Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

• Sponsor: Clinuvel Pharmaceuticals Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04704713
• Collaborator: (none)
• Enrollment: 31
• Arms: 2

Study Details

Study Description

Brief Summary

This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).

Condition or Disease	Intervention/Treatment	Phase
Polymorphic Light Eruption	Drug: Afamelanotide; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomised, Double Blind, Placebo Controlled, Parallel Group Study, to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide (16 mg) in Patients Suffering From Polymorphic Light Eruption (PLE)
• Actual Study Start Date: May 5, 2010
• Actual Primary Completion Date: Dec 9, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Afamelanotide Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.	Drug: Afamelanotide
Placebo Comparator: Placebo Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale [From Day 0 to Day 120]

   PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus).

Secondary Outcome Measures

1. Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries [From Day 0 to Day 120]

2. Duration of PLE Episodes Recorded in Paper Patient Diaries [From Day 0 to Day 120]

3. Quality of Life Using the Dermatology Life Quality Index (DLQI) [At Day 0, Day 60 and Day 120]

   The DLQI questionnaire consists of 10 questions, each answered on a categorical scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Aged greater than 18 years

• Male or female patients with a documented history of PLE diagnosed or confirmed by a photodermatologist or photobiologist, with a history of PLE related pruritus symptoms.

• Recurrent PLE episodes that occur at least once a year (as evidenced by PLE related pruritus symptoms) developing in their own country (to exclude patients affected only when traveling to sunnier climates)

• Written informed consent prior to the performance of any study-specific procedure

• Are willing and able to comply with the conditions specified in the protocol and study procedures in the opinion of the Investigator

Exclusion Criteria:

• Currently requiring treatment with systemic immunosuppressive agents

• Documented history of other photosensitivity conditions which may be confused with PLE or interfere with the assessment of PLE episodes

• Solarium use in the three months prior to study involvement and throughout the duration of the study

• Use of immunosuppressive medications, drugs that cause hyperpigmentation or any other treatment that in the opinion of the Investigator may interfere with this study

• Documented presence (> 1 in 320) of Anti-Nuclear Antibody (ANA) and/or positive Extractable Nuclear Antibody (ENA); historical results from the 3 years prior to randomisation are acceptable if available

• In the opinion of the Investigator, any evidence of clinically significant organ dysfunction, or any clinically significant deviation from normal in clinical or laboratory parameters

• History of drug or alcohol abuse (in the last 1 year)

• Female who is pregnant (confirmed by positive serum beta-Human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating

• Female of child-bearing potential (pre-menopausal, not surgically sterile) that is not using or is not willing to use adequate contraceptive measures (e.g. oral contraceptives, condoms, diaphragm plus spermicide, intrauterine device)

• Sexually active men with partners of child bearing potential not willing to use barrier contraception during the trial and for a period of three months thereafter

• Participation in a clinical trial with another Investigational Medicinal Product (IMP) within 30 days prior to the Screening visit or during the study

• Hypersensitivity to afamelanotide or any of its components

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Clinuvel Pharmaceuticals Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clinuvel Pharmaceuticals Limited
• ClinicalTrials.gov Identifier: NCT04704713
• Other Study ID Numbers: CUV032
• First Posted: Jan 12, 2021
• Last Update Posted: Mar 19, 2021
• Last Verified: Feb 1, 2021

• Additional relevant MeSH terms: Exanthema; Dermatitis, Contact; Afamelanotide

Study Results

Participant Flow

Arm/Group Title	Afamelanotide	Placebo
Arm/Group Description	Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Afamelanotide	Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Placebo
Period Title: Overall Study
STARTED	15	16
COMPLETED	11	12
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Afamelanotide	Placebo	Total
Arm/Group Description	Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Afamelanotide	Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Placebo	Total of all reporting groups
Overall Participants	15	16	31
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	15 100%	16 100%	31 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	11 73.3%	14 87.5%	25 80.6%
Male	4 26.7%	2 12.5%	6 19.4%

Outcome Measures

1. Primary Outcome

Title	Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale
Description	PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus).
Time Frame	From Day 0 to Day 120

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Afamelanotide	Placebo
Arm/Group Description	Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Afamelanotide	Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Placebo
Measure Participants	15	16
Median (Full Range) [score on a scale]	0.25	0.47

2. Secondary Outcome

Title	Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries
Time Frame	From Day 0 to Day 120

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Duration of PLE Episodes Recorded in Paper Patient Diaries
Time Frame	From Day 0 to Day 120

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Quality of Life Using the Dermatology Life Quality Index (DLQI)
Description	The DLQI questionnaire consists of 10 questions, each answered on a categorical scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time Frame	At Day 0, Day 60 and Day 120

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Afamelanotide		Placebo
Arm/Group Description	Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Afamelanotide		Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit. Placebo
All Cause Mortality
	Afamelanotide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Afamelanotide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Afamelanotide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/15 (46.7%)		3/16 (18.8%)
Gastrointestinal disorders
Diarrhoea	1/15 (6.7%)		2/16 (12.5%)
Hypoaesthesia oral	1/15 (6.7%)		0/16 (0%)
Nausea	3/15 (20%)		0/16 (0%)
Gastritis	0/15 (0%)		1/16 (6.3%)
General disorders
Device expulsion	0/15 (0%)		1/16 (6.3%)
Fatigue	2/15 (13.3%)		0/16 (0%)
Infections and infestations
Nasopharyngitis	3/15 (20%)		3/16 (18.8%)
Influenza	1/15 (6.7%)		0/16 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/15 (6.7%)		2/16 (12.5%)
Nervous system disorders
dizziness	1/15 (6.7%)		0/16 (0%)
Dysgeusia	1/15 (6.7%)		0/16 (0%)
Headache	4/15 (26.7%)		3/16 (18.8%)
Respiratory, thoracic and mediastinal disorders
Sinusitis	1/15 (6.7%)		1/16 (6.3%)
Vascular disorders
Hypertension	1/15 (6.7%)		1/16 (6.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.