A 24 week multinational multi-center study consisting of a 12-week single blind study to evaluate the efficacy and safety of methotrexate versus azathioprine treatment in adult patients with chronic severe atopic dermatitis and a 12-week follow up period.

Phase 3

Completed

• Conditions: allergic eczema; Atopic eczema; 10001708; 10014982

• Registration Number: NL-OMON33396
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

1. Subject is 18 years of age or older at inclusion (Day 0); both genders.
2. Subject has a diagnosis of AD based on millennium criteria (with or without IgE)
and UK-criteria.
3. Subject has a score of 8-9 on the Rajka and Langeland Criteria which corresponds with a severity of *severe*.
4. Subject is unresponsive, contra-indicated or intolerant to CsA treatment.
5. Female subject is either not of childbearing potential, defined as postmenopausal or surgically sterile or is of childbearing potential and practicing one of the following methods of birth control throughout the study until 3 months after receiving the last study agent:
- Intrauterine device (IUD)
- Contraceptives (oral, parenteral, patch) for three months prior to study drug administration.
- A vasectomized partner
6. Female subjects of childbearing potential must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at Baseline.
7. Sexually active male subjects are able to participate in the study if they use effective contraception during the study and 3 months after discontinuation of the study drug.
8. Have screening laboratory test results within reference values or results without clinical relevance as assessed by the local investigator.
9. Subjects has voluntarily signed and dated an informed consent prior to any study related procedure and is willing to comply with the requirements of this study protocol which has been approved by an Institutional Review Board (IRB/Independent Ethics Committee (IEC)).

Exclusion Criteria

1. Subjects is pregnant, nursing, or planning pregnancy (men and women) while enrolled in the study.
2. Subjects has used any investigational drug within the previous 4 weeks or 5 times the half-life of the investigational agent prior to the first administration of study agent, whichever is longer.
3. Subject has ever used azathioprin or methotrexate before
4. Subject has received phototherapy or any systemic medications/treatments that could affect AD evaluation (including, but not limited to, oral or injectable corticosteroids) within the last 4 weeks of the first administration of study agent.
5. Subject has used very potent topical medications/treatments that could affect AD evaluation within 2 weeks of the first administration of study agent.
6. A history of chronic or recurrent infectious diseases, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), or open, draining, or infected skin wounds or ulcers.
7. A history of alcohol abuse
8. A history of latent or active granulomatous infection, including TB, histoplasmosis, or coccodioidomycosis, prior to screening.
9. Subject has or had had herpes zoster infection within 2 months of study day 0.
10. Subject is known to be infected with HIV, hepatitis B, or hepatitis C.
11. A history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
12. Subject has a transplanted organ (with exception of a corneal transplant > 3 months prior to the first administration of study agent).
13. Subject has any known malignancy or had a history of malignancy
14. Subject is dependant of a concomitant medication that has interaction with the study medication and thereby should be avoided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy variables are difference in mean change of the SCORAD and<br /><br>IGA between groups at week 12.<br /><br><br /><br>Also the comparison in the proportion of subjects with a SCORAD reduction of<br /><br>50% or more and the proportion of subjects with a IGA score of < 3 (clear /<br /><br>almost clear / mild) at week 12 between methotrexaate an azathioprine (Arm 1<br /><br>and Arm 2).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy parameters assessed at different time points during the<br /><br>study are:<br /><br><br /><br>• Frequency and severity of Adverse Events<br /><br>• Frequency of relapses (>SCORAD75 after response (SCORAD50) was met before)<br /><br>• Absolute and relative change from Baseline up to weeks 12 on the Eczema area<br /><br>and severity index (EASI), Investigator*s global assessment (IGA), Patient*s<br /><br>global assessment (PGA), Skindex-17, Patient oriented eczema measurement<br /><br>(POEM), Pruritus visual analogue scale (VAS), Sleeplessness visual analogue<br /><br>scale (VAS).</p><br>