Guselkumab for Psoriasis

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Brigham and Women's Hospital, Boston, MA
Psoriasis
Guselkumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug that targets a molecule called IL-23 can prevent the development of psoriatic arthritis.

See full description

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Psoriasis

Study Objectives

This trial is evaluating whether Guselkumab will improve 2 primary outcomes and 8 secondary outcomes in patients with Psoriasis. Measurement will happen over the course of Baseline, week 24.

Baseline, Week 24
Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score
Baseline, Year 2
Change in EuroQol-5D (EQ-5D) Score
Baseline, week 24
Change in Madrid Sonographic Enthesis Index (MASEI) Score
Change in the ultrasound composite score of synovitis
Week 24
Achieved IGA mod 2011 Score
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale
Psoriasis Body Surface Area (BSA)
Year 1
Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1
Year 2
Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2
Severity of PsA at the time of synovio-entheseal development

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Psoriasis

Side Effects for

Ixekizumab
Injection site reaction
9%
Upper respiratory tract infection
8%
Nasopharyngitis
7%
Myxoedema coma
0%
Endometrial cancer stage iv
0%
Acute myocardial infarction
0%
Crohn's disease
0%
Pancreatitis acute
0%
Colitis ulcerative
0%
Sepsis
0%
Gastritis
0%
Salivary gland calculus
0%
Pemphigoid
0%
Infection
0%
Rhabdomyosarcoma
0%
Angioedema
0%
Ventricular tachycardia
0%
Coronary artery disease
0%
Hypertensive urgency
0%
Cellulitis
0%
Fall
0%
Pyelonephritis
0%
Oesophageal adenocarcinoma
0%
Cardiac failure congestive
0%
Ascites
0%
Syncope
0%
Complicated appendicitis
0%
Angina unstable
0%
Myocardial infarction
0%
Cholecystitis
0%
Diabetic ketoacidosis
0%
Major depression
0%
Concussion
0%
Pneumonia
0%
Transient ischaemic attack
0%
Psoriasis
0%
Ulna fracture
0%
Cholelithiasis
0%
Suicidal ideation
0%
Benign prostatic hyperplasia
0%
Anaphylactic reaction
0%
Upper limb fracture
0%
Ischaemic stroke
0%
Deep vein thrombosis
0%
Ureterolithiasis
0%
Joint dislocation
0%
Asthma
0%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03573323) in the Ixekizumab ARM group. Side effects include: Injection site reaction with 9%, Upper respiratory tract infection with 8%, Nasopharyngitis with 7%, Myxoedema coma with 0%, Endometrial cancer stage iv with 0%.

Trial Design

3 Treatment Groups

Standard-of-Care Therapy (SOC)
1 of 3
Guselkumab + Topicals (GUS)
1 of 3
Placebo + Topicals (PBO)
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

This trial requires 350 total participants across 3 different treatment groups

This trial involves 3 different treatments. Guselkumab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Guselkumab + Topicals (GUS)
Drug
Standard-of-Care Therapy (SOC)In this third, non-randomized arm, patients would continue treatment with topical therapy or UVB, as part of our ongoing natural history of disease registries. This arm will include participants fulfilling RM-PsASon criteria but also those that do not (to serve as "negative" controls).
Placebo + Topicals (PBO)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: year 2
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly year 2 for reporting.

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
18 years old or older;
Both male & female;
Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
Willing and able to provide informed consent;
Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration >2 years and Psoriasis Body Surface Area (BSA) >3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of >3.36

Patient Q&A Section

What causes psoriasis?

"The risk of developing psoriasis seems to increase with age. However, there is some evidence that it may be related to the development of certain types of bacterial infection in early childhood. Genetic factors are also thought to play a role. There is no conclusive evidence of a link between psoriasis and HIV Infection. Psoriasis seems to have no cause or a multiple cause with many causes.\n" - Anonymous Online Contributor

Unverified Answer

Can psoriasis be cured?

