A Phase 2b, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of ATI-1777 in Patients 12 to 65 Years Old with Moderate or Severe Atopic Dermatitis (AD)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
Updated on 29 September 2022
progestogen
topical agents

Summary

This is a Phase 2b, randomized, double-blind, vehicle-controlled, parallel-group study to determine the efficacy, safety, tolerability, and PK of ATI-1777 Topical Solution applied QD or BID to target areas of patients with moderate to severe AD. The study will consist of an up to 30-day Screening Period, a 4-week Treatment Period, and a 2-week Follow-Up Period. The total duration of the study for patients remaining until their final follow-up assessment will be up to 42 days.

Description

Sample size: Approximately 240 subjects are planned to be enrolled. Subjects will be randomized (2:2:2:1:2:1) to ATI-1777 Topical Solution, 0.5% w/w BID, 1% w/w BID, 2% w/w BID, or Vehicle BID or ATI-1777 Topical Solution, 2% w/w QD or Vehicle QD.
 
Study design:
 
1.     Screening: up to 30 days.
2.     Randomization: 4 weeks of treatment
3.     BID: ATI-1777 Topical Solution 0.5% w/w, 1% w/w, 2% w/w (each concentration) 4 weeks or Vehicle 4 weeks. Or
4.     QD:ATI-1777 Topical Solution 2% w/w 4 weeks or Vehicle 4 weeks
5.     PTFU: 2 weeks after last dose of study drug.
 
The total duration of the study for patients remaining until their final F/U assessment will be up to 42 days.
 
Primary Objective: To assess the efficacy of ATI-1777 topical solution in patients with moderate or severe AD.

Details
Condition Eczema (Atopic Dermatitis), Eczema (Atopic Dermatitis - Pediatric), Dermatitis, Atopic, Atopic Dermatitis
Clinical Study IdentifierTX307743
Last Modified on29 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related
procedures
Male patients or non-pregnant, non-nursing female patients 12 to 65 years old, inclusive, at the time of informed consent/assent
Pregnancy and Contraception
Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit, a negative urine pregnancy test immediately prior to the first application of study drug on Day 1, and a negative urine pregnancy test at each study visits thereafter
Women of childbearing potential must agree to use one highly effective contraceptive method throughout the Screening Period, during the active treatment portion of the study, and 30 days following last study drug application, as described below
Acceptable as highly effective methods of contraception are the following
ombined (estrogen and progestogen) hormonal contraception associated with inhibition of ovulation (oral,intravaginal or transdermal) progestogen-only hormonal contraception associated with inhibition of ovulation
(Oral, injectable, implantable)
intrauterine device (IUD)
intrauterine hormone-releasing system (IUS)
bilateral tubal occlusion o vasectomized partner (see Note 1)
sexual abstinence – (see Note 2)
Note 1: Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success
Note 2: In accordance with CTFG guidance, (Recommendations related to contraception and pregnancy testing in clinical trials. Clinical Trials Facilitation and Coordination Group (CTFG) 2020): sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject
Male study candidates with partners of childbearing potential can qualify for participation if they
Are documented to be surgically sterile (had a successful vasectomy)
Remain sexually abstinent (see Note 2) for the entire study duration, and 90 days after last application of study drug, or
Agree to use a physical barrier method (such as a condom), for the entire study duration and 90 days after the last application of study drug
Have a diagnosis of AD fulfilling the specified diagnostic criteria of Hanifin and Rajka (Hanifin and Rajka 1980)
Have at least a 6-month history of AD prior to the Screening Visit, and no significant AD flares for the 4 weeks prior to the Screening Visit
Have a diagnosis of moderate or severe (vIGA score 3 or 4) AD at the Screening and Baseline Visits
Have a diagnosis of moderate or severe (EASI ≥ 7.1) AD at the Screening and Baseline Visits
Have AD affecting ≥ 5% BSA at the Screening and Baseline Visits
Willing to refrain from washing area of treatment or swimming for 4 hours after each study drug application
Willing to refrain from excessive sun exposure (eg, sunbathing and/or tanning salon visits) and to minimize sun exposure (eg, wear sun protection clothing, hat) as much as possible
Willing to refrain from use of moisturizers and emollients on AD study treatment areas for duration of protocol therapy
Willing to refrain from participating in strenuous exercise that would cause profuse sweating for a period of 4 hours after each study drug application
Willing to return to the clinic, follow all study instructions, attend all study visits, and complete study procedures
In good general health and free of any known disease state or physical condition that, in the investigator’s opinion, might impair evaluation of the patient or that might expose the patient to an unacceptable risk by study participation
Willing and capable of taking appropriate coronavirus disease 2019 (COVID19) risk mitigation precautions as required by local, state, or federal guidelines during participation in the study

