Flex-Up

A Study to Assess Dosing Flexibility of Oral Upadacitinib Tablets in Adult Participants With Moderate to Severe Atopic Dermatitis

Brief summary

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study evaluates the dosing flexibility of upadacitinib in adult participants with moderate to severe AD. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for the treatment of moderate to severe/active immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and AD. The study is comprised of a 35-day Screening Period, a 12-week double-blind period and a 12-week single-blind period. During the double-blind period, participants are placed in 1 of 2 groups, called treatment arms and will be randomized in a 1:1 ratio to receive upadacitinib. At 12 weeks during the single blind period, participants will be blinded to the upadacitinib dose based on their EASI response and reassigned to in 1 of 6 arms. Non-responders will be placed in the Non-responder arm on or after Week 16 and will receive upadacitinib. After the last study visit, there is a 30-day follow-up visit. Approximately 600 adult participants ages 18 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 160 sites worldwide. The study is comprised of a 12-week double-blind period, followed by a 12-week single-blind period. Non-responders will be placed in the Non-responder arm on or after Week 16. Participants will receive upadacitinib oral tablets once daily for up to 36 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Interventional study

Status:
Not yet recruiting
Conditions:
Atopic Dermatitis
Enrollment:
600 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M22-000
Allocation:
Randomized
Intervention model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 18 Years to 64 Years.

Inclusion Criteria:

- Chronic AD with onset of symptoms at least 3 years prior to Baseline and participant
meets Hanifin and Rajka criteria.

- EASI score >= 16, vIGA-AD score >= 3 and >= 10% Body Surface Area (BSA) of AD
involvement at the Baseline Visit.

- Baseline weekly average of daily Worst Pruritus NRS >= 4.

- Candidate for systemic treatment defined as prior use of systemic treatment for AD, OR
previous inadequate response to TCS, TCI or PDE-4 inhibitors, OR for whom topical
treatments are otherwise medically inadvisable

Exclusion Criteria:

- Participants with current or past history of infection including:

- Two or more episodes of herpes zoster, or one or more episodes of disseminated
herpes zoster;

- One or more episodes of disseminated herpes simplex (including eczema
herpeticum);

- Human immunodeficiency virus (HIV) infection defined as confirmed positive
anti-HIV antibody (HIV Ab) test;

- Active tuberculosis (TB) or meet TB exclusionary parameters (protocol specified
requirements for TB testing);

- Active infection(s) requiring treatment with intravenous anti-infectives within
30 days, or oral/intramuscular anti-infectives within 14 days prior to the
Baseline Visit;

- Chronic recurring infection and/or active viral infection that, based on the
investigator's clinical assessment, makes the participant an unsuitable candidate
for the study;

- Confirmed COVID-19: the Baseline visit must be at least 14 days from onset of
signs/symptoms or positive SARS-CoV-2 test; symptomatic participants must have
recovered, defined as resolution of fever without use of antipyretics and
improvement in symptoms; or

- Suspected COVID-19: participants with signs/symptoms suggestive of COVID-19,
known exposure, or high-risk behavior should undergo molecular (e.g., Polymerase
chain reaction [PCR]) testing to rule out SARS-CoV-2 infection or must be
asymptomatic for 14 days from a potential exposure.

- Participants must not have evidence of Hepatitis B virus (HBV) or Hepatitis C virus
(HCV).

- Participant must not have any of the following medical diseases or disorders:

- Recent (within past 6 months) cerebrovascular accident, myocardial infarction,
coronary stenting, and aorto-coronary bypass surgery;

- History of an organ transplant which requires continued immunosuppression;

- Participant must not have a history of an allergic reaction or significant
sensitivity to constituents of the study drug (and its excipients) and/or other
products in the same class;

- History of gastrointestinal perforation (other than due to appendicitis or
mechanical injury), diverticulitis, or significantly increased risk for
gastrointestinal perforation per investigator judgment;

- Conditions that could interfere with drug absorption including but not limited to
short bowel syndrome or gastric bypass surgery; participants with a history of
gastric banding/segmentation are not excluded;

- History of malignancy except for successfully treated non-melanoma skin cancer
(NMSC) or localized carcinoma in situ of the cervix.

All the cities where the clinical studies are located

Surrey - V3R 6A7
Surrey - V3V 0C6
Markham - L3P 1X2
Waterloo - N2J 1C4

Alberta

British Columbia

More information about this study

clinicaltrials.gov