"The only way psoriasis can be cured is if all the immune cells are removed as part of the inflammatory process of psoriasis. This is similar to what happens in a good course of immunosuppressive therapy, and may be the only way to remove the root cause of psoriasis. Patients are more likely to get a successful result if their course includes a tight regime of topical therapy." - Anonymous Online Contributor

Unverified Answer

What is psoriasis?

"Symptoms and signs may appear similar to other skin disorders. When psoriasis affects a joint, symptoms include redness, warmth that is worse around the eyes or in the wrists and hands. A biopsy of the redness will help distinguish it from another condition. When skin lesions show signs of a life threatening infection, a biopsy sample is taken and tested for bacteria and fungi. The diagnosis can be made without a biopsy by using a dermatology and rheumatology consultation. Psoriasis has many causes and can be long-term in some cases, often leading to serious joint problems." - Anonymous Online Contributor

Unverified Answer

How many people get psoriasis a year in the United States?

"Only 17.5 million adults in the US are affected by psoriasis a year, or 5% of individuals with skin disease. This accounts for 4.2 million clinic visits annually, and the total annual indirect costs of psoriasis are nearly $3 billion." - Anonymous Online Contributor

Unverified Answer

What are the signs of psoriasis?

"There are many signs of psoriasis, all of them non-specific to the disease. Symptoms usually manifest as itching, swollen joints, skin lesions and nails, red skin, and nail psoriasis in the toes. The red, scaly patches are also a sign of psoriasis. The characteristic 'corky' (sometimes 'plaque-like') bumps can also occur. It also can affect the eyes and skin folds around the mouth, lips, and armpits. Other symptoms may include headaches, muscle aches and pains (non-specific), fatigue (common in younger patients), and weight gain (in children)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for psoriasis?

"Dapsone is typically given for the treatment of moderate to severe cases of psoriasis.\n- Phototherapy with long-wavelength (>600 nm) UV-A or UV-B is a very effective treatment for psoriasis." - Anonymous Online Contributor

Unverified Answer

Is guselkumab safe for people?

"Guselkumab is well tolerated with low rates of serious adverse events across indications. In addition, safety data suggests that guselkumab is an intriguing, powerful treatment option, and clinical development should continue." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets psoriasis?

"Women are less likely to get psoriasis than men. A larger portion of psoriasis patients develop the disease at younger ages. More than 50% of psoriasis patients develop the condition before age 20. The average ages for a 50% of psoriasis patients with disease onset in the ages of 9‐19 are as follows: 17.0 in females, 15.5 in males. The average age of 50% with disease onset before age 20 is as follows: 20.5 in females, 20.3 in males." - Anonymous Online Contributor

Unverified Answer

Does psoriasis run in families?

"Data from a recent study are consistent with a recessive gene locus affecting all forms of psoriasis, with major contribution from the HLA-Cw6 allele. This finding implicates new targets for the development of treatments for psoriasis." - Anonymous Online Contributor

Unverified Answer

What is guselkumab?

"It's been just 3 months since guselkumab became commercially available. The patient group included in this open-label trial were largely young, well-to-do with a median duration of psoriasis (12.8 years) and moderate body mass index (BMI) (27.7 kg/m). In comparison with placebo (N=61), psoriatic arthritis (N=35) was significantly greater relative to placebo and all other treatment groups (relative to placebo, p<0.05; relative to adalimumab and ustekinumab, p<0.05; relative to ustekinumab, p<0.05)." - Anonymous Online Contributor

Unverified Answer

How serious can psoriasis be?

"Even moderate quantities of psoriasis are a severe disease and hence a potential cause of premature death, especially in men. The main causes of this remain unclear, but the disease is strongly associated with immunosuppression due to illness and/or medication." - Anonymous Online Contributor

Unverified Answer

Has guselkumab proven to be more effective than a placebo?

"Adalimumab was not more effective in terms of safety, duration, or time to response compared with placebo. Overall, guselkumab has modest efficacy in psoriasis patients, with no obvious advantage compared with the best treatment of conventional therapeutic agents." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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