Exclusion Criteria

Unstable course of AD (spontaneously improving or rapidly deteriorating) based on the patient history or as determined by the investigator during the Screening Period
Concomitant skin disease or clinically infected AD or presence of other skin disease in the area to be dosed that may interfere with study assessments
Refractory AD (ie, AD that required frequent hospitalizations and/or frequent intravenous treatment for skin infections within the year before the Screening Visit)
Use of any of the following treatments within the indicated washout period prior to Day 1
Any signs or symptoms associated with AD therapy (eg, history of anaphylaxis, hypersensitivity reactions, skin atrophy, striae, pigmentary changes) that, in the investigator’s opinion, might impair the evaluation of the AD or which exposes the patient to unacceptable risk by study participation
Phototherapy (ultraviolet A, ultraviolet B, or psoralen and ultraviolet A therapy, PUVA) within 4 weeks prior to randomization
Systemic biologic immunosuppressant or immunomodulatory therapy (eg, etanercept, alefacept, infliximab, dupilumab) within 12 weeks (or 5 half-lives of the IP, whichever is longer) prior to randomization
Non-biologic immunosuppressants (eg, methotrexate, retinoids, calcineurin inhibitors, cyclosporine, hydroxycarbamide [hydroxyurea], azathioprine) within 4 weeks prior to randomization
JAK inhibitors (systemic and topical) within 4 weeks prior to randomization
Systemic corticosteroids within 2 weeks prior to randomization (intranasal, inhaled, and topical ocular corticosteroids are allowed)
Cytostatic agents within 4 weeks prior to randomization
Crisaborole within 4 weeks prior to randomization
Systemic antibiotics within 30 days prior to randomization
Topical treatments for AD (corticosteroids, calcineurin inhibitors, topical antihistamines, topical antimicrobials, and other medicated topical agents) within 2 weeks prior to randomization
Other IP within 30 days or 5 half-lives (whichever is longer) prior to randomization
Previous failure to respond to prior therapy with JAK inhibitors (systemic or topical), as determined by the investigator
Current use of an oral H1 antihistamine (eg, diphenhydramine, terfenadine) unless the patient is on a stable dose for at least 14 days prior to the Screening Visit
Recreational marijuana is excluded. Medical marijuana is also excluded unless the patient is on a stable dose for at least 14 days prior to the Screening Visit
Clinically significant laboratory abnormalities at the Screening Visit that, in the opinion of the investigator, could affect interpretation of study data or the safety of the patient’s participation in the study
Clinical laboratory values
WBC count <3x10³/uL
ANC <1.5x10³/uL
Platelet count <130x10³/uL
Lymphocyte <1 × 10³/µL
Hemoglobin <10 g/dL
AST or ALT >2 × ULN
Investigator assessed history of or current physical findings of progressive or uncontrolled immunologic, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (renal), hematological, neurologic or cerebral disorders, infectious disease or coagulation disorders that, as determined by the investigator, could affect the safety of the patient’s participation in the study or would preclude participation in and completion of study assessments
History of venous thromboembolism
History of current or suspected systemic or cutaneous malignancy and/or lymphoproliferative disease within the last 5 years, other than patients with a history of adequately treated and well healed and completely cleared nonmelanoma skin cancers (ie, basal or squamous cell carcinoma) or cervical carcinoma in situ treated successfully at least 1 year prior to the Screening Visit 1, with no evidence of disease
Evidence of active, chronic, or latent infections at the time of enrollment or a systemic infection including but not limited to a history of treated infection (eg, pneumonia, septicemia) within 3 months prior to Day 1
Study candidate has active tuberculosis, or history of incompletely treated or untreated active tuberculosis. Potential participants with a history of active tuberculosis must have documented adequate treatment verified by the investigator. Potential participants with a positive QuantiFERON® Tuberculosis Gold Test will be allowed to participate in the study if there is documented evidence of a completed treatment course for latent tuberculosis and if active tuberculosis is excluded per the investigator’s judgment
History of a serious local skin infection (eg, cellulitis, abscess) within 5 years of the Screening Visit
Positive test results for HIV (antibody); hepatitis C virus (antibody); hepatitis B serology results (e.g., positive hepatitis B surface antigen, positive hepatitis B core antibody etc.) consistent with active or chronic infection; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Screening Visit
Herpes zoster or cytomegalovirus infection that resolved less than 2 months prior to the Screening Visit. Patients with a history of frequent outbreaks of herpes simplex virus (defined as 4 or more outbreaks a year)
Clinically significant ECG findings such as, but not limited to, baseline mean QT interval corrected using Fridericia’s formula (QTcF) >450 msec (use of the ECG algorithm is acceptable for this purpose)
Known allergy to any of the inactive ingredients in the study drug
Female patients who are pregnant, nursing, or planning to become pregnant during the study
Legal incapacity or limited legal capacity
Major surgery within 3 months of the Screening Visit
Any other condition that precludes adequate understanding, cooperation, and compliance with study procedures or any condition that could pose a risk to the patient’s safety, according to the investigator’s judgment
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note