Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
15
Countries
1
Sites
1
Mycosis Fungoides
Does treatment with Xeljanz decrease disease activity?
Key facts
- Sponsor
- Aarhus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 10 Jan 2023 → 6 Aug 2025
- Decision date (initial)
- 2022-07-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
Does treatment with Xeljanz decrease disease activity?
Conditions and MedDRA coding
Mycosis Fungoides
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- Men or women aged 18 or older at the time of consent
- Histologically confirmed diagnosis of Mycosis Fungoides (stage IA, IIA and IIB)
- Stable disease
- No change in medication for 2 months or 5 half-lives prior to study entry
- Must have received the yearly flu vaccine and covid-19 recommended vaccines
- Absolute neutrophil count ≥ 1 x 10^3/µL
- Platelets ≥ 100 x 10^3/µL
- Hemoglobin level ≥ 5.5 mmol/L
- Bilirubin level ≤ 1.5 times the specific institutional upper limit of normal (ULN)
- Alanine transaminase (ALT) level ≤ 2.5 times the specific institutional ULN
- Serum-creatinine ≤ 1.5 x ULN
- Negative test for tuberculosis, HIV, hepatitis B and C
- Women of childbearing potential and men must agree to use safe contraception methods during the study and minimum 4 weeks after termination of treatment
- Must be willing to participate and must be capable of giving informed consent, and the consent must be obtained prior to any study-related procedures
Exclusion criteria 14
- Sézary syndrome (cancerous T-cells are found in the blood)
- Concomitant treatment with UVB, acitretin, interferon or bexarotene
- Psychiatric illness, disability or social situation that would compromise the safety of the subject or ability to provide consent
- Increased thromoboembolic risks (earlier thromoboembolic events)
- Ongoing infections requiring antibiotics
- Clinically significant cardiac disease (NYHA class III or IV)
- Unstable angina pectoris
- Uncontrolled hypertension (systolic blood pressure (BP) > 160 mm Hg or diastolic BP > 100 mm Hg, found on two consecutive measurements separated by a 1-week period) despite two anti-hypertensive medications
- Uncontrolled type 1 and 2 diabetes
- Total cholesterol level above 6 mmol/L in blood
- Physical/laboratory/vital sign abnormalities that would, in the opinion of the investiga-tor, put the subject at undue risk or interfere with the interpretation of study results
- Active herpes simplex or herpes zoster
- Known human immunodeficiency virus, tuberculosis, hepatitis B or C
- Pregnancy or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- • To evaluate complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and the overall response rate to treatment with Xeljanz.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
XELJANZ 10 mg film-coated tablets
PRD6483620 · Product
- Active substance
- Tofacitinib
- Substance synonyms
- CP-690,550, TASOCITINIB
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA29 — -
- Marketing authorisation
- EU/1/17/1178/006
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Klinik for Hud- og Kønssygdomme
Public contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Klinik for Hud- og Kønssygdomme
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 15 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-01-10 | 2025-08-06 | 2023-01-10 | 2024-12-18 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-04-22 | Denmark | Acceptable 2022-07-04
|
2022-07-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-11-10 | Denmark | Acceptable 2022-12-09
|
2022-12-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-18 | Denmark | Acceptable 2024-02-07
|
2024-02-14 |