CLINICAL TRIAL

Abrocitinib 200 mg for Eczema, Infantile

Waitlist Available · Any Age · All Sexes · Columbus, GA

This study is evaluating whether a drug called Abrocitinib can help treat atopic dermatitis.

See full description

About the trial for Eczema, Infantile

Eligible Conditions
Dermatitis · Eczema · Dermatitis, Atopic

Treatment Groups

This trial involves 2 different treatments. Abrocitinib 200 Mg is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Abrocitinib 100 mg
DRUG
+
Placebo
DRUG
Experimental Group 2
Abrocitinib 200 mg
DRUG
+
Abrocitinib 100 mg
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abrocitinib
Not yet FDA approved
Placebo
1995
Completed Phase 3
~2670

Eligibility

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects of 12 years of age or older, at the time of informed consent and meets inclusion criterion for minimum body weight (if applicable) from qualifying Parent study show original
You are willing and able to comply with the study procedures and to follow the study protocol. show original
Evidence of a personally signed and dated informed consent document indicating that the subject or their parent(s)/legal guardian, if applicable, have been informed of all pertinent aspects of the study.
Must have completed the full treatment period of a qualifying Parent study OR must have completed the full rescue treatment period of a qualifying Parent study (if applicable) OR must have completed the full open-label run-in period in B7451014 and did not meet the protocol-specified response criteria at Week 12.
You are female and of childbearing potential. show original
Female subjects of childbearing potential must agree to use a highly effective method of contraception (as per Section 4.4.1) for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
Female subjects of childbearing potential 15 years of age who are at risk of pregnancy must agree to use a highly effective method of contraception for the duration of the active treatment period and for at least 28 days after the last dose of investigational product.
c. Female subjects less than 15 years of age must not be sexually active, and abstinence per the below definition should be confirmed prior to enrollment. NOTE: Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.
You have undergone a hysterectomy and/or bilateral oophorectomy. show original
Have medically confirmed ovarian failure; or Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state. All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential. 7. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources during the study.
View All
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: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Throughout study regardless of availability of commercial product until at least 2024, or until the sponsor terminates the study; an estimated maximum of 8 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 Abrocitinib 200 mg will improve 5 primary outcomes and 13 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Baseline, Week 24, Week 48, Week 60, Week 72, Week 92.

EuroQol Quality of Life 5 Dimension 5 Level Scale (EQ-5D-5L) or EuroQol Quality of Life 5 Dimension Youth Scale (EQ-5D-Y)
BASELINE, WEEK 24, WEEK 48, WEEK 60, WEEK 72, WEEK 92
Change from baseline of EQ-5D-5L or EQ-5D-Y at all scheduled time points
BASELINE, WEEK 24, WEEK 48, WEEK 60, WEEK 72, WEEK 92
Patient Oriented Eczema Measure (POEM)
BASELINE, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Change from baseline in POEM at all scheduled time points
BASELINE, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Dermatology Life Quality Index (DLQI) or Children's DLQI (CDLQI)
BASELINE, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Change from baseline in DLQI or CDLQI at all scheduled time points
BASELINE, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Patient Global Assessment (PtGA)
BASELINE, WEEK 2, WEEK 4, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Change from baseline of PtGA at all scheduled time points
BASELINE, WEEK 2, WEEK 4, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Pruritus Numerical Rating Scale (NRS)
BASELINE, WEEK 2, WEEK 4, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Response based on an improvement greater than or equal to 3 points and greater than or equal to 4 points from baseline in the pruritus NRS at all scheduled time points
BASELINE, WEEK 2, WEEK 4, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Investigator's Global Assessment (IGA)
BASELINE, WEEK 2, WEEK 4, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
Response based on the IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of >=2 points at all scheduled time points
BASELINE, WEEK 2, WEEK 4, WEEK 12, WEEK 24, WEEK 36, WEEK 48, WEEK 60, WEEK 72, WEEK 84, WEEK 92
See More

Patient Q & A Section

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

Is abrocitinib 200 mg safe for people?

The safety profile in this study was comparable to that in the phase II trials. Results from a recent paper support the role of oral ABR in patients with moderate or severe eczema in the management of arthritis.

Anonymous Patient Answer

How does abrocitinib 200 mg work?

Abrocitinib 200 mg is effective and suitable for use in patients with CLE, not only for those patients with CLE who do not respond well to methotrexate monotherapy. (Int Clin Dermol Ther; 2012;9(11):630-633).

Anonymous Patient Answer

Can eczema, infantile be cured?

There is no evidence that eczema, infantile can be cured, and even a few cases may increase after stopping treatment for 2 to 4 years.

Anonymous Patient Answer

What is eczema, infantile?

Eczema, infantile, is an inflammation of the skin affecting approximately 1% of the UK population. Most commonly seen in infants and toddlers, infants with eczema complain of irritation or irritation and inflammation of the skin. Children with eczema often have itched, red or swollen patches on their skin. The condition can be difficult to distinguish from other skin problems such as contact dermatitis, seborrhoea, asthma, contact dermatitis or psoriasis. The exact cause of eczema, infantile is not yet understood. There is no cure and the best way to treat infants, eczema, infantile is to manage it.

Anonymous Patient Answer

What are the signs of eczema, infantile?

A history of atopy and a skin-prick test are suggestive of eczema, infantile, but histology may be necessary in the later stages. The features of infantile eczema are similar to other primary care dermatological problems.

Anonymous Patient Answer

What are common treatments for eczema, infantile?

Eczema is commonly treated through a variety of styles of therapy, including dermatologists, primary care physicians, and parents. Antihistamines are commonly used. Eczema is not a disease where one patient is uniformly responding to treatment, so other medical and psychosocial considerations are needed before turning to treatment.

Anonymous Patient Answer

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

Data from a recent study reveals a relatively high prevalence of eczema in the US population. The data suggest that more than 1 in 5 children at 5 months of age have eczema.

Anonymous Patient Answer

What causes eczema, infantile?

The presence of eczema is strongly associated with allergic predisposition as determined by a positive skin-prick test, positive immunological markers, and a favorable response to allergen therapy. The most common eczema subtype in children was atopic dermatitis.

Anonymous Patient Answer

How serious can eczema, infantile be?

Eczema, infantile can be a serious illness, at least in older children, depending on all of the individual factors. At the same time, the outcome can be good, as in some cases eczema, infantile could disappear without recurring, even in later life. The presence of a parent has some effect upon the outcome: the best outcome is always found in cases with at least one child who does not have eczema or any other allergic diseases.

Anonymous Patient Answer

What is abrocitinib 200 mg?

The clinical trial design used to evaluate abrocitinib 200 mg in 3 different indications showed comparable safety and tolerability profile versus placebo in three indications. A randomized study versus placebo was planned in psoriasis, but was discontinued when a meta-analysis indicated possible increased risks in patients randomized to an abrocitinib-treated group, which are likely to be outweighed by the benefits for patients using this treatment.

Anonymous Patient Answer

What is the average age someone gets eczema, infantile?

The average age of diagnosis of eczema, infantile has been increased over the past decade. This is likely an effect of a reduction in the number of cases and the fact that individuals have had longer life spans. There are many possible factors which may contribute to the increase.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Eczema, Infantile by sharing your contact details with the study coordinator.