A Phase 4 (Phase 2 in European Union), Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion in Pediatric Subjects with Moderate to Severe Plaque Psoriasis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bausch Health Americas Inc.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

9 Mar 2021 → 6 Nov 2025

Decision date (initial)

2025-01-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-520057-20-00

EudraCT number

2019-002406-43

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others

1.) Safety of IDP-118 (HP 0.01% and Taz 0.045%) Lotion administered topically once daily for 8 weeks
2.) Systemic exposure of HP and Taz from IDP-118 Lotion when applied once daily for 4 weeks
3.) HPA axis suppression potential for IDP-118 Lotion when applied once daily for 8 weeks

Conditions and MedDRA coding

Plaque Psoriasis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Male or female, of any race, 12 to 16 years 11 months of age at the time of informed consent/assent obtained
2. Verbal and written informed consent/assent obtained from the subject and/or parent or legal guardian.
3. Has a clinical diagnosis of psoriasis at the Screening and Baseline visit with an Investigator’s Global Assessment (IGA) score of 3 or 4. The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present
4. Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, axillae, and intertriginous areas are to be excluded in this calculation.
5. Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
6. Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is > 18 μg/dL at screening.
7. Is in good general health based on the subject’s medical history and a physical examination, with screening hematology and serum chemistry laboratory values within normal ranges or not clinically significant, as determined by the investigator
8. Pre-menses females (9 and older) and females of childbearing potential, must have a negative urine and serum pregnancy test at Screening and a negative urine pregnancy test at the Baseline visit prior to study drug application .
9. Females of childbearing potential and females who are pre-menses (9 and older) must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.). Females on birth control pills must have taken the same type pill for at least three months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least three months prior to the start of the study.
10. Subject is willing to comply with study instructions and return to the clinic for required visits.

Exclusion criteria 18

1. Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
2. Has a history of adrenal disease.
3. Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
4. Is pregnant, nursing an infant, or planning a pregnancy during the study period.
5. Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to baseline, or is concurrently participating in another clinical study with an investigational drug or device
6. Received treatment with a topical antipsoriatic drug product other than corticosteroids or Taz-based therapy within 14 days prior to the Baseline visit, and/or treatment containing Taz within 28 days prior to the Baseline visit, and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test
7. Has used any phototherapy (including laser), photochemotherapy, or systemic non-biologic psoriasis therapy (such as newer oral psoriasis medications [eg, Otezla], methotrexate, retinoids or cyclosporine) within 4 weeks prior to the Baseline visit, or systemic corticosteroids within 28 days prior to the screening HPA axis stimulation test.
8. Has used immunomodulatory therapy (e.g., biologics) known to affect psoriasis within 3 months of baseline.
9. Has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 4 weeks prior to screening or is intending to have exposure during the study thought likely by the investigator to modify the subject’s psoriasis
10. Is currently using lithium or Plaquenil.
11. Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
12. Is unable to be compliant with study procedures, study drug administration requirements, study visit schedules, and prohibitions regarding the use of concomitant medications/therapies.
13. Is unable to communicate or cooperate with the investigator.
14. Has any underlying disease deemed uncontrolled by the investigator that poses a concern for the subject’s safety while participating in the study
15. Has a history of drug or alcohol abuse as determined by the investigator.
16. Is considered by the investigator, for any other reason, to be an unsuitable candidate for the study.
17. Has an abnormal sleep schedule or works at night.
18. Has a history of an adverse reaction to cosyntropin injection or similar test reagents.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1.) 1 Safety of IDP-118 (HP 0.01% and Taz 0.045%) Lotion administered topically once daily 2.) Systemic exposure of HP, Taz and its metabolite, tazarotenic acid after topical application of IDP-118 Lotion once daily 3.) Hypothalamic-pituitary-adrenal (HPA) axis suppression potential for IDP-118 Lotion when applied once daily

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bausch Health Americas Inc.

Sponsor organisation

Bausch Health Americas Inc.

Address

400 Somerset Corporate Boulevard

City

Bridgewater

Postcode

08807-2867

Country

United States

Scientific contact point

Organisation

Bausch Health Americas Inc.

Contact name

Sean Humphrey

Public contact point

Organisation

Bausch Health Americas Inc.

Contact name

Sean Humphrey

Third parties 4

Locations

1 EU/EEA country · 6 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 6 files

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

Application history

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