitinib Data Mean for Scalp, Nail, and Hand Psoriasis

CMR GUIDE Misses Primary Endpoint, Indicates Possible Cardiac Death Reduction With ICDs