CLINICAL TRIAL

Upadacitinib (ABT-494) for Eczema, Infantile

Recruiting · < 18 · All Sexes · Hershey, PA

This study is evaluating whether a drug may help treat severe atopic dermatitis in children.

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About the trial for Eczema, Infantile

Eligible Conditions
Dermatitis, Atopic · Dermatitis · Eczema · Dermatitis, Dermatitis Atopic

Treatment Groups

This trial involves 7 different treatments. Upadacitinib (ABT-494) is the primary treatment being studied. Participants will be divided into 7 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
Upadacitinib (ABT-494)
DRUG
Experimental Group 2
Upadacitinib (ABT-494)
DRUG
Experimental Group 3
Upadacitinib (ABT-494)
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
FDA approved

Side Effect Profile for Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg

Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg
Show all side effects
PYREXIA
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
ANAEMIA
6%
COLITIS ULCERATIVE
1%
DENGUE FEVER
0%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
0%
ACNE
0%
PYODERMA GANGRENOSUM
0%
ESCHERICHIA INFECTION
0%
ACUTE PSYCHOSIS
0%
ABDOMINAL PAIN LOWER
0%
COLITIS
0%
CHEST PAIN
0%
COVID-19 PNEUMONIA
0%
ABDOMINAL DISCOMFORT
0%
LARGE INTESTINE PERFORATION
0%
GASTROINTESTINAL STOMA NECROSIS
0%
PELVIC VENOUS THROMBOSIS
0%
HAND FRACTURE
0%
MALNUTRITION
0%
PULMONARY EMBOLISM
0%
HEADACHE
0%
ENTEROCOCCAL INFECTION
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03653026) in the Part 2: Upadacitinib 45 mg / Upadacitinib 45 mg ARM group. Side effects include: PYREXIA with 6%, BLOOD CREATINE PHOSPHOKINASE INCREASED with 6%, ANAEMIA with 6%, COLITIS ULCERATIVE with 1%, DENGUE FEVER with 0%.

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants with total body weight of 10 kilograms(kg) or higher at Baseline. Beginning with protocol version 6.0, only subjects 3 years of age and older will be enrolled for the remainder of this study.
Meets Hanifin and Rajka criteria for AD.
You have atopic dermatitis (AD) with onset of symptoms at least 6 months prior to baseline. show original
You have active severe AD defined by EASI, IGA and BSA. show original
You have a documented history of inadequate response or intolerance to topical corticosteroids (TCS) and topical calcineurin inhibitor (TCI) OR for whom use of TCS and TCIs is otherwise medically inadvisable. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Upadacitinib (ABT-494) will improve 5 primary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Up to 7 days.

Area under the plasma concentration-time curve within a dosing interval (AUCtau)
UP TO 7 DAYS
The area under the plasma concentration-time curve (AUCtau) is a method of measurement of the total exposure of a drug in plasma.
Maximum Plasma Concentration (Cmax)
UP TO 7 DAYS
It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Time to Maximum Observed Plasma Concentration (Tmax)
UP TO 7 DAYS
It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.
Oral Clearance
UP TO 7 DAYS
Clearance is defined the volume of plasma cleared of the drug per unit time.
Number of Participants With Treatment Emergent Adverse Events (TEAE)
UP TO 2 YEARS
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

Patient Q & A Section

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

What are common treatments for eczema, infantile?

Eczema is common, although there is no single treatment that works for all people diagnosed with eczema. Treatments include avoidance of triggers such as food, sunlight, dust, cigarette smoke, and exercise, and symptomatic medication such as topical corticosteroids. There is still the concern that some medications may have undesirable side effects such as tachycardia in young children or irritability in older children or adults. Although less common, there's the option of the surgery of epidermal photorefractive keratectomy. There's no proven treatment that allows people with eczema to go out of their home without wearing at least some form of a medical style face cover.

Anonymous Patient Answer

Can eczema, infantile be cured?

This case study highlights the importance of the early diagnosis and treatment of eczema, particularly in children with atopic or family history of eczema and atopic conditions.

Anonymous Patient Answer

What causes eczema, infantile?

The current understanding of chronic eczema was influenced by the assumption of allergic disorders as the root of the disease at early stages in the history of eczema and its treatment. Nevertheless, it is now known that non-allergic factors play a major role in the development of eczema, and eczema should be divided into non- atopic eczema and atopic eczema. The correct understanding of eczema is the foundation for a correct diagnosis and management.

Anonymous Patient Answer

What is eczema, infantile?

Eczema, infantile, is an inherited disease that often begins in early childhood. The symptoms of eczema, infantile, can be challenging to diagnose and is frequently confused with other dermatologic conditions.

Anonymous Patient Answer

What are the signs of eczema, infantile?

This paper describes the signs and symptoms of eczema in infants of different countries and compares these signs with the signs and symptoms of eczema in adults.

Anonymous Patient Answer

How many people get eczema, infantile a year in the United States?

Eczema, infantile is a leading cause of hospital utilization among American children two years of age and younger. In the USA, the incidence of eczema is more than twice the rates in Canada.

Anonymous Patient Answer

Has upadacitinib (abt-494) proven to be more effective than a placebo?

Recent findings provides compelling evidence that Upadacitinib has superiority over placebo in the maintenance of remissions in adult patients with moderate to profound, steroid-resistant atopic dermatitis in an open, parallel-group, randomized, controlled clinical study.

Anonymous Patient Answer

What are the latest developments in upadacitinib (abt-494) for therapeutic use?

Upadacitinib has shown excellent efficacy in patients with psoriasis. This is an oral, small-molecule drug that targets several of the targets involved in controlling psoriasis and other skin diseases as well. Because this drug is the first inhibitor targeting the TNF pathway with c-Jun N-terminal kinase (JNK) protein kinase as its mechanistic target, it was considered the most promising therapeutic agent for patients with psoriasis. Additional indications of interest have been found in the development of Upadacitinib. These include the treatment of arthritis and Crohn's disease.

Anonymous Patient Answer

Have there been any new discoveries for treating eczema, infantile?

Eczema is a chronic skin condition that has been affecting those who have been experiencing symptoms of eczema since they were infants. Parents may be worried that there are new medical treatments out there and may opt for a surgery for a [dermal filler or wrinkle filler, cosmetic.] Dermal filler and wrinkle filler is an cosmetic surgery that is being used with results that are long lasting.

Anonymous Patient Answer

Does upadacitinib (abt-494) improve quality of life for those with eczema, infantile?

Although safety and efficacy for ECZO were not demonstrated in this small pediatric cohort, it showed good tolerability and was well tolerated and well tolerated by patients. Therefore, patients will likely continue with abt-494 for symptom improvement through continued therapy to reach their primary endpoint(s).

Anonymous Patient Answer

Have there been other clinical trials involving upadacitinib (abt-494)?

Clinical trials have been completed and the drug was approved by the FDA for the treatment of moderate-to-severe rheumatoid arthritis. Although no clinical trials have been performed investigating the use of a single immuno-modulatory compound for the treatment of eczema and atopic dermatitis, these conditions have a high prevalence in the adult population (about 10%), and a recent Cochrane systematic review indicated that other immunomodulatory therapies in development have potential for improving quality of life in people with moderate-to-severe atopic dermatitis. The current development of abt-494 and similar drugs is warranted.

Anonymous Patient Answer

What is the primary cause of eczema, infantile?

In one in three cases in our study, eczema was primary. This is potentially unusual, because for most causes of whelping eczema, the percentage of babies who suffer from eczema drops dramatically in the first three weeks. The reasons responsible for our high rate of primary eczema are not yet determined.

Anonymous Patient Answer
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