Deucralip

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rheinische Friedrich Wilhelms Universitaet Bonn

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Trial duration

22 May 2024 → ongoing

Decision date (initial)

2023-12-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bristol-Myers Squibb

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacogenetic, Therapy

Evaluation of the efficacy of deucravacitinib on objective clinical symptoms/ disease activity in lichen planus patients

Secondary objectives 4

1. To assess whether the administration of deucravacitinib in lichen planus patients is associated with reduced inflammatory parameters (from blood and skin samples or (only in case of solely oral involvement) from a lesional oral mucosa swab) => mRNA-based gene expression analysis of IFN genes (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.)
2. To assess whether the administration of deucravacitinib in lichen planus patients is associated with improvement of quality of life (Dermatological Quality of Live Index = DLQI, validated score)
3. To assess whether the administration of deucravacitinib in lichen planus patients is associated with improvement of itching via the Numeric rating scale (NRS) for average itch during the past 24 hours
4. To assess whether the administration of deucravacitinib in lichen planus patients is associated with improvement/reduction of the amount of steroids used

Conditions and MedDRA coding

Lichen planus

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Subjects male or female, aged ≥18 years
2. The subject has given written informed consent to participate in the trial
3. Subjects with histologically proven and symptomatic lichen planus
4. Ability to follow study instructions and willingness to attend and complete all required visits
5. LiPADI Acivity Score ≥ 6 or ≥ 3 in patients with mucosal involvement only

Exclusion criteria 22

1. Subjects without legal capacity are unable to understand the nature, scope, significance and consequences of this clinical trial
2. Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
3. Reported history (within the last 12 months before screening) or persistent abuse of medication, drugs or alcohol in the assessment of the medical practitioner investigator, considering safety and trial and medication adherence of the participant
4. Known allergy/ incompatibility against deucravacitinib
5. Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product (except for DEUCRALIP/deucravacitinib for lichen planus), up to 120 days prior to participation in that clinical trial
6. Subjects with a history of malignant neoplasm within the last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years
7. Chronic or acute infectious disease (including but not limited to HIV, Hepatitis B or C infection, Tbc or latent Tbc infection), disease predisposing for infectious disease or recurring infectious diseases in the history
8. Hospitalization for treatment of infection within 60 days prior to Day 1
9. History of serious herpes zoster or serious herpes simplex infection, which includes, but is not limited to, any episode of disseminated herpes simplex, multidermatomal herpes zoster, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (recurrent is defined as 2 episodes within 2 years)
10. Subjects with a history of a primary immunodeficiency
11. Subjects with severe hepatic impairment (Child-Pugh C)
12. Subjects who neither received a COVID-vaccination following EU regulations nor experienced a COVID-19 infection
13. Subjects who will need to receive a COVID-vaccination with an mRNA vaccine during the double-blind phase of the study
14. Subjects who will need to receive routine-vaccination during the study period (Comment: Lichen planus is an IFN-mediated inflammatory disease which is prone to worsen after application of vaccines, due to their IFN-stimulating effects)
15. Subjects with clinically significant abnormal laboratory value in the opinion of the investigator
16. Subjects treated within the last 8 weeks before baseline/day 1 with oral deucravacitinib or any other systemic JAK/TYK-specific inhibitor
17. Subjects treated within the last 8 weeks before baseline/day 1 with any systemic immunosuppressive/ immunomodulatory agent, other than SOC-medications (for SOC-medications see chapter 10.15.3.)
18. Patient treated within the last 12 weeks before baseline/day 1 with any systemic retinoid
19. Subjects treated topically within the last 4 weeks before baseline/day 1 with a topical class III or class IV steroid (as shown in Figure 3) and/ or other topical immunosuppressive agents, other than SOC-medications (for SOC-medications see chapter 10.15.3.)
20. Women who are currently pregnant (positive pregnancy test, e.g. β-hCG test in urine/serum) or lactating women
21. Women with a planned pregnancy within the study period and 16 weeks thereafter
22. Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration and 16 weeks thereafter (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in the objective clinical symptoms (measured with the Lichen Planus Activity and Damage Index(LiPADI) Activity Score, from baseline (V1, day 1) to EOS (V4, day 112)

Secondary endpoints 8

1. Change in the LiPADI Activity Score from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3 and OLE-V3 in both arms
2. Differences in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1, EOS/V4, OLE-V3) between placebo and treatment arm
3. Change in IFN gene expression profile (CXCL10, CXCL9, CCL5, MxA, BLyS, TRAIL etc.) in peripheral blood and skin or (only in case of solely oral involvement) in lesional oral mucosa (BOS/V1 vs EOS/V4 vs OLE-V3) in both arms
4. Change of DLQI from baseline (V1) to EOS (V4) between placebo and treatment arm
5. Change of DLQI from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3, OLE-V3 in both arms
6. Change of Itch NRS from baseline (V1) to EOS (V4) between placebo and treatment arm
7. Change of Itch NRS from baseline (V1) to V3, V4/OLE-V1, SC-1, SC-2, OLE-V2, SC-3, OLE-V3 in both arms
8. Change in the amount of steroids used from baseline (V1) to EOS (V4) between placebo and treatment arm

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rheinische Friedrich Wilhelms Universitaet Bonn

Sponsor organisation

Rheinische Friedrich Wilhelms Universitaet Bonn

Address

Venusberg-Campus 1, Venusberg Venusberg

City

Bonn

Postcode

53127

Country

Germany

Scientific contact point

Organisation

Rheinische Friedrich Wilhelms Universitaet Bonn

Contact name

Jörg Wenzel

Public contact point

Organisation

Rheinische Friedrich Wilhelms Universitaet Bonn

Contact name

Jörg Wenzel

Third parties 1

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 31 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications