Last updated: 10/28/2025 13:50:14
Characterization of the interferon response following a cutaneous ultraviolet B (UVB) challenge
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open-label study to characterise the interferon signature following a cutaneous ultraviolet B challenge in male and female healthy participants aged 18 to 60 years, and to provide insight into its relevance to patients with cutaneous lupus erythematosus
Trial description: This single center, two-part, open-label non-investigational product study will assess the ability of UVB challenge to activate the interferon pathway in healthy volunteers and aid the development of methodologies for use in early clinical studies to assess the pharmacology of novel therapeutic interventions targeting the interferon pathway.
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Part 1: Fold-change pre- to post-UVB challenge in messenger ribonucleic acid (mRNA) expression of genes associated with activation of interferon pathway (IRF7, IRF1, CXCL10, ISG20 and MX1)
Timeframe: Baseline and 6 hour post-UVB challenge
Secondary outcomes:
Part 1: Number of participants with adverse events (AEs) related to study procedures and serious adverse events (SAEs)
Timeframe: Up to 6 weeks
Part 1: Number of participants with tolerability of UVB challenge
Timeframe: Up to 6 weeks
Part 1: Fold-change pre- to post-UVB challenge of inflammatory genes interleukin (IL)-6 and chemokine (C-C motif) ligand 2 (CCL2)
Timeframe: Baseline and 6 hour post-UVB challenge
Interventions:
Radiation: Ultraviolet B
Other: No Ultraviolet B
Enrollment:
32
Observational study model:
Cohort
Primary completion date:
2022-06-10
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
healthy volunteers, Cutaneous lupus erythematosus
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2021 to October 2024
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 60 Years
Accepts healthy volunteers
Yes
- Inclusion Criteria (Healthy and participants with CLE):
- Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent form.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria (Healthy and participants with CLE):
- Participant must be 18 to 60 years of age inclusive, at the time of signing the informed consent form.
- Body weight within greater than (>) 50 kilogram (kg) and body mass index (BMI) within the range 19.5 to 32 kilogram per meter square (kg/m^2) (inclusive).
- Both male and female participants are eligible. A female participant is eligible to participate if she is not pregnant or breastfeeding. There are no requirements for contraception in this study.
- Capable of giving signed informed consent as described in the protocol. Healthy Participants only:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests and cardiac monitoring.
- Fitzpatrick skin type I, II or III. Participants with CLE only:
- A confirmed diagnosis of subacute or chronic CLE, with or without concurrent systemic lupus erythematosus, as determined by the Investigator.
- A cutaneous lupus lesion in a suitable location for biopsy. Exclusion Criteria (Healthy and participants with CLE):
- History or presence of excessive bleeding or coagulation disorders that in the opinion of the Investigator (in discussion with the Medical Monitor as needed) poses a safety risk with regards to participation in the trial.
- History or presence of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones).
- History of adverse reaction to local anesthetic.
- An active infection within 30 days prior to any study procedures.
- A positive Corona virus disease-2019 (COVID-19) test result or high clinical index of suspicion of COVID-19 infection within the last 30 days, or with known COVID-19 positive contacts within 14 days prior to any study visits.
- The participant has a clinically significant abnormality in the hematological or clinical chemistry screen.
- For analgesia, paracetamol (acetaminophen) at doses lesser than or equal to (<=) 4 grams per day (g/day) is permitted. Non-steroidal anti-inflammatory drugs (NSAIDs) are not permitted in <=7 days prior to any study procedures.
- Any other medication, herbal supplement or dietary supplement.
- The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives (whichever is longer) of the Screening Visit. Participants who have received investigational products with expected prolonged pharmacodynamic effects (example. B cell depletion) may also be excluded at the discretion of the Investigator (in discussion with the Medical Monitor as needed).
- A woman of child-bearing potential must have a negative highly sensitive urine pregnancy test at the Screening Visit and at the Day 1 Visit. If a urine test cannot be confirmed as negative (example, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Alanine aminotransferase (ALT), alkaline phosphatase or bilirubin >=1.5 x upper limit normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at the Screening Visit.
- Electrocardiogram (ECG) with a clinically significant abnormality at the discretion of the investigator/designee. QT interval corrected for heart rate according to Fridericia’s formula (QTcF) >480 milliseconds (msec). Based on averaged QTc values of triplicate ECGs obtained over a brief recording period.
- The participant has a phobia to needles or minor surgical procedures (including skin biopsy and raising of suction blisters), or the proposed area(s) for study procedures are not acceptable to the participant. Healthy Participants only:
- History or presence of malignant skin conditions or photosensitivity.
- History of benign skin conditions including but not limited to atopic dermatitis, chronic eczema, psoriasis, urticaria, vitiligo, that in the opinion of the Investigator would impact study participation.
- History or presence of post-inflammatory hyperpigmentation, or keloid or hypertrophic scaring.
- History or presence immunodeficiency or autoimmunity.
- Current use of prescription drugs or non-prescription drugs from 7 days prior to Day 1 Visit. This includes topical, inhaled and systemic steroids, and any other immune modulators. Any washout period will be determined on a case-by-case basis by the Investigator (in consultation with the Medical Monitor as needed). Any photosensitizing drugs should not be taken within 5 half-lives of the Screening Visit.
- Vaccination (including either first dose or booster against COVID-19) within 28 days of Screening Visit or planned before Day 2 Visit.
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) within 90 days of the Screening Visit.
- Positive hepatitis C antibody test within 90 days of the Screening Visit.
- Positive human immunodeficiency virus (HIV) antibody test within 90 days of the Screening Visit.
- A white blood cell count outside the normal range, or a C-reactive protein >5 milligram per liter (mg/L).
- Estimated glomerular filtration rate (eGFR) <60 milliliter per minute per 1.73 meter square (mL/min/1.73m2) at the Screening Visit.
- A minimal erythema dose (MED) not identified at Screening Visit.
- The presence of widespread acne, freckles, naevi, tattoos, birthmarks, piercings, scarring or other skin variations within the proposed UVB challenge area. Investigator discretion may be used to determine if small areas may be avoided in the challenge area.
- Direct exposure to UV (example: sunbathing or artificial tanning devices) to the areas of the body to be studied within 2 weeks of the Screening Visit.
- Unable to refrain from exposure to extended and direct sunlight or use of artificial tanning devices from the Screening Visit to Day 2 Visit.
- Use of self-tanning products on the area of the body to be studied within 2 weeks of the Screening Visit.
- Unable to refrain from using sun blocking, self-tanning or other topical dermatological products (including moisturizers and makeup) on the areas of the body to be studied for the duration of the study period.
- Regular use of known drugs of abuse during the 6 months prior to and including the Screening Visit. Participants with CLE only:
- History or presence of inflammatory skin conditions (other than CLE), including but not limited to atopic dermatitis, chronic eczema, psoriasis, urticaria or vitiligo, which in the opinion of the Investigator would impact study participation
- History or presence of keloid or hypertrophic scaring.
- Use of prescription drugs or non-prescription drugs.
- Prednisolone (or equivalent) >7.5 milligram (mg) daily for 28 days prior to the Screening Visit, or any increase in dose prior to Day 1 Visit.
- Hydroxychloroquine >5 milligram per kilogram (mg/kg) daily within 120 days prior to the Screening Visit, or any increase in dose prior to Day 1 Visit.
- Change in dose of other oral immunosuppressants within 120 days prior to the Screening Visit, or any increase in dose prior to Day 1 Visit.
- Biologic agents (including monoclonal antibodies), chemotherapeutic agents, plasma exchange or intravenous immunoglobulin within 12 months prior to the Screening Visit.
- Treatment with an anti-platelet or anti-coagulant <=14 days prior to Day 1 Visit, with the exception of aspirin up to 75 mg daily.
- Vaccination (including either first dose or booster against COVID-19) within 28 days of Screening Visit or planned before Day 1 Visit.
- Positive HBsAg or HBcAb within 90 days of the Day 1 Visit.
- Positive hepatitis C antibody test within 90 days of the Day 1 Visit.
- Positive HIV antibody test within 90 days of the Day 1 Visit.
- Unable to refrain from using sun blocking, self-tanning or other topical dermatological products (including moisturizers and makeup) on the areas of the body to be studied from the Screening to Day 1 Visit.
- Regular use of known drugs of abuse during the 6 months prior to screening.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2022-06-10
Actual study completion date
2024-29-